Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures

Phase 4

Completed

• Conditions: Femoral Neck Fractures

• Registration Number: NCT00464230
• Lead Sponsor: Ullevaal University Hospital

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.

Study Timeline

• Study Start: 2002-09
• Study Completion: 2006-03
• Status Verified: 2007-04
• Study First Submitted: 2007-04-20
• Study First Submitted QC: 2007-04-20
• Study First Posted: 2007-04-23
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mortality
Re-operations
Complications
Morbidity

Trial Locations

Locations (1)

Orthopedic Center, Ulleval University Hospital; 🇳🇴 Oslo, Norway