Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Femoral Neck Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Internal fixation

Closed reduction and internal fixation with two parallel screws (Olmed)

Group Type OTHER

Internal fixation

Intervention Type PROCEDURE

Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)

Bipolar hemiarthroplasty

Hemiarthroplasty with Charnley/ Hastings prosthesis

Group Type OTHER

Bipolar hemiarthroplasty

Intervention Type PROCEDURE

Lateral approach. FWB.

Interventions

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Bipolar hemiarthroplasty

Lateral approach. FWB.

Intervention Type PROCEDURE

Internal fixation

Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)

Intervention Type PROCEDURE

Other Intervention Names

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Charnley/Hastings Olmed (DePuy)

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No