Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures

Study Overview
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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, but there is no consensus about which procedure that gives best functional results.

Detailed Description
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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: Two parallel screws (Olmed). 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.

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

Conditions
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Femoral Neck Fractures

Intervention / Treatment
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* Procedure: Bipolar hemiarthroplasty (Charnley/Hastings)
* Procedure: Internal fixation with two parallel screws (Olmed)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bipolar hemiarthroplasty (Charnley/Hastings)|nan|
|Procedure: Internal fixation with two parallel screws (Olmed)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  |  | 
| Re-operations |  |  | 
| Complications |  |  | 
| Morbidity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Displaced Femoral Neck Fractures, Treatment, Function, Pain, Quality of life, Complications, Reoperations, Internal Fixation, Hemiarthroplasty, Activities of Daily Living