Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate

Brief Summary

Official Title: “A Prospective Randomised Study of Unstable Trochanteric Femur Fractures Treated With Dynamic Hip Screw With and Without a Trochanter Support Plate”

Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. In a prospective randomised study we wish to test the hypothesis that the TSP does not give any additional stability to the fracture treated with the DHS.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2013

Interventions Used in this Clinical Trial

  • Procedure: Addition of TSP to DHS
    • All patients operated with DHS. Of these two groups. One operated with TSP and one without.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: -TSP
    • Patients operated without TSP
  • Active Comparator: +TSP
    • Patients operated with TSP

Outcome Measures for this Clinical Trial

Primary Measures

  • Fracture movement postoperatively
    • Time Frame: One year
      Safety Issue?: No

Secondary Measures

  • Reoperation
    • Time Frame: One year
      Safety Issue?: Yes
  • Pain postoperatively
    • Time Frame: one year
      Safety Issue?: No
  • Hip function postoperatively
    • Time Frame: one year
      Safety Issue?: No
  • Fracture healing
    • Time Frame: one year
      Safety Issue?: Yes
  • complications postoperatively
    • Time Frame: one year
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5)
  • (can include; Patients with cognitive problems (ie. dementia etc)

Exclusion Criteria

  • Patients with pathological fractures
  • Multitrauma patients
  • Patients not able to walk before the fracture
  • Under 19 years old.
  • Patients with fractures needing other treatments than gliding hip screws
  • Reverse oblique fractures.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • St. Olavs Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • James Haddon, MD, Principal Investigator, St. Olavs Hospital


Babst R, Renner N, Biedermann M, Rosso R, Heberer M, Harder F, Regazzoni P. Clinical results using the trochanter stabilizing plate (TSP): the modular extension of the dynamic hip screw (DHS) for internal fixation of selected unstable intertrochanteric fractures. J Orthop Trauma. 1998 Aug;12(6):392-9.

Madsen JE, Naess L, Aune AK, Alho A, Ekeland A, Strømsøe K. Dynamic hip screw with trochanteric stabilizing plate in the treatment of unstable proximal femoral fractures: a comparative study with the Gamma nail and compression hip screw. J Orthop Trauma. 1998 May;12(4):241-8.


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