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Intramedullary nailing versus plating for extra-articular distal tibial metaphyseal fracture: A systematic review and meta-analysis

  • Author Footnotes
    1 Tel.: +86 571 15088681606; fax: +86 571 86806079.
    Xing-He Xue
    Footnotes
    1 Tel.: +86 571 15088681606; fax: +86 571 86806079.
    Affiliations
    Department of Orthopaedic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University, No. 88 Jiefang Road, Hangzhou 310009, PR China
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  • Shi-Gui Yan
    Affiliations
    Department of Orthopaedic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University, No. 88 Jiefang Road, Hangzhou 310009, PR China
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  • Xun-Zi Cai
    Correspondence
    Corresponding author. Tel.: +86 571 13750838226; fax: +86 571 86806079.
    Affiliations
    Department of Orthopaedic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University, No. 88 Jiefang Road, Hangzhou 310009, PR China
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  • Ming-Min Shi
    Affiliations
    Department of Orthopaedic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University, No. 88 Jiefang Road, Hangzhou 310009, PR China
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  • Tiao Lin
    Affiliations
    Department of Orthopaedic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University, No. 88 Jiefang Road, Hangzhou 310009, PR China
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  • Author Footnotes
    1 Tel.: +86 571 15088681606; fax: +86 571 86806079.

      Abstract

      Introduction

      With development in the techniques of reduction and fixation, there has been a controversy in comparison between intramedullary nailing (IMN) and plating for the treatment of distal tibial metaphyseal fracture (DTF). The study aimed to investigate: (1) which fixation, IMN or plating, was better in the clinical outcomes and in the complications for the treatment of DTF and (2) which modifying variables affected the comparative results between the two modalities.

      Methods

      PubMed, EMBASE, OVID, Scopus, ISI Web of Science, the Cochrane Library, Google Scholar and specific orthopaedic journals were searched from inception to July 2013, using the search strategy of ‘(‘Fracture Fixation, Intramedullary’ [MeSH]) AND (‘Tibial Fractures’ [MeSH]) AND (plate OR plating)’. All prospective and retrospective controlled trials comparing function, pain, bone union and complications between IMN and plating for DTF were identified. Our analysis had no limitation of the language or the publication year. The primary outcome measurements were complication rate, union time, operation time and hospital stays, while the secondary outcome measurements were functional score and pain score.

      Result

      Fourteen of 6620 studies with 842 patients were included. IMN was probably preferential to plating for DTF given its higher functional score (p = 0.01), lower risk of infection (p = 0.02) and comparable pain score (p = 0.33), total complication rate (p = 0.53) and time to union (p = 0.86). However, plating had a lower malunion rate than IMN (p < 0.0001). All the results were based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence of moderate quality.

      Conclusions

      With a satisfying alignment obtained, IMN may be preferential to plating for fixation of DTF with better function and lower risk of infection. However, IMN showed higher malunion rate for fixation of DTF. With the biases in our meta-analysis, it will ultimately require a rigorous and adequately powered randomised controlled trial (RCT) to prove.

      Level of evidence

      Level III, therapeutic study (systematic review).

      Keywords

      Introduction

      Tibial metaphyseal fractures (TMFs) contain both distal tibial metaphyseal fractures (DTFs, Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) type 43 or distal 42) and proximal metaphyseal tibial fractures (PTFs, AO/OTA type 41 or proximal 42) [
      • Marsh J.L.
      • Slongo T.F.
      • Agel J.
      • Broderick J.S.
      • Creevey W.
      • DeCoster T.A.
      • et al.
      Fracture and dislocation classification compendium – 2007: Orthopaedic Trauma Association Classification, Database and Outcomes Committee.
      ], which account for 3–10% and 5–11% of total tibial fractures, respectively [
      • Hiesterman T.G.
      • Shafiq B.X.
      • Cole P.A.
      Intramedullary nailing of extra-articular proximal tibia fractures.
      ,
      • Bedi A.
      • Le T.T.
      • Karunakar M.A.
      Surgical treatment of nonarticular distal tibia fractures.
      ]. With the severe damage of soft tissue and the extreme instability, TMFs have a high risk of unsatisfactory function, severe pain, delayed union, malunion and infection [
      • Hiesterman T.G.
      • Shafiq B.X.
      • Cole P.A.
      Intramedullary nailing of extra-articular proximal tibia fractures.
      ,
      • Bhandari M.
      • Audige L.
      • Ellis T.
      • Hanson B.
      Operative treatment of extra-articular proximal tibial fractures.
      ]. The established treatments include intramedullary nailing (IMN) and plating.
      Plating has been accepted as the first choice for DTF [
      • Zelle B.A.
      • Bhandari M.
      • Espiritu M.
      • Koval K.J.
      • Zlowodzki M.
      Treatment of distal tibia fractures without articular involvement: a systematic review of 1125 fractures.
      ], which ensures accurate reduction and rigid fixation. Unfortunately, extensive dissection of the host bone and the soft tissue is mandatory. It inevitably raises the risk of infection and nonunion. Furthermore, the complaint about hardware irritation makes it prone to be removed [
      • Zelle B.A.
      • Bhandari M.
      • Espiritu M.
      • Koval K.J.
      • Zlowodzki M.
      Treatment of distal tibia fractures without articular involvement: a systematic review of 1125 fractures.
      ]. IMN is the gold standard for tibial diaphyseal fractures. It has a small influence on the blood supply of the host tissue, which would contribute to a low rate of nonunion and infection [
      • Bhandari M.
      • Audige L.
      • Ellis T.
      • Hanson B.
      Operative treatment of extra-articular proximal tibial fractures.
      ,
      • Zelle B.A.
      • Bhandari M.
      • Espiritu M.
      • Koval K.J.
      • Zlowodzki M.
      Treatment of distal tibia fractures without articular involvement: a systematic review of 1125 fractures.
      ]. Initially, the extreme high malunion rate and the poor function prevented orthopaedic surgeons from using IMN for DTF [
      • Zelle B.A.
      • Bhandari M.
      • Espiritu M.
      • Koval K.J.
      • Zlowodzki M.
      Treatment of distal tibia fractures without articular involvement: a systematic review of 1125 fractures.
      ]. Biomechanical experiments showed that even the reamed IMN could not fit with the lenient medullary canal of the tibia metaphysis [
      • Bong M.R.
      • Kummer F.J.
      • Koval K.J.
      • Egol K.A.
      Intramedullary nailing of the lower extremity: biomechanics and biology.
      ]. Of the two fracture ends, the short part lacked the cortical friction with implants and the adequate purchase of locking screws so that the tibial alignment could be neither obtained nor maintained [
      • Bong M.R.
      • Kummer F.J.
      • Koval K.J.
      • Egol K.A.
      Intramedullary nailing of the lower extremity: biomechanics and biology.
      ]. Given these inherent defects, IMNs were limited or even relatively contradicted for DTF.
      With the emerging shortened and multidirectional interlocking IMN, for example, the distal locking nail (DLN) [
      • Hiesterman T.G.
      • Shafiq B.X.
      • Cole P.A.
      Intramedullary nailing of extra-articular proximal tibia fractures.
      ], and the evolving reduction techniques, for example, the blocking screw (BS) and other percutaneous reduction techniques (PRTs) [
      • Hiesterman T.G.
      • Shafiq B.X.
      • Cole P.A.
      Intramedullary nailing of extra-articular proximal tibia fractures.
      ], the interest in applying IMN to TMFs has been renewed. The claimed improvement in the alignment and the stability has been confirmed both in the laboratory and in the clinical follow-up [
      • Hiesterman T.G.
      • Shafiq B.X.
      • Cole P.A.
      Intramedullary nailing of extra-articular proximal tibia fractures.
      ,
      • Bedi A.
      • Le T.T.
      • Karunakar M.A.
      Surgical treatment of nonarticular distal tibia fractures.
      ,
      • Bong M.R.
      • Kummer F.J.
      • Koval K.J.
      • Egol K.A.
      Intramedullary nailing of the lower extremity: biomechanics and biology.
      ]. Meanwhile, the novel technique of minimally invasive plating osteosynthesis (MIPO) has been developed to further alleviate the local damage of plating [
      • Bedi A.
      • Le T.T.
      • Karunakar M.A.
      Surgical treatment of nonarticular distal tibia fractures.
      ].
      At present, there has been a great controversy on the ideal surgical option for DTF. A large amount of studies compared IMN with plating [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      ,
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ,
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      ,
      • Mauffrey C.
      • McGuinness K.
      • Parsons N.
      • Achten J.
      • Costa M.L.
      A randomised pilot trial of locking plating fixation versus intramedullary nailing for extra-articular fractures of the distal tibia.
      ,
      • Chen N.
      • He Q.Q.
      Clinical analysis for two fixation methods in distal tibiofibular fracture.
      ,
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ,
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      ,
      • Vallier H.A.
      • Le T.T.
      • Bedi A.
      Radiographic and clinical comparisons of distal tibia shaft fractures (4 to 11 cm proximal to the plafond): plating versus intramedullary nailing.
      ,
      • Yang S.W.
      • Tzeng H.M.
      • Chou Y.J.
      • Teng H.P.
      • Liu H.H.
      • Wong C.Y.
      Treatment of distal tibial metaphyseal fractures: plating versus shortened intramedullary nailing.
      ,
      • Zhang C.
      • Jiang Y.
      • An Z.Q.
      Interlocking intramedullary nailing versus percutaneous plating in osteosynthesis of metaphyseal fractures of distal tibia.
      ,
      • Zhu H.W.
      Interlocking intramedullary nail for distal tibial fracture.
      ,
      • Seyhan M.
      • Unay K.
      • Sener N.
      Intramedullary nailing versus percutaneous locked plating of distal extra-articular tibial fractures: a retrospective study.
      ]. Limited by the sample size, they failed to show a clear superiority of one modality over the other. To address this, the present systematic review and meta-analysis is aimed to cover all the comparative evidence with the purpose of determining: (1) which fixation, IMN or plating, was better in the clinical outcomes and in the complications for the treatment of DTF and (2) which modifying variables affected the comparative results between two modalities.

      Materials and methods

      Three reviewers (XHX, XZC and MMS) searched PubMed (1966 to July 2013), EMBASE (1974 to July 2013), Ovid (1966 to July 2013), Scopus (1966 to July 2013), ISI Web of Science (1945 to July 2013), Cochrane Library, Clinical Trial Grade Center and Google Scholar (1966 to July 2013), Chinese VIP Database (1986 to July 2013) and Chinese Wan-Fang Database (1992 to July 2013) using the search strategy of ‘(‘Fracture Fixation, Intramedullary’ [MeSH]) AND (‘Tibial Fractures’ [MeSH]) AND (plate OR plating)’, plus ‘clinical trial’ AND ‘comparative study’ with no limitation of publication year or language. The reference lists of all the selected articles and the related orthopaedic journals were hand searched for any additional trials. In addition, we searched the Clinical Trial Registry, the Current Controlled Trials, the Trials Central and the Center Watch for grey literature. We defined the criteria of inclusion and exclusion before searching. We only included studies where: (1) DTF (AO/OTA type 43 or distal 42) was involved, (2) the age was ≥18, (3) both IMN and plating were adopted, (4) functional score, pain score or complication rate was assessed and (5) the design was comparative either prospectively or retrospectively. Exclusion criteria included studies where: (1) tibial isthmal fractures or AO type 43-C with serious intra-articular damages were involved, (2) neither of the outcomes was available, (3) the follow-up was <1 year and (4) no control data were provided. All the redundant publications were excluded. The abstracts of the rest of the publications were reviewed for relevance. Excluding the redundant publications and the unsatisfactory publications, the full texts of the rest of the publications were acquired and read in detail. We included the publications that satisfied our inclusion criteria.
      We contacted the corresponding authors of the eligible trials if necessary to verify the accuracy of the data abstraction as well as the methodological assessment. We also tried to get any further data or unpublished data which were useful for our data analysis.

      Methodological quality

      Three reviewers (XHX, SGY and MMS) assessed the methodological quality of the literature according to the 12-item scale [
      • Furlan A.D.
      • Pennick V.
      • Bombardier C.
      • van Tulder M.
      2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group.
      ]. The 12-item scale contained: randomised adequately, allocation concealed, similar baseline, patient blinded, care provider blinded, outcome assessor blinded, avoided selective reporting, similar or avoided cofactor, patient compliance, acceptable drop-out rate, similar timing and intention-to-treat (ITT) analysis. The inconsistent opinions were judged by another author (XZC). The disagreements were evaluated by the means of a kappa (κ) test and resolved by discussion. According to the 12-item standard (Table 1), five studies [
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      ,
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ,
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      ,
      • Mauffrey C.
      • McGuinness K.
      • Parsons N.
      • Achten J.
      • Costa M.L.
      A randomised pilot trial of locking plating fixation versus intramedullary nailing for extra-articular fractures of the distal tibia.
      ] explicitly described the randomisation and the concealment of the allocation assignment, six studies [
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      ,
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      ,
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ,
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      ,
      • Yang S.W.
      • Tzeng H.M.
      • Chou Y.J.
      • Teng H.P.
      • Liu H.H.
      • Wong C.Y.
      Treatment of distal tibial metaphyseal fractures: plating versus shortened intramedullary nailing.
      ] described the proper blinding and only one study [
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      ] described ITT analysis. The weighted kappa for the agreement on the trial quality between the reviewers was 0.85 (95% confidence interval (CI), 0.77–0.93).
      Table 1Methodological quality of the included studies based on the 12-items scoring system.
      StudyRandomised adequately
      Only if the method of sequence generated was explicitly described could get a “Yes”; sequence generated by “Dates of Admission” or “Patients Number” received a “No”.
      Allocation concealedSimilar baselinePatient blindedCare provider blindedOutcome assessor blindedAvoided selective reportingSimilar or avoided cofactorPatient compliance
      Intermittent treatment or therapy duration less than 6 months means “Yes”, otherwise “No”.
      Acceptable drop-out rate
      Drop-out rate>20% means “No”, otherwise “Yes”.
      Similar timingITT analysis
      ITT=intention-to-treat, only if all randomised patients are analysed in the group they were allocated to could receive a “Yes”.
      Quality
      “Yes” items greater than 7 means “High”; greater than 4 but no more than 7 means “Moderate”; no more than 4 means “Low”.
      Guo
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      YesYesYesUnclearUnclearUnclearYesYesYesYesYesNoHigh
      Im
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      YesYesYesNoUnclearYesYesYesYesYesYesNoHigh
      Janssen
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      NoNoYesYesUnclearUnclearYesYesYesNoYesNoModerate
      Yang
      • Yang S.W.
      • Tzeng H.M.
      • Chou Y.J.
      • Teng H.P.
      • Liu H.H.
      • Wong C.Y.
      Treatment of distal tibial metaphyseal fractures: plating versus shortened intramedullary nailing.
      NoNoYesUnclearUnclearYesYesYesYesUnclearYesNoModerate
      Vallier
      • Vallier H.A.
      • Le T.T.
      • Bedi A.
      Radiographic and clinical comparisons of distal tibia shaft fractures (4 to 11 cm proximal to the plafond): plating versus intramedullary nailing.
      NoNoYesUnclearUnclearUnclearYesYesYesUnclearYesNoModerate
      Vallier
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      YesYesYesYesUnclearYesYesYesYesYesYesYesHigh
      Vallier
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      YesYesYesYesUnclearYesYesYesYesYesYesNoHigh
      Mauffery
      • Mauffrey C.
      • McGuinness K.
      • Parsons N.
      • Achten J.
      • Costa M.L.
      A randomised pilot trial of locking plating fixation versus intramedullary nailing for extra-articular fractures of the distal tibia.
      YesYesYesUnclearUnclearUnclearYesYesYesYesYesNoHigh
      Li
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      NoNoYesUnclearUnclearYesYesYesYesUnclearYesNoModerate
      Seyhan
      • Seyhan M.
      • Unay K.
      • Sener N.
      Intramedullary nailing versus percutaneous locked plating of distal extra-articular tibial fractures: a retrospective study.
      NoNoYesUnclearUnclearUnclearYesYesYesUnclearYesNoModerate
      Zhang
      • Zhang C.
      • Jiang Y.
      • An Z.Q.
      Interlocking intramedullary nailing versus percutaneous plating in osteosynthesis of metaphyseal fractures of distal tibia.
      NoNoYesUnclearUnclearUnclearYesNoYesUnclearYesNoModerate
      Feng
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      NoNoYesUnclearUnclearUnclearYesUnclearYesUnclearYesNoModerate
      Chen
      • Chen N.
      • He Q.Q.
      Clinical analysis for two fixation methods in distal tibiofibular fracture.
      NoNoUnclearUnclearUnclearUnclearYesNoYesUnclearYesNoLow
      Zhu
      • Zhu H.W.
      Interlocking intramedullary nail for distal tibial fracture.
      NoNoYesUnclearUnclearUnclearYesYesYesYesUnclearNoModerate
      a Only if the method of sequence generated was explicitly described could get a “Yes”; sequence generated by “Dates of Admission” or “Patients Number” received a “No”.
      b Intermittent treatment or therapy duration less than 6 months means “Yes”, otherwise “No”.
      c Drop-out rate > 20% means “No”, otherwise “Yes”.
      d ITT = intention-to-treat, only if all randomised patients are analysed in the group they were allocated to could receive a “Yes”.
      e “Yes” items greater than 7 means “High”; greater than 4 but no more than 7 means “Moderate”; no more than 4 means “Low”.

      Analysis of the data

      Three reviewers (XHX, TL and MMS) extracted the relevant data and checked the accuracy (Table 2). Study design, sample size, age, gender, loss to follow-up, AO and Gustilo classification of DTFs, reduction technique, implants, fibular fixation, protocol of weight bearing and outcomes were abstracted. We used the ITT data from trials whenever it was possible. If the data were not reported in the original article, we extrapolated them from the accompanying graphs. Most of the studies were small scaled with the sample size ranging from 14 to 160. The total sample size was 443 for IMN and 399 for plating. As for IMN, one study [
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      ] adopted the DLN and the BS, and nine studies attempted the PRTs [
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      ,
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ,
      • Mauffrey C.
      • McGuinness K.
      • Parsons N.
      • Achten J.
      • Costa M.L.
      A randomised pilot trial of locking plating fixation versus intramedullary nailing for extra-articular fractures of the distal tibia.
      ,
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ,
      • Vallier H.A.
      • Le T.T.
      • Bedi A.
      Radiographic and clinical comparisons of distal tibia shaft fractures (4 to 11 cm proximal to the plafond): plating versus intramedullary nailing.
      ,
      • Zhang C.
      • Jiang Y.
      • An Z.Q.
      Interlocking intramedullary nailing versus percutaneous plating in osteosynthesis of metaphyseal fractures of distal tibia.
      ,
      • Zhu H.W.
      Interlocking intramedullary nail for distal tibial fracture.
      ,
      • Seyhan M.
      • Unay K.
      • Sener N.
      Intramedullary nailing versus percutaneous locked plating of distal extra-articular tibial fractures: a retrospective study.
      ]. Eight trials [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ,
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ,
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      ,
      • Chen N.
      • He Q.Q.
      Clinical analysis for two fixation methods in distal tibiofibular fracture.
      ,
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      ,
      • Yang S.W.
      • Tzeng H.M.
      • Chou Y.J.
      • Teng H.P.
      • Liu H.H.
      • Wong C.Y.
      Treatment of distal tibial metaphyseal fractures: plating versus shortened intramedullary nailing.
      ,
      • Zhu H.W.
      Interlocking intramedullary nail for distal tibial fracture.
      ,
      • Seyhan M.
      • Unay K.
      • Sener N.
      Intramedullary nailing versus percutaneous locked plating of distal extra-articular tibial fractures: a retrospective study.
      ] chose the locking plate and MIPO was applied in eight others [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      ,
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ,
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      ,
      • Vallier H.A.
      • Le T.T.
      • Bedi A.
      Radiographic and clinical comparisons of distal tibia shaft fractures (4 to 11 cm proximal to the plafond): plating versus intramedullary nailing.
      ,
      • Zhu H.W.
      Interlocking intramedullary nail for distal tibial fracture.
      ,
      • Seyhan M.
      • Unay K.
      • Sener N.
      Intramedullary nailing versus percutaneous locked plating of distal extra-articular tibial fractures: a retrospective study.
      ]. The fixation rates of the associated fibular fracture were >50% in seven studies [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ,
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      ,
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ,
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      ,
      • Yang S.W.
      • Tzeng H.M.
      • Chou Y.J.
      • Teng H.P.
      • Liu H.H.
      • Wong C.Y.
      Treatment of distal tibial metaphyseal fractures: plating versus shortened intramedullary nailing.
      ,
      • Zhang C.
      • Jiang Y.
      • An Z.Q.
      Interlocking intramedullary nailing versus percutaneous plating in osteosynthesis of metaphyseal fractures of distal tibia.
      ,
      • Seyhan M.
      • Unay K.
      • Sener N.
      Intramedullary nailing versus percutaneous locked plating of distal extra-articular tibial fractures: a retrospective study.
      ], <50% in four studies [
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      ,
      • Chen N.
      • He Q.Q.
      Clinical analysis for two fixation methods in distal tibiofibular fracture.
      ,
      • Vallier H.A.
      • Le T.T.
      • Bedi A.
      Radiographic and clinical comparisons of distal tibia shaft fractures (4 to 11 cm proximal to the plafond): plating versus intramedullary nailing.
      ] and unclear in three studies [
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ,
      • Mauffrey C.
      • McGuinness K.
      • Parsons N.
      • Achten J.
      • Costa M.L.
      A randomised pilot trial of locking plating fixation versus intramedullary nailing for extra-articular fractures of the distal tibia.
      ,
      • Zhu H.W.
      Interlocking intramedullary nail for distal tibial fracture.
      ]. According to the Gustilo Classification [
      • Fernandez-valencia J.A.
      How to quote Gustilo open fracture classification?.
      ], the fractures in six studies were exclusively closed or Gustilo I [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ,
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ,
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      ,
      • Mauffrey C.
      • McGuinness K.
      • Parsons N.
      • Achten J.
      • Costa M.L.
      A randomised pilot trial of locking plating fixation versus intramedullary nailing for extra-articular fractures of the distal tibia.
      ,
      • Chen N.
      • He Q.Q.
      Clinical analysis for two fixation methods in distal tibiofibular fracture.
      ,
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ] and the remaining eight also included Gustilo II or Gustilo III open fractures [
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      ,
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      ,
      • Vallier H.A.
      • Le T.T.
      • Bedi A.
      Radiographic and clinical comparisons of distal tibia shaft fractures (4 to 11 cm proximal to the plafond): plating versus intramedullary nailing.
      ,
      • Yang S.W.
      • Tzeng H.M.
      • Chou Y.J.
      • Teng H.P.
      • Liu H.H.
      • Wong C.Y.
      Treatment of distal tibial metaphyseal fractures: plating versus shortened intramedullary nailing.
      ,
      • Zhang C.
      • Jiang Y.
      • An Z.Q.
      Interlocking intramedullary nailing versus percutaneous plating in osteosynthesis of metaphyseal fractures of distal tibia.
      ,
      • Zhu H.W.
      Interlocking intramedullary nail for distal tibial fracture.
      ,
      • Seyhan M.
      • Unay K.
      • Sener N.
      Intramedullary nailing versus percutaneous locked plating of distal extra-articular tibial fractures: a retrospective study.
      ].
      Table 2Study characteristics and details of interventions of the included studies.
      StudyDesignSample size (IMN/plate)Age (years)Gender (male/female)Follow-up (month)Loss to follow upAO classificationInternal fixationReduction (IMN/plate)Fracture typeFixed fibula (percentage+)Inclusion criteria
      Guo
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      Prospective, randomised57/5444.3 (23–70)50/351213/1343-AR/MIPO, LCPPercutaneous/percutaneousClosed, Gustilo IUnclearExtra-articular (≥3 cm of distal fragment)
      Im
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      Prospective, randomised39/3941.1 (17–65)46/18245/943-A/C1
      43-C1 in this study had minimally displaced extension into articular surface which was almost as same as 43-A.
      R/LCPManual/openClosed, Gustilo I38 (59%)Extra-articular or minimally displaced extension into the ankle joint
      Janssen
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      Retrospective, nonrandomised12/1242.1 (25–84)12/1263N.A./N.A.42-A/B2
      All the 42-A cases were 4–11cm proximal from the tibial plafond.
      R/non-LCPPercutaneous/openClosed, Gustilo I22 (92%)Extra-articular, ≥18 years, closed or Gustilo I fracture
      Yang
      • Yang S.W.
      • Tzeng H.M.
      • Chou Y.J.
      • Teng H.P.
      • Liu H.H.
      • Wong C.Y.
      Treatment of distal tibial metaphyseal fractures: plating versus shortened intramedullary nailing.
      Retrospective, nonrandomised13/1451.5 (20–86)12/1533N.A./N.A.43-ANon-R/LCPManual/openClosed, Gustilo I/II/III27 (100%)Extra-articular (3–5 cm of the distance from the fracture line to ankle articular surface)
      Vallier
      • Vallier H.A.
      • Le T.T.
      • Bedi A.
      Radiographic and clinical comparisons of distal tibia shaft fractures (4 to 11 cm proximal to the plafond): plating versus intramedullary nailing.
      Multicentre, retrospective, nonrandomised76/3739.1 (16–77)77/3424N.A./N.A.42-A
      All the 42-A cases were 4–11cm proximal from the tibial plafond.
      R/MIPO, non-LCPPercutaneous/percutaneousClosed, Gustilo I/II/III42 (36%)Extra-articular (4–11 cm proximal from the tibial plafond)
      Vallier
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      Prospective, randomised56/4838.3 (18–95)85/1920N.A./N.A.42-A
      All the 42-A cases were 4–11cm proximal from the tibial plafond.
      R/MIPO, non-LCPPercutaneous/percutaneousClosed, Gustilo I/II/III28 (27%)Extra-articular (4–11 cm proximal from the tibial plafond)
      Vallier
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      Prospective, randomised56/4838.3 (18–95)73/132211/742-A
      All the 42-A cases were 4–11cm proximal from the tibial plafond.
      R/MIPO, non-LCPPercutaneous/percutaneousClosed, Gustilo I/II/III28 (27%)Extra-articular (4–11 cm proximal from the tibial plafond)
      Mauffery
      • Mauffrey C.
      • McGuinness K.
      • Parsons N.
      • Achten J.
      • Costa M.L.
      A randomised pilot trial of locking plating fixation versus intramedullary nailing for extra-articular fractures of the distal tibia.
      Prospective, randomised12/1241.5 (24–60)8/1612N.A./N.A.43-ANon-R/non-LCPPercutaneous/percutaneousClosed, Gustilo IUnclearExtra-articular (within two Müller squares of the ankle), >18 years, closed or Gustilo I
      Li
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      Retrospective, nonrandomised23/2338.0 (21–59)36/1024.7N.A./N.A.43-AETN/MIPO, LCPManual/manualClosed, Gustilo I/II/III42 (91%)Closed or Gustilo I/II fractures, skeletally mature, early failure of conservative treatment
      Seyhan
      • Seyhan M.
      • Unay K.
      • Sener N.
      Intramedullary nailing versus percutaneous locked plating of distal extra-articular tibial fractures: a retrospective study.
      Retrospective, nonrandomised25/3639.9 (19–81)34/2721.34N.A./N.A.43-AR, ETN/MIPO, LCPPercutaneous/percutaneousClosed, Gustilo I/II/III31 (51%)Extra-articular (4–10 cm proximal from the plafond)
      Zhang
      • Zhang C.
      • Jiang Y.
      • An Z.Q.
      Interlocking intramedullary nailing versus percutaneous plating in osteosynthesis of metaphyseal fractures of distal tibia.
      Retrospective, nonrandomised27/2441.2 (18–70)31/2021N.A./N.A.43-AR/non-LCPPercutaneous/openClosed, Gustilo I/II/III45 (88%)Extra-articular
      Feng
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      Retrospective, nonrandomised22/2844 (19–74)30/2012N.A./N.A.43-ANon-R/MIPO, LCPManual/percutaneousClosed, Gustilo I44 (88%)Extra-articular, Gustilo I/II, Tscherne 0–2
      Chen
      • Chen N.
      • He Q.Q.
      Clinical analysis for two fixation methods in distal tibiofibular fracture.
      Retrospective, nonrandomised25/2131 (21–50)38/824N.A./N.A.43-AR/LCPManual/openClosed, Gustilo I5 (11%)Extraarticular, middle and lower fracture, closed fracture
      Zhu
      • Zhu H.W.
      Interlocking intramedullary nail for distal tibial fracture.
      Retrospective, nonrandomised80/8038.8 (20–59)85/6222.46/743-AR/MIPO, LCPPercutaneous/openClosed, Gustilo I/II/IIIUnclearExtraarticular
      IMN, intramedullary nailing; AO, Arbeitsgemeinschaft für Osteosynthesefragen; R, reamed; LCP, locking compression plating; ETN, Expert Tibia Nail; N.A., not applicable; +percentage, number of fixed fibular fracture/total fracture.
      a 43-C1 in this study had minimally displaced extension into articular surface which was almost as same as 43-A.
      b All the 42-A cases were 4–11 cm proximal from the tibial plafond.
      The primary outcome measurements (Table 3) included the complication rate, the union time, the operation time and the hospital stays. The secondary outcome measurements included the functional score and the pain score. All the studies mentioned the malunion and the nonunion of fractures (13/13). The studies showed a higher malunion rate in the IMN group and three studies showed a higher nonunion rate in the IMN group. All but one literature mentioned the infection rate (12/13) and only three studies showed the inferiority of the IMN group. More than half of the included studies described the secondary surgery rate (7/13) and the union time (8/13). Six studies mentioned the implant removal rate and the operation time (6/13). Few studies mentioned hospital stays (3/13). Functional scores were assessed with three different criteria: Olerud and Molander Ankle Score (OMAS) [
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      ,
      • Mauffrey C.
      • McGuinness K.
      • Parsons N.
      • Achten J.
      • Costa M.L.
      A randomised pilot trial of locking plating fixation versus intramedullary nailing for extra-articular fractures of the distal tibia.
      ,
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      ,
      • Yang S.W.
      • Tzeng H.M.
      • Chou Y.J.
      • Teng H.P.
      • Liu H.H.
      • Wong C.Y.
      Treatment of distal tibial metaphyseal fractures: plating versus shortened intramedullary nailing.
      ,
      • Zhang C.
      • Jiang Y.
      • An Z.Q.
      Interlocking intramedullary nailing versus percutaneous plating in osteosynthesis of metaphyseal fractures of distal tibia.
      ] in five studies, American Orthopaedic Foot and Ankle score (AOFAS) [
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ] in one and Musculoskeletal Function Assessment (MFA) [
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ] in one (7/13 in total). All seven studies showed a higher functional score in the IMN group, and Mauffery et al. [
      • Mauffrey C.
      • McGuinness K.
      • Parsons N.
      • Achten J.
      • Costa M.L.
      A randomised pilot trial of locking plating fixation versus intramedullary nailing for extra-articular fractures of the distal tibia.
      ] also showed statistical difference (p < 0.05). In addition, four studies assessed pain, of which one assessed knee pain [
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ], while the other three assessed ankle pain [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ]. As a result, we used the standard mean difference (SMD) as the outcome measure of the functional scores and the pain scores.
      Table 3the details of outcomes of included studies.
      StudyMalunion (%)Nonunion (%)Infection (%)Secondary surgery rate (%)Implant removal rate (%)Time to union [M(SD)]Operation time [M(SD)]Hospital stays [M(SD)]Functional score [M(SD)]
      Of the functional score, Guo adopted AOFAS; Im, Yang, Mauffery, Li and Zhang adopted OMAS; Vallier adopted MFA.
      Pain score [M(SD)]
      Of the pain score, Janssen adopted anterior knee pain score; Feng adopted VAS pain score; Guo adopted the pain score of AOFAS; Vallier adopted the pain score of MFA.
      IMNPlateIMNPlateIMNPlateIMNPlateIMNPlateIMNPlateIMNPlateIMNPlateIMNPlateIMNPlate
      Guo
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      00007155259525917.717.681.2397.9N.A.N.A.86.183.97.58.5
      (2.9)(2.2)(11.43)(9.61)(8.16)(6.93)(4.05)(3.91)
      Im
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      12097323N.A.N.A.N.A.N.A.18207289N.A.N.A.88.588.3N.A.N.A.
      (13)(15)(15)(27.5)(1.76)(1.76)
      Janssen
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      5017008810075927521.419.31231079.89.5N.A.N.A.43.176.92
      (4.35)(4.97)(30)(33.75)(4)(2.75)(37.91)(14.76)
      Yang
      • Yang S.W.
      • Tzeng H.M.
      • Chou Y.J.
      • Teng H.P.
      • Liu H.H.
      • Wong C.Y.
      Treatment of distal tibial metaphyseal fractures: plating versus shortened intramedullary nailing.
      2370000N.A.N.A.N.A.N.A.22.627.8N.A.N.A.6.46.586.283.9N.A.N.A.
      (4.3)(7.6)(2)(1.6)(3.2)(7.1)
      Vallier
      • Vallier H.A.
      • Le T.T.
      • Bedi A.
      Radiographic and clinical comparisons of distal tibia shaft fractures (4 to 11 cm proximal to the plafond): plating versus intramedullary nailing.
      2957353301688N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.
      Vallier
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      251974561823910N.A.N.A.N.A.N.A.N.A.N.A.73720.350.31
      (17.25)(16.25)(0.22)(0.24)
      Mauffery
      • Mauffrey C.
      • McGuinness K.
      • Parsons N.
      • Achten J.
      • Costa M.L.
      A randomised pilot trial of locking plating fixation versus intramedullary nailing for extra-articular fractures of the distal tibia.
      8008258842833N.A.N.A.N.A.N.A.N.A.N.A.82.366.7N.A.N.A.
      (13.51)(13.07)
      Li
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      13400413N.A.N.A.N.A.N.A.21.323.176905.88.98987.6N.A.N.A.
      (3.5)(3.6)(16.6)(20.3)(2.1)(3.1)(7.1)(8.4)
      Seyhan
      • Seyhan M.
      • Unay K.
      • Sener N.
      Intramedullary nailing versus percutaneous locked plating of distal extra-articular tibial fractures: a retrospective study.
      16346017125683615.717.24N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.
      (3.92)(3.05)
      Zhang
      • Zhang C.
      • Jiang Y.
      • An Z.Q.
      Interlocking intramedullary nailing versus percutaneous plating in osteosynthesis of metaphyseal fractures of distal tibia.
      19000017N.A.N.A.N.A.N.A.18.59 (3.75)20 (3.96)82.22 (12.51)89.16 (14.12)N.A.N.A.82 (7)79 (7)N.A.N.A.
      Feng
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      230001411N.A.N.A.N.A.N.A.21.115.494100N.A.N.A.N.A.N.A.6.76.1
      (3)(2.9)(12)(14)(2.5)(2.6)
      Chen
      • Chen N.
      • He Q.Q.
      Clinical analysis for two fixation methods in distal tibiofibular fracture.
      00000040N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.
      Zhu
      • Zhu H.W.
      Interlocking intramedullary nail for distal tibial fracture.
      1801N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.N.A.
      IMN, intramedullary nailing; MIPO, minimally invasive plating osteosynthesis; N.A., not applicable; OMAS, olerud and molander functional ankle score; AOFAS, American Orthopaedic Foot and Ankle surgery scores; MFA, Musculoskeletal Function Assessment.
      a Of the functional score, Guo adopted AOFAS; Im, Yang, Mauffery, Li and Zhang adopted OMAS; Vallier adopted MFA.
      b Of the pain score, Janssen adopted anterior knee pain score; Feng adopted VAS pain score; Guo adopted the pain score of AOFAS; Vallier adopted the pain score of MFA.

      Subgroup analysis

      Subgroup analysis was done in our meta-analysis, which mainly focuses on the types of internal fixations such as the BS, the locking plate, the DLN and the reamed IMN which would affect the mechanical stability. The degree of injury of different reduction techniques, MIPO or non-MIPO, and fracture type made a difference. The time of weight bearing also influenced the recovery of the fracture. In addition, the quality, the study design and the ITT analysis were included in the subgroup analysis.

      Statistical analysis

      We converted all outcome measurements using Review Manager 5.1.3 software and Stata 11.0. We used relative risk (RR) for the dichotomous data and weighted mean difference (WMD) or standardised mean difference (SMD) for the continuous data. A chi-squared test on N − 1 degrees of freedom was used to calculate the statistical heterogeneity, with significance at 0.05. I2 (I2 = ((Q − df)/Q) × 100%) was used to calculate the percentage of the variability in effect estimates according to the heterogeneity. Q is the χ2 statistic and df is the degree of freedom. We considered I2 values of 25%, 50% and 75% as low, medium and high heterogeneity, respectively. A fixed-effects model was used if I2 < 50%; otherwise, we used the random-effects model. If substantial heterogeneities across studies (I2 > 50%) were detected in the index five main meta-analyses, we performed post hoc sensitivity analysis by omitting the outlier studies to determine the sources of heterogeneity. The outliers were detected as the studies in which the confidence interval of the estimated effect size did not overlap well with the pooled overall effect size [
      • Higgins J.P.
      • Thompson S.G.
      Quantifying heterogeneity in a meta-analysis.
      ]. For skewed distribution, if the sample size was <60, standard deviation (SD) = (upper limit − lower limit)/4. We also calculated SD = standard error (SE) × N1/2 if we could got SE related to Z score. In order to keep the consistent trend in the forest plot, we used the computational method that adjusted mean score = total score − mean score, and the SD did not change for several outcomes in the functional score and the pain score. The funnel plot [
      • Higgins J.P.T.
      • Green S.
      Cochrane Collaboration Cochrane handbook for systematic reviews of interventions.
      ] was used to assess publication bias. If there were asymmetrical plots, we used the trim and fill analysis to assess the stability [
      • Hayashino Y.
      • Noguchi Y.
      • Fukui T.
      Systematic evaluation and comparison of statistical tests for publication bias.
      ]. When allowed, the subgroup analyses were performed in isolation for DTF. We also used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to evaluate the quality of evidence by each outcome [
      • Phi L.
      • Ajaj R.
      • Ramchandani M.H.
      • Brant X.M.
      • Oluwadara O.
      • Polinovsky O.
      Expanding the Grading of Recommendations Assessment, Development, and Evaluation (Ex-GRADE) for Evidence-Based Clinical Recommendations: validation study.
      ].

      Results

      The literature search initially yielded 6620 relevant studies, from which 2391 redundant publications were excluded. According to our criteria of inclusion and exclusion, 4213 studies were excluded. In the remaining full texts, three studies had data duplication and only the newest one was included [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ]. One study carried another study further [
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      ] and we included both. Finally, 14 studies including five prospective trials [
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Randomized, prospective comparison of plating versus intramedullary nail fixation for distal tibia shaft fractures.
      ,
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ,
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      ,
      • Mauffrey C.
      • McGuinness K.
      • Parsons N.
      • Achten J.
      • Costa M.L.
      A randomised pilot trial of locking plating fixation versus intramedullary nailing for extra-articular fractures of the distal tibia.
      ] and 12 retrospective trials [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ,
      • Chen N.
      • He Q.Q.
      Clinical analysis for two fixation methods in distal tibiofibular fracture.
      ,
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ,
      • Li Y.
      • Liu L.
      • Tang X.
      • Pei F.
      • Wang G.
      • Fang Y.
      • et al.
      Comparison of low, multidirectional locked nailing and plating in the treatment of distal tibial metadiaphyseal fractures.
      ,
      • Vallier H.A.
      • Le T.T.
      • Bedi A.
      Radiographic and clinical comparisons of distal tibia shaft fractures (4 to 11 cm proximal to the plafond): plating versus intramedullary nailing.
      ,
      • Yang S.W.
      • Tzeng H.M.
      • Chou Y.J.
      • Teng H.P.
      • Liu H.H.
      • Wong C.Y.
      Treatment of distal tibial metaphyseal fractures: plating versus shortened intramedullary nailing.
      ,
      • Zhang C.
      • Jiang Y.
      • An Z.Q.
      Interlocking intramedullary nailing versus percutaneous plating in osteosynthesis of metaphyseal fractures of distal tibia.
      ,
      • Zhu H.W.
      Interlocking intramedullary nail for distal tibial fracture.
      ,
      • Seyhan M.
      • Unay K.
      • Sener N.
      Intramedullary nailing versus percutaneous locked plating of distal extra-articular tibial fractures: a retrospective study.
      ] with 842 participants were included (Fig. 1). The weighted kappa for the agreement on eligibility between reviewers was 0.84 (95% CI: 0.71–0.93). No publication bias was found in the funnel plot (Fig. 2).
      Figure thumbnail gr1
      Fig. 1A QUOROM flowchart illustrated the selection of studies included in our meta-analysis.
      Figure thumbnail gr2
      Fig. 2Funnel plot for total complication rate between IMN and plating showed no publication bias in visual. IMN, intramedullary nailing; RR, risk ratio.

      Complication rate

      IMN decreased the infection rate by 48% (N = 695, RR: 0.52 (0.30, 0.89); p = 0.02), but increased the malunion rate by 147% (N = 842, RR: 2.47 (1.58, 3.85); p < 0.0001) compared with plating. There was no significant difference in the total complication rate (N = 842, RR: 1.14 (0.75, 1.72); p = 0.53), the nonunion rate (N = 842, RR: 1.16 (0.51, 2.67); p = 0.72), the secondary surgery rate (N = 457, RR = 0.87 (0.52, 1.43); p = 0.57) and the implant removal rate (N = 411, RR = 0.82 (0.51, 1.31)) (Table 4). All the outcomes did not change if the studies with moderate to low quality were omitted.
      Table 4The statistical comparison in outcomes between IMN and plating.
      OutcomesFracture typeEvent (IMN/plating)Sample size (IMN/plating)Mean [CI]I2p
      1. RR
       Total complication rateDTF118/89443/3991.14 [0.75, 1.72]57%0.53
       Malunion rateDTF68/22443/3992.47 [1.58, 3.85]29%<0.0001
       Nonunion rateDTF13/9443/3991.16 [0.51, 2.67]0%0.72
       Infection rateDTF19/35369/3260.52 [0.30, 0.89]15%0.02
       Secondary surgery rateDTF73/75250/2070.87 [0.52, 1.43]67%0.57
       Implant removal rateDTF48/58225/1860.82 [0.51, 1.31]53%0.42
      2. WMD
       Time to unionDTFN.A.200/208−0.21 [−2.46, 2.05]88%0.86
       Operation timeDTFN.A.162/158−10.66 [−16.64, −4.68]65%0.0005
       Hospital staysDTFN.A.48/49−1.08 [−3.33, 1.17]79%0.35
      3. SMD
       Functional scoreDTFN.A.198/185−0.26 [−0.47, −0.06]0%0.01
       Pain scoreDTFN.A.123/1220.23 [−0.23, 0.70]67%0.33
      DTF, distal tibial fracture; IMN, intramedullary nailing; RR, relative risk; WMD, weighted mean difference; SMD, standardised mean difference; N.A., not applicable; RR > 1 or WMD > 0 or SMD > 0 means the results favouring plating, vice versa.
      We found medium heterogeneity (I2 = 57%) in the total complication rate. We conducted the subgroup analysis and found the origin of the heterogeneity. After the separation in the subgroup analysis of locking plate, the heterogeneity was significantly reduced (p = 0.04). We also found medium heterogeneity in the secondary surgery rate (I2 = 67%) and the implant removal rate (I2 = 52%). When excluding the data of Seyhan et al. [
      • Higgins J.P.
      • Thompson S.G.
      Quantifying heterogeneity in a meta-analysis.
      ], which included two different IMNs, the heterogeneity reduced to 37% (p = 0.007) and 16% (p = 0.04), respectively.

      Functional score and pain score

      IMN increased the functional score (N = 383, SMD: −0.26 (−0.47 to −0.06); p = 0.01) compared with plating. However, no difference was found in the pain score (N = 245, SMD: 0.23 (−0.23 to −0.70); p = 0.33). All the outcomes did not change if the studies with moderate-to-low quality were omitted. We found medium heterogeneity (I2 = 67%) in the pain score. We noted three studies [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ] that assessed the ankle pain except for the study by Janssen et al. [
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ] that assessed knee pain. The heterogeneity reduced to 22% after excluding the study by Janssen et al. (p = 0.01). All the outcomes did not change if the studies with moderate to low quality were omitted.

      Other data

      IMN decreased the operation time (N = 320, WMD = −10.66 (−16.64, −4.68); p = 0.0005) but had no influence on the time to union (N = 408, WMD: −0.21 (−2.46 to −2.05); p = 0.86) or the hospital stays (N = 97, WMD = −1.08 (−3.33, 1.17); p = 0.35). All the outcomes did not change if the studies with moderate to low quality were omitted. The high heterogeneity in the time to union (I2 = 88%) reduced to 42% (p < 0.00001) after excluding the study by Feng et al. [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ].

      Subgroup analysis

      IMN conferred more than twice the risk of malunion than plating. However, if the technique of either the BS or the DLN was adopted, the inferiority of IMN disappeared (RR of BS: 3.00 (0.34–26.76), RR of non-BS: 2.45 (1.55–3.85); RR of DLN: 3.00 (0.34–26.76) and RR of non-DLN: 2.33 (1.46, 3.71)) (Table 5). For DTF (Table 5), there was a reduced trend of PRT in the malunion rate for IMN (p = 0.13). MIPO also showed no statistical significance in the infection rate compared with IMN (RR: 0.61 (0.30–1.23)). However, no benefit of MIPO was found in the nonunion rate (p = 0.70).
      Table 5Subgroup analysis of the included studies between IMN and plating based on influential factors.
      FactorsGeneral complicationMalunion rateNonunion rateInfection rateSecondary operative rateFunctional scorePain score
      SubgroupRR (95% CI)SubgroupRR (95% CI)SubgroupRR (95% CI)SubgroupRR (95% CI)SubgroupRR (95% CI)SubgroupSMD (95% CI)SubgroupSMD (95% CI)
      Design
      All the prospective studies were with high quality according to 12-items, while retrospective studies were all with moderate or low quality, yes=high quality according to 12-items scoring system; no=moderate and low quality.
      Pro (4)1.00 (0.68, 1.47)Pro (4)1.74 (0.87, 3.47)Pro (4)1.10 (0.30, 4.06)Pro (4)0.54 (0.25, 1.13)Pro (3)0.81 (0.54, 1.22)Pro (4)−0.23 (−0.48, 0.01)Pro (2)−0.04 (−0.45, 0.38)
      Ret (9)1.30 (0.69, 2.45)Ret (9)3.01 (1.68, 5.39)Ret (9)1.44 (0.61, 3.40)Ret (8)0.50 (0.23, 1.10)Ret (4)0.97 (0.36, 2.60)Ret (3)−0.33 (−0.68, 0.03)Ret (2)0.66 (−0.30, 1.62)
      p = 0.49p = 0.23p = 0.91p = 0.90p = 0.75p = 0.68p = 0.19
      Quality
      All the prospective studies were with high quality according to 12-items, while retrospective studies were all with moderate or low quality, yes=high quality according to 12-items scoring system; no=moderate and low quality.
      Yes (4)1.00 (0.68, 1.47)Yes (4)1.74 (0.87, 3.47)Pro (4)1.10 (0.30, 4.06)Pro (4)0.54 (0.25, 1.13)Pro (3)0.81 (0.54, 1.22)Yes (4)−0.23 (−0.48, 0.01)Yes (2)−0.04 (−0.45, 0.38)
      No (9)1.37 (0.87, 2.14)No (9)3.01 (1.68, 5.39)Ret (9)1.44 (0.61, 3.40)Ret (8)0.50 (0.23, 1.10)Ret (4)0.97 (0.36, 2.60)No (3)−0.33 (−0.68, 0.03)No (2)0.66 (−0.30, 1.62)
      p = 0.49p = 0.23p = 0.91p = 0.90p = 0.75p = 0.68p = 0.19
      ITTYes (1)1.29 (0.74, 2.24)Yes (1)1.33 (0.63, 2.80)Yes (1)1.71 (0.33, 8.95)Yes (1)0.86 (0.18, 4.05)Yes (1)0.78 (0.36, 1.67)Yes (1)−0.66 (−0.48, 0.36)Yes (1)0.17 (−0.25, 0.60)
      No (12)1.12 (0.69, 1.80)No (12)3.18 (1.81, 5.56)No (12)1.02 (0.39, 2.68)No (11)0.48 (0.27, 0.87)No (6)0.87 (0.48, 1.57)No (6)−0.32 (−0.55, −0.09)No (3)0.31 (−0.42,1.04)
      p = 0.71p = 0.07p = 0.59p = 0.50p = 0.83p = 0.28p = 0.75
      ETNYes (1)1.00 (0.28, 3.52)Yes (1)3.00 (0.34,26.76)Yes (1)N.A.Yes (1)0.33 (0.04, 2.97)N.AN.A.Yes (1)−0.18 (−0.76, 0.40)Yes (0)N.A.
      No (11)1.27 (0.81, 1.99)No (11)2.33 (1.46, 3.71)No (11)N.A.No (10)0.62 (0.35, 1.10)N.AN.A.No (6)−0.27 (−0.49, −0.06)No (4)N.A.
      p = 0.73p = 0.82N.A.p = 0.59N.A.p = 0.76N.A.
      Blocking ScrewYes (1)1.00 (0.28, 3.52)Yes (1)3.00 (0.34,26.76)Yes (1)N.A.Yes (1)0.33 (0.04, 2.97)N.AN.A.Yes (1)−0.18 (−0.76, 0.40)Yes (0)N.A.
      No (12)1.15 (0.74, 1.79)No (12)2.45 (1.55, 3.85)No (12)N.A.No (11)0.53 (0.31, 0.94)N.AN.A.No (6)−0.27 (−0.49, −0.06)No (4)N.A.
      p = 0.84p = 0.86N.A.p = 0.68N.A.p = 0.76N.A.
      Locking plateYes (8)0.79 (0.46, 1.36)Yes (8)2.26 (1.10, 4.65)Yes (8)0.85 (0.25, 2.92)Yes (7)0.36 (0.17, 0.75)Yes (3)0.60 (0.17, 2.16)Yes (4)−0.23 (−0.49, 0.04)Yes (2)−0.04 (−0.51, 0.42)
      No (5)1.69 (1.05, 2.72)No (5)2.60 (1.48, 4.57)No (5)1.49 (0.48, 4.67)No (5)0.87 (0.38, 2.00)No (4)1.10 (0.63, 1.92)No (3)−0.31 (−0.63, 0.00)No (2)0.62 (−0.39, 1.63)
      p = 0.04p = 0.77p = 0.51p = 0.12p = 0.24p = 0.68p = 0.24
      MIPOYes (7)1.08 (0.53, 2.21)Yes (7)2.04 (1.23, 3.39)Yes (7)1.30 (0.47, 3.60)Yes (6)0.61 (0.31, 1.18)Yes (4)0.80 (0.41, 1.53)Yes (3)−0.17 (−0.44, 0.09)Yes (3)0.03 (−0.27, 0.33)
      No (6)1.17 (0.74, 1.85)No (6)4.43 (1.68, 11.65)No (6)0.91 (0.22, 3.86)No (6)0.38 (0.15, 0.98)No (3)0.84 (0.16, 4.33)No (4)−0.38 (−0.69, −0.07)No (1)1.22 (0.33, 2.10)
      p = 0.86p = 0.16p = 0.70p = 0.43p = 0.95p = 0.31p = 0.01
      Fibular fixation
      Yes=cases with intact fibula or fibular fixation/total cases >50%, no=cases with intact fibula or fibular fixation/total cases <50%.
      Yes (7)1.27 (0.73, 2.23)Yes (7)5.15 (2.31,11.51)Yes (7)1.06 (0.27, 4.19)Yes (7)0.30 (0.14, 0.68)N.A.N.A.Yes(1)−0.31 (−0.73, 0.12)Yes (2)0.66 (−0.30, 1.62)
      No (3)1.48 (0.55, 3.98)No (3)2.21 (1.15, 4.24)No (3)1.99 (0.54, 7.32)No (3)1.18 (0.34, 4.07)N.A.N.A.No (6)−0.03 (−0.28, 0.21)No (1)0.17 (−0.25, 0.60)
      p = 0.80p = 0.11p = 0.51p = 0.07N.A.p = 0.27p = 0.36
      PRT for IMNYes (8)1.11 (0.64, 1.93)Yes (8)2.05 (1.26, 3.34)Yes (8)1.12 (0.44, 2.89)Yes (7)0.58 (0.30, 1.13)Yes (6)0.84 (0.50, 1.41)Yes (4)−0.30 (−0.56, −0.05)Yes (3)0.27 (−0.38, 0.92)
      No (5)1.15 (0.59, 2.23)No (5)5.61 (1.71, 18.46)No (5)1.32 (0.24, 7.40)No (5)0.41 (0.16, 1.05)No (1)2.54 (0.11, 59.23)No (3)−0.19 (−0.53, 0.15)No (1)0.23 (−0.33, 0.79)
      p = 0.94p = 0.13p = 0.87p = 0.54p = 0.50p = 0.59p = 0.93
      Reamed IMNYes (9)1.01 (0.60, 1.69)Yes (9)2.17 (1.34, 3.52)Yes (9)1.31 (0.54, 3.14)Yes (8)0.38 (0.20, 0.75)Yes (6)0.94 (0.58, 1.53)Yes (4)−0.20 (−0.44, 0.03)Yes (3)0.27 (−0.38, 0.92)
      No (4)1.50 (0.77, 2.95)No (4)4.73 (1.43,15.65)No (4)0.33 (0.01, 7.45)No (4)1.11 (0.41, 2.98)No (1)0.20 (0.03, 1.47)No (3)−0.45 (−0.86, −0.04)No (1)0.23 (−0.33, 0.79)
      p = 0.36p = 0.24p = 0.41p = 0.08p = 0.14p = 0.30p = 0.93
      IMN, intramedullary nailing; ITT, intention-to-treat; ETN, expert tibia nail; MIPO, minimally invasive plating osteosynthesis; PRT, percutaneous reduction technique; Pro, prospective; Ret, retrospective.
      a All the prospective studies were with high quality according to 12-items, while retrospective studies were all with moderate or low quality, yes = high quality according to 12-items scoring system; no = moderate and low quality.
      b Yes = cases with intact fibula or fibular fixation/total cases >50%, no = cases with intact fibula or fibular fixation/total cases <50%.

      GRADE analysis

      Our GRADE analysis showed the comprehensively moderate quality in all the outcomes (Table 6). The most important reasons for the reduced level of evidence were inadequate blinding and lack of concealed allocation. Small sample size also decreased the evidence grade of the pain score, the union time and the functional score. Furthermore, the heterogeneity in the pain score and the union time had a negative effect on the quality.
      Table 6GRADE evidence of comparison between IMN and plating in efficacy and safety for treatment of TMF.
      OutcomeSummary of findingsQuality assessment
      Sample size (IMN/plating)RR/WMD/SMD [95% CI]Limitations
      Inadequate blinding, lack of allocation concealed may cause limitations.
      Inconsistency
      Inconsistent report of outcomes and significant heterogeneity, but we used subgroup analysis to explain them.
      IndirectnessImprecision
      A study with wide confidence interval around the estimate of the effect, or included sample less than 400, it would cause imprecision.
      Others
      “Other” included publication bias and upgraded quality of evidence (large effect, plausible residual confounding and dose-response gradient).
      Quality
      Functional score198/185−0.26 [−0.47, −0.06]SeriousNo seriousSeriousSeriousNoneModerate
      Pain score123/1220.23 [−0.23, 0.70]SeriousSeriousNo seriousSeriousNoneModerate
      Time to union200/208−0.21 [−2.46, 2.05]SeriousSeriousNo seriousNo seriousNoneModerate
      Malunion rate443/3992.47 [1.58, 3.85]SeriousNo seriousNo seriousNo seriousNoneModerate
      Infection rate369/3260.52 [0.30, 0.89]SeriousNo seriousNo seriousNo seriousNoneModerate
      Nonunion rate443/3991.16 [0.51, 2.67]SeriousNo seriousNo seriousNo seriousNoneModerate
      Secondary surgery rate250/2070.87 [0.52, 1.43]SeriousNo seriousNo seriousNo seriousNoneModerate
      Implant removal rate225/1860.82 [0.51, 1.31]SeriousNo seriousNo seriousNo seriousNoneModerate
      Total complication rate443/3991.14 [0.75, 1.72]SeriousSeriousNo seriousNo seriousNoneModerate
      Operation time162/158−10.66 [−16.64, −4.68]SeriousSeriousNo seriousSeriousNoneModerate
      Hospital stay48/49−1.08 [−3.33, 1.17]SeriousSeriousNo seriousSeriousNoneModerate
      GRADE, Grading of Recommendations Assessment, Development and Evaluation; RR, risk ratio; WMD, weighted mean difference.
      a Inadequate blinding, lack of allocation concealed may cause limitations.
      b Inconsistent report of outcomes and significant heterogeneity, but we used subgroup analysis to explain them.
      c A study with wide confidence interval around the estimate of the effect, or included sample less than 400, it would cause imprecision.
      d “Other” included publication bias and upgraded quality of evidence (large effect, plausible residual confounding and dose-response gradient).

      Discussion

      Plating was always accepted as the first choice for DTF until the late 20th century when IMN gained satisfactory results and wide popularity with improvement in techniques [
      • Hiesterman T.G.
      • Shafiq B.X.
      • Cole P.A.
      Intramedullary nailing of extra-articular proximal tibia fractures.
      ,
      • Bedi A.
      • Le T.T.
      • Karunakar M.A.
      Surgical treatment of nonarticular distal tibia fractures.
      ,
      • Bhandari M.
      • Audige L.
      • Ellis T.
      • Hanson B.
      Operative treatment of extra-articular proximal tibial fractures.
      ,
      • Zelle B.A.
      • Bhandari M.
      • Espiritu M.
      • Koval K.J.
      • Zlowodzki M.
      Treatment of distal tibia fractures without articular involvement: a systematic review of 1125 fractures.
      ]. In this systematic review and meta-analysis, we asked: (1) which fixation is better with regard to the clinical function and the complications and (2) which modifying factors affect the comparative effect between both techniques.
      To the best of our knowledge, the present meta-analysis is the first to comprise all the available comparative controlled evidence and comprehensively investigate the difference in function, pain and complications between IMN and plating for DTF. As the previous systematic reviews only included retrospective observational studies, their validity was limited by imbalances between groups, lack of independent assessment, failure for blinding of outcome measurements and inadequate follow-up [
      • Zelle B.A.
      • Bhandari M.
      • Espiritu M.
      • Koval K.J.
      • Zlowodzki M.
      Treatment of distal tibia fractures without articular involvement: a systematic review of 1125 fractures.
      ]. Recently, a systematic review [
      • Iqbal H.J.
      • Pidikiti P.
      Treatment of distal tibia metaphyseal fractures; plating versus intramedullary nailing: a systematic review of recent evidence.
      ] focussing on complication rate was done by including two randomised controlled trials (RCTs) [
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ,
      • Im G.I.
      • Tae S.K.
      Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plating and screws fixation.
      ] and four retrospective comparative studies [
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ,
      • Vallier H.A.
      • Le T.T.
      • Bedi A.
      Radiographic and clinical comparisons of distal tibia shaft fractures (4 to 11 cm proximal to the plafond): plating versus intramedullary nailing.
      ,
      • Yang S.W.
      • Tzeng H.M.
      • Chou Y.J.
      • Teng H.P.
      • Liu H.H.
      • Wong C.Y.
      Treatment of distal tibial metaphyseal fractures: plating versus shortened intramedullary nailing.
      ,
      • Joveniaux P.
      • Ohl X.
      • Harisboure A.
      • Berrichi A.
      • Labatut L.
      • Simon P.
      • et al.
      Distal tibia fractures: management and complications of 101 cases.
      ]. All the studies were also included in our analysis except for one study, which did not meet our inclusion criteria, involved serious intra-articular fractures and lacked concrete data of complication rate or functional score in the IMN group [
      • Joveniaux P.
      • Ohl X.
      • Harisboure A.
      • Berrichi A.
      • Labatut L.
      • Simon P.
      • et al.
      Distal tibia fractures: management and complications of 101 cases.
      ]. This systematic review gave exactly the same results in complication rate, but the lack of adequate sample size limited the level of evidence. The present sample size in our analysis is larger with elevated quality of GRADE evidence compared with the previous reviews. Furthermore, our analysis has no language restriction so that the publication bias is reduced as much as possible.
      We acknowledge limitations such as: (1) some might argue against the inclusion of the retrospective studies because of their inherent risk of bias. However, most of the patient data were obtained from these studies and, despite methodological limitations, ignoring this source of data might underpower the analysis, raise the risk of false negative error and influence the accuracy of our findings. Most of them balanced the demographic parameters between two groups, which limited the opportunity of selection bias. Furthermore, the results of the subgroup analysis remained unchanged after excluding these retrospective studies. (2) The unavailable raw data of the early studies, such as weight bearing and fibular fixation, made part of our subgroup analyses impossible. In addition, the different scoring criteria for function and pain across the studies might lead to the heterogeneity. These drawbacks necessitated a uniform and standardised format of follow-up in future. (3) The heterogeneity was significant in the outcomes of the total complication rate, the pain score and the time to union. The sensitivity analysis and the subgroup analysis were done to find the origins. (4) The small sample size in the subgroup analysis reduced the precision of the pooled estimates and the ability to detect the statistical significance of some variables, that is, the BS, the DLN and the PRTs in the evaluation of the malunion rate and MIPO in the evaluation of the infection rate. More RCTs would be warranted to clarify them.
      One of the most significant results of our analysis is that IMN had higher functional score and comparable pain score of DTF compared with plating. However, we were unable to explain the clinical implications of the statistical difference because SMD was merely an absolute value without a unit or a cut-off reference. Of the included four studies in the pain comparison, three assessed the ankle [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ], while one assessed the knee [
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ]. The present data, indicating the similar rates of hardware removal and the ankle pain of both modalities, might confirm the possible relationship between ankle pain and hardware irritation [
      • Feng Y.Z.
      • Hong J.J.
      • Peng L.
      • Shui X.L.
      • Tang J.
      • Chen L.W.
      • et al.
      Comparison of two minimally invasive internal fixed methods for the treatment of distal tibio-fibula.
      ,
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Guo J.J.
      • Tang N.
      • Yang H.L.
      • Tang T.S.
      A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.
      ]. In addition, the present analysis failed to show the correlation between knee pain and leg function [
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ,
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ]. Vallier et al. [
      • Vallier H.A.
      • Cureton B.A.
      • Patterson B.M.
      Factors influencing functional outcomes after distal tibia shaft fractures.
      ] found a trend of more knee pain with IMN, whereas 95% of the patients returned to work without activity limitation. Further, the more severe knee pain with IMN reported by Janssen et al. [
      • Janssen K.W.
      • Biert J.
      • van Kampen A.
      Treatment of distal tibial fractures: plating versus nail: a retrospective outcome analysis of matched pairs of patients.
      ] mainly occurred during kneeling or squatting, which did not influence the excellent knee function.
      Our data showed that the malunion rate of IMN was considerably higher than in the case of plating, which was in agreement with the biomechanical data [
      • Zlowodzki M.
      • Williamson S.
      • Cole P.A.
      • Zardiackas L.D.
      • Kregor P.J.
      Biomechanical evaluation of the less invasive stabilization system, angled blade plate, and retrograde intramedullary nail for the internal fixation of distal femur fractures.
      ] and previous systematic review [
      • Iqbal H.J.
      • Pidikiti P.
      Treatment of distal tibia metaphyseal fractures; plating versus intramedullary nailing: a systematic review of recent evidence.
      ]. Interestingly, when the studies with combination of IMN and either the BS or the DLN were analysed separately in the subgroup analysis, the inferiority of IMN disappeared. In addition, there was a trend of reduced malunion rate of IMN when the PRTs were adopted. In a multicentre case series of TMFs treated with the DLN, Attal et al. [
      • Attal R.
      • Hansen M.
      • Kirjavainen M.
      • Bail H.
      • Hammer T.O.
      • Rosenberger R.
      • et al.
      A multicentre case series of tibia fractures treated with the Expert Tibia Nail (ETN).
      ] found that the malalignment rate was only 5.4% for DTF. Nork et al. [
      • Nork S.E.
      • Schwartz A.K.
      • Agel J.
      • Holt S.K.
      • Schrick J.L.
      • Winquist R.A.
      Intramedullary nailing of distal metaphyseal tibial fractures.
      ,
      • Nork S.E.
      • Barei D.P.
      • Schildhauer T.A.
      • Agel J.
      • Holt S.K.
      • Schrick J.L.
      • et al.
      Intramedullary nailing of proximal quarter tibial fractures.
      ] treated TMFs using reamed IMN combined with the percutaneous locking techniques, which showed acceptable alignment in 92% of the patients. All the clinical and biomechanical evidence supported the potential advantages of the BS, the DLN and the PRTs.
      With regard to DTF, our results demonstrated the excellence of IMN over plating in the infection rate, which one previous systematic review failed [
      • Zelle B.A.
      • Bhandari M.
      • Espiritu M.
      • Koval K.J.
      • Zlowodzki M.
      Treatment of distal tibia fractures without articular involvement: a systematic review of 1125 fractures.
      ] but another gave the same result [
      • Iqbal H.J.
      • Pidikiti P.
      Treatment of distal tibia metaphyseal fractures; plating versus intramedullary nailing: a systematic review of recent evidence.
      ]. It turned out that the previous result was potentially biased by the higher percentage of the open fractures in the IMN group. Besides, MIPO had an infection rate similar to IMN in the subgroup analysis, which was consistent with the cadaveric data [
      • Borrelli Jr., J.
      • Prickett W.
      • Song E.
      • Becker D.
      • Ricci W.
      Extraosseous blood supply of the tibia and the effects of different plating techniques: a human cadaveric study.
      ]. An adequately powered RCT with long-term follow-up is necessary to verify it.
      The present analysis and the previous systematic reviews [
      • Zelle B.A.
      • Bhandari M.
      • Espiritu M.
      • Koval K.J.
      • Zlowodzki M.
      Treatment of distal tibia fractures without articular involvement: a systematic review of 1125 fractures.
      ,
      • Iqbal H.J.
      • Pidikiti P.
      Treatment of distal tibia metaphyseal fractures; plating versus intramedullary nailing: a systematic review of recent evidence.
      ] both suggested a similar nonunion rate between IMN and plating, which might be attributed to the minimal exposure, the precise reduction and the rigid fixation. Despite its theoretical advantage in local vascularity [
      • Borrelli Jr., J.
      • Prickett W.
      • Song E.
      • Becker D.
      • Ricci W.
      Extraosseous blood supply of the tibia and the effects of different plating techniques: a human cadaveric study.
      ], we did not detect the statistical significance of MIPO in lowering the nonunion risk. More comparative data would be needed to address this hypothesis.

      Conclusion

      IMN and plating appear to share a similar nonunion rate, secondary surgery rate and implant removal rate for DTF. Specifically for DTF, IMN may be preferential, given its higher function score, lower risk of infection and comparable pain score and time to union. Plating could be an alternative when BS, DLN and PRT are unavailable. However, with the biases in our meta-analysis, all these viewpoints will ultimately require a rigorous and adequately powered RCT to prove.

      Conflict of interest

      Xun-Zi Cai is currently receiving grants from Zhejiang Provincial Natural Science Foundation of China (Y2110239), National Natural Science Foundation of China (81101345) and Zhejiang Key Programme Science and Technology (2011C13033). For the remaining authors none were declared.

      Acknowledgements

      We thank the corresponding authors of included studies, especially Vallier HA, for their sincere assistance in obtaining and verifying data. The project was funded by Zhejiang Provincial Natural Science Foundation of China (Y2110239), National Natural Science Foundation of China (81101345), and Zhejiang Key Programme Science and Technology (2011C13033).

      Appendix A. Supplementary data

      The following are the supplementary data to this article:

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