• Anne Marie Nyholm, Henrik Palm, Henrik Malchau, Anders Troelsen, and Kirill Gromov.
• Clinical Orthopaedic Research Hvidovre, Department of Orthopaedics, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark. Electronic address: rienyholm@gmail.com.
• Injury. 2016 Mar 1; 47 (3): 586-94.

IntroductionEvaluation of the long-term performance of implants used in trauma surgery relies on post-marked clinical studies since no registry based implant assessment exists. The purpose of this study was to evaluate the evidence of performance of implants currently used for treating proximal femoral fractures (PFF) in Denmark.MethodPubMed was searched for clinical studies on primary PFF with follow-up ≥12 months, reporting implant-related failure and evaluating one of following: DHS, CHS, HipLoc, Gamma3, IMHS, InterTan, PFN, PFNA or PTN.LimitsEnglish language and publication date after 1st of January 1990.ResultsAll studies were evidence level II or III. 30 publications for SHS were found: 13 of CHS, 15 of DHS and 2 of HipLoc. In total CHS was evaluated in 1110 patients (900 prospectively), DHS in 2486 (567 prospectively) and HipLoc in 251 (all prospectively). Fifty-four publications for nails were found: 13 of Gamma3, 7 of IMHS, 5 of InterTan, 10 of PFN, 24 of PFNA and 0 of PTN. In total Gamma3 was evaluated in 1088 patients (829 prospectively), IMHS in 1543 (210 prospectively), InterTan in 595 (585 prospectively), PFN in 716 (557 prospectively), PFNA in 1762 (1018 prospectively) and PTN in 0.ConclusionsThe clinical evidence behind the current implants used for proximal femoral fractures is weak considering the number of implants used worldwide. Sporadic evaluation is not sufficient to identify long term problems. A systematic post market surveillance of implants used for fracture treatment, preferable by a national register, is necessary in the future.Copyright © 2016 Elsevier Ltd. All rights reserved.

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