Abstract
Purpose
This prospective pilot study investigated the safety and efficacy of a novel radiolucent
intramedullary nail (IMN) made of Carbon-Fibre-Reinforced Polyaryl-Ether-Ether-Ketone
(CFR-PEEK) for humeral shaft fracture fixation.
Study Design
A prospective, single-arm, four-centre study.
Patients and Methods
A total of 46 patients with 46 humeral fractures classified as 12 A-B were treated
with a novel CFR-PEEK IMN and followed for 12 months.
Results
Most of the patients (65%) were female; the mean age was 65 ± 17 years. The average
operating time was 66.75 ± 19.84 minutes and X-ray exposure was 104.11 ± 98.01 seconds.
All patients postoperatively reported selflimiting shoulder pain and three patients
developed iatrogenic transient radial palsy. Two patients required repositioning of
the implant. No implant-related complications were observed. Radiological consolidation
was achieved in all 43 patients who completed the 12-month follow-up.
Conclusions
The CFR-PEEK IMN is user-friendly and safe. Its bone-matching elastic modulus seems
to contribute to its clinical efficacy. This, together with compatibility with modern
imaging techniques, can be considered a further evolution of IMN designed to stabilise
humeral shaft fractures.
Keywords
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 accessOne-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:
Subscribe to InjuryAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Humeral nailing revisited.Injury. 2008; 39: 1319-1328
- The advantages of titanium alloy over stainless steel plates for the internal fixation of fractures. An experimental study in dogs.Jxs Bone Joint Surg Br. 1981; 63-B: 427-484
- Polyetheretherketone – cytotoxicity and mutagenicity in vitro.Biomaterials. 2002; 23: 1749-1759
- Polyetheretherketone as a biomaterial for spinal applications.Biomaterials. 2006; 27: 324-334
- Carbon fiber reinforced PEEK optima – a composite material biomechanical properties and wear/debris characteristics of CF-PEEK composites for orthopedic trauma implants.J Mech Behav Biomed Mater. 2013; 17: 221-228
- Use of carbon-fiber-reinforced composite implants in orthopedic surgery.Orthopedics. 2014; 37: 825-830
- Vertebral body replacement with a bioglass-polyurethane composite in spine metastases – clinical, radiological and biomechanical results.Eur Spine J. 2000; 9: 437-444
- The prospect of carbon fiber implants in radiotherapy.J Appl Clin Med Phys. 2012; 13: 3821
- The effects of nail rigidity on fracture healing in rats with osteoporosis.Acta Orthop. 2009; 80: 135-138
- Effects of nail rigidity on fracture healing. Strength and mineralisation in rat femoral bone.Arch Orthop Trauma Surg. 1998; 118: 7-13
- The impact of residual angulation on patient reported functional outcome scores after non-operative treatment for humeral fractures.Injury. 2016; 47: 914-918
- Proximal humeral fractures: non-operative treatment versus intramedullary nailing in 2–3–4 part fractures.Injury. 2016; 47: S14-S19
- Internal fixation of shaft humerus fractures by dynamic compression plate or interlocking intramedullary nail: a prospective, randomised study.Strategies Trauma Limb Reconstr. 2014; 9: 133-140
- Compression plating versus intramedullary nailing of humeral shaft fractures: a meta-analysis.Acta Orthop. 2006; 77: 279-284
- Complications after interlocking intramedullary nailing of humeral shaft fractures.Injury. 2014; 45: S9-S15
- Principles of biomechanics and biomaterials in orthopaedic surgery.BoneJoint Surg Am. 2011; 93: 207-212
- Finite element analysis of a femoral retrograde intramedullary nail subject to gait loading.Med Eng Phys. 2004; 26: 93-108
- Biomechanical assessment of composite versus metallic intramedullary nailing system in femoral shaft fractures: A finite element study.Clin Biomech. 2014; 29: 803-810
- Loading of healing bone, fibrous tissue, and muscle: implications for orthopaedic practice.Am Acad Orthop Surg. 1999; 7: 291-299
- Basic orthopaedic biomechanics and mechano-biology.Lippincot. 3rd. Lippincott Williams & Wilkins, Philadelphia2005
- Effect of loading and fracture motions on diaphyseal tibial fractures.J Orthop Res. 1996; 14: 80-84
- Effect of unreamed, limited reamed, and standard reamed intramedullary nailing on cortical bone porosity and new bone formation.J Ortho Trauma. 2001; 15: 18-27
- Fatigue fracture of the interlocking nail in the treatment of fractures of the distal part of the femoral shaft.J Bone Joint Surg Am. 1987; 69: 1391-1399
- The invisible nail: a technique report of treatment of a pathological humerus fracture with a radiolucent intramedullary nail.Injury. 2011; 42: 424-426
Article info
Identification
Copyright
© 2017 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
