Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up

Not Applicable

Completed

• Conditions: Femoral Neck Fractures
• Interventions: Procedure: Internal fixation; Procedure: Bipolar hemiarthroplasty

• Registration Number: NCT00764153
• 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, and better short term clinical results with arthroplasty, but knowledge about long term results is lacking.

Detailed Description

Patients were included from 2002-2004. Two years follow up was finished by 2006. Patients with displaced intracapsular femoral neck fractures were included and 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: 2002-10
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-10-01
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-22
• Last Update Posted: 2014-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Arm && Interventions

Group	Intervention	Description
Internal fixation	Internal fixation	Closed reduction and internal fixation with two parallel screws (Olmed)
Bipolar hemiarthroplasty	Bipolar hemiarthroplasty	Hemiarthroplasty with Charnley/ Hastings prosthesis

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	5-6 years

Secondary Outcome Measures

Name	Time	Method
Eq-5d	5-6 years
Reoperations and complications	5-6 years
Barthel Index	5-6 years