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Clinical Trials/NCT00464230
NCT00464230
Completed
Phase 4

The Management of Intracapsular Fractures of the Proximal Femur. A Prospective, Randomized Trial of Two Parallel Screws and Hemiarthroplasty

Ullevaal University Hospital1 site in 1 country220 target enrollmentSeptember 2002

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Femoral Neck Fractures
Sponsor
Ullevaal University Hospital
Enrollment
220
Locations
1
Primary Endpoint
Harris Hip Score at 4, 12 and 24 months
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any patient, and the risk of disability, increased dependence and death is substantial. The main treatment options for displaced femoral neck fractures are internal fixation and arthroplasty. It is established that there are more complications and reoperations after internal fixation, but there is no consensus about which procedure that gives best functional results.

Detailed Description

We plan to include patients with displaced intracapsular femoral neck fractures. The patients will be randomized by means of closed numbered envelopes to operation groups: 1. Two parallel screws (Olmed). 2. Hemiarthroplasty with Charnley/ Hastings prosthesis. A priori one would expect that there would be less morbidity and mortality with the less extensive and quicker operation with parallel screw and that a faster and better rehabilitation would be achieved with hemiarthroplasty.

Registry
clinicaltrials.gov
Start Date
September 2002
End Date
March 2006
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ullevaal University Hospital

Eligibility Criteria

Inclusion Criteria

  • Displaced femoral neck fracture
  • Age 60 or above
  • Able to walk (any aids allowed)

Exclusion Criteria

  • Anesthesiologically unfit for arthroplasty surgery
  • Previous symptomatic hip pathology (i.e. arthritis)
  • Pathological fracture
  • Delay of more than 96 hours from injury to treatment
  • Not living in hospital area

Outcomes

Primary Outcomes

Harris Hip Score at 4, 12 and 24 months

Barthel ADL Index at 4, 12 and 24 months

Eq-5d (Euroqol) at 4, 12 and 24 months

Secondary Outcomes

  • Mortality
  • Re-operations
  • Complications
  • Morbidity

Study Sites (1)

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