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 2012

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

References

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.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00626470