title: Lacking evidence for performance of implants used for proximal femoral fractures - A systematic review.
abstract: BACKGROUND
  Evaluation 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.
  
  
  METHODS
  PubMed 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.
  
  
  CONCLUSIONS
  English language and publication date after 1st of January 1990.
  
  
  RESULTS
  All 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Clinical Orthopaedic Research Hvidovre, Department of Orthopaedics, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark. Electronic address: rienyholm@gmail.com.
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Nyholm
authors.affiliation: Clinical Orthopaedic Research Hvidovre, Department of Orthopaedics, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark.
authors.forename: Henrik
authors.initials: H
authors.lastname: Palm
authors.affiliation: Orthopedic Department, Massachusetts General Hospital, 55 Fruit Street, GRJ 1126, Boston, MA, United States.
authors.forename: Henrik
authors.initials: H
authors.lastname: Malchau
authors.affiliation: Clinical Orthopaedic Research Hvidovre, Department of Orthopaedics, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark.
authors.forename: Anders
authors.initials: A
authors.lastname: Troelsen
authors.affiliation: Clinical Orthopaedic Research Hvidovre, Department of Orthopaedics, Copenhagen University Hospital Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark.
authors.forename: Kirill
authors.initials: K
authors.lastname: Gromov
mesh_terms: D001858:Bone Nails; D001863:Bone Screws; D003718:Denmark / Q000453:epidemiology; D019317:Evidence-Based Medicine; D005594:Fracture Fixation, Intramedullary / Q000295:instrumentation* / Q000379:methods; D006620:Hip Fractures / Q000453:epidemiology / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D011474:Prosthesis Design; D012042:Registries; D016896:Treatment Outcome
keywords: Hip fracture; Implant failure; Implant survival; Proximal femoral fracture; Reoperation; Trochanteric fracture