Research Article|Articles in Press

The statistical fragility of the distal fibula fracture literature: A systematic review of randomized controlled trials



      The purpose of this study was to apply both the fragility index (FI) and fragility quotient (FQ) to evaluate the degree of statistical fragility in the distal fibular fracture (DFF) literature. We hypothesized that the dichotomous outcomes within the DFF literature are statistically fragile.


      We performed a PubMed search for distal fibular fractures clinical trials from 2000 to 2022 reporting dichotomous outcomes. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ.


      Of the 1158 articles screened, 23 met the search criteria, with six RCTs included for analysis. Forty-five outcome events with 5 significant (p < 0.05) outcomes and 40 nonsignificant (p ≥ 0.05) outcomes were identified. The overall FI and FQ was 5 (IQR 4–6) and 0.089 (IQR 0.061–0.107), respectively.


      The randomized controlled trials in the peer-reviewed distal fibular fracture literature may not be as robust as previously thought, as incorporating statistical analyses solely on a P value threshold is misleading. Standardized reporting of the P value, FI and FQ can help the clinician reliably draw conclusions based on the fragility of outcome measures.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Injury
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Court-Brown C.M.
        • Caesar B
        Epidemiology of adult fractures: a review.
        Injury. 2006; 37: 691-697
        • Elsoe R.
        • Ostgaard S.E.
        • Larsen P.
        Population-based epidemiology of 9767 ankle fractures.
        Foot Ankle Surg. 2018; 24: 34-39
        • Canton G.
        • Sborgia A.
        • Maritan G.
        • Fattori R.
        • Roman F.
        • Tomic M.
        • et al.
        Fibula fractures management.
        World J Orthop. 2021; 12: 254-269
        • LAUGE-HANSEN N
        Ligamentous ankle fractures; diagnosis and treatment.
        Acta Chir Scand. 1949; 97: 544-550
        • Russo A.
        • Reginelli A.
        • Zappia M.
        • Rossi C.
        • Fabozzi O.
        • Cerrato M.
        • et al.
        Ankle fracture: radiographic approach according to the Lauge-Hansen classification.
        Musculoskelet Surg. 2013; 97
        • Briet J.P.
        • Hietbrink F.
        • Smeeing D.P.
        • Dijkgraaf M.G.W.
        • Verleisdonk E.J.
        • Houwert R.M.
        Ankle fracture classification: an innovative system for describing ankle fractures.
        J Foot Ankle Surg. 2019; 58: 492-496
        • da Fonseca LL
        • IG Nunes
        • Nogueira R.R.
        • Martins G.E.V.
        • Mesencio A.C.
        • Kobata S.I
        Reproducibility of the Lauge-Hansen, Danis-Weber, and AO classifications for ankle fractures.
        Rev Bras Ortop (Sao Paulo). 2018; 53: 101-106
        • Lampridis V.
        • Gougoulias N.
        • Sakellariou A.
        Stability in ankle fractures: diagnosis and treatment.
        EFORT Open Rev. 2018; 3: 294-303
        • Lesic A.
        • Bumbasirevic M.
        Ankle fractures.
        Curr Orthop. 2004; 18: 232-244
        • Smith G.
        The isolated lateral malleolar fracture: where are we and how did we get here?.
        surg. 2013; 11: 6-9
        • Michelson J.D.
        • Magid D.
        • Ney D.R.
        • Fishman E.K.
        Examination of the pathologic anatomy of ankle fractures.
        Journal of Trauma - Injury, Infection and Critical Care. 1992; 32: 65-70
        • Harper M.C.
        The short oblique fracture of the distal fibula without medial injury: an assessment of displacement.
        Foot Ankle Int. 1995; 16: 181-186
        • van den Bekerom M.P.J.
        • van Dijk C.N.
        Is fibular fracture displacement consistent with tibiotalar displacement?.
        Clin Orthop Relat Res. 2010; 468: 969-974
        • Huang Z.
        • Liu L.
        • Tu C.
        • Zhang H.
        • Fang Y.
        • Yang T.
        • et al.
        Comparison of three plate system for lateral malleolar fixation.
        BMC Musculoskelet Disord. 2014; 15
        • Minihane K.P.
        • Lee C.
        • Ahn C.
        • Zhang L.Q.
        • Merk B.R.
        Comparison of lateral locking plate and antiglide plate for fixation of distal fibular fractures in osteoporotic bone: a biomechanical study.
        J Orthop Trauma. 2006; 20: 562-566
        • Knutsen A.R.
        • Sangiorgio S.N.
        • Liu C.
        • Zhou S.
        • Warganich T.
        • Fleming J.
        • et al.
        Distal fibula fracture fixation: biomechanical evaluation of three different fixation implants.
        Foot and Ankle Surgery. 2016; 22: 278-285
        • Herrera-Pérez M.
        • Gutiérrez-Morales M.J.
        • Guerra-Ferraz A.
        • Pais-Brito J.L.
        • Boluda-Mengod J.
        • Garcés G.L.
        Locking versus non-locking one-third tubular plates for treating osteoporotic distal fibula fractures: a comparative study.
        Injury. 2017; 48: S60-S65
        • Miller A.G.
        • Margules A.
        • Raikin S.M.
        Risk factors for wound complications after ankle fracture surgery.
        J Bone Joint Surg. 2012; 94: 2047-2052
        • SooHoo N.F.
        • Krenek L.
        • Eagan M.J.
        • Gurbani B.
        • Ko C.Y.
        • Zingmond D.S.
        Complication rates following open reduction and internal fixation of ankle fractures.
        J Bone Joint Surg. 2009; 91: 1042-1049
        • Checketts J.X.
        • Scott J.T.
        • Meyer C.
        • Horn J.
        • Jones J.
        • Vassar M.
        The robustness of trials that guide evidence-based orthopaedic surgery.
        J Bone Joint Surg - Am Vol. 2018; 100: E85
        • Ioannidis J.P.A.
        Contradicted and initially stronger effects in highly cited clinical research.
        J Am Med Assoc. 2005; 294: 218-228
        • Pocock S.J.
        Current issues in the design and interpretation of clinical trials.
        Br Med J (Clin Res Ed). 1985; 290: 39
        • Sterne J.A.C.
        • Smith G.D.
        • Cox D.R.
        Sifting the evidence—what's wrong with significance tests?.
        BMJ. 2001; 322: 226
        • Feinstein A.R.
        The unit fragility index: an additional appraisal of “statistical significance” for a contrast of two proportions.
        J Clin Epidemiol. 1990; 43: 201-209
        • Matics T.J.
        • Khan N.
        • Jani P.
        • Kane J.M
        Clinical medicine the fragility index in a cohort of pediatric randomized controlled trials.
        J Clin Med. 2017; 6
        • Chavalarias D.
        • Wallach J.D.
        • Li A.H.T.
        • Ioannidis J.P.A.
        Evolution of reporting P values in the biomedical literature, 1990-2015.
        JAMA. 2016; 315: 1141-1148
        • Shochet L.R.
        • Kerr P.G.
        • Polkinghorne K.R.
        The fragility of significant results underscores the need of larger randomized controlled trials in nephrology.
        Kidney Int. 2017; 92: 1469-1475
        • Shen C.
        • Shamsudeen I.
        • Farrokhyar F.
        • Sabri K.
        Fragility of results in ophthalmology randomized controlled trials: a systematic review.
        Ophthalmology. 2018; 125: 642-648
        • Ahmed W.
        • Fowler R.A.
        • McCredie V.A.
        Does sample size matter when interpreting the fragility index?.
        Crit Care Med. 2016; 44: e1142-e1143
        • Megafu M.
        • Megafu E.
        The fragility of statistical findings in distal radius fractures: a systematic review of randomized controlled trials.
        Injury. 2022;
        • Fackler N.P.
        • Ehlers C.B.
        • Callan K.T.
        • Amirhekmat A.
        • Smith E.J.
        • Parisien R.L.
        • et al.
        Statistical fragility of single-row versus double-row anchoring for rotator cuff repair: a systematic review of comparative studies.
        Orthop J Sports Med. 2022; 1023259671221093390
        • Parisien R.L.
        • Trofa D.P.
        • O'Connor M.
        • Knapp B.
        • Curry E.J.
        • Tornetta P.
        • et al.
        The fragility of significance in the hip arthroscopy literature: a systematic review.
        JB JS Open Access. 2021; 6
        • Parisien R.L.
        • Dashe J.
        • Cronin P.K.
        • Bhandari M.
        • Tornetta P.
        Statistical significance in trauma research: too unstable to trust?.
        J Orthop Trauma. 2019; 33: E466-E470