Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck

Study Overview
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Brief Summary
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The primary aim of this study was to determine the Harris hip score as an evaluation of hip function, in mentally competent elderly patients (>65 years old) treated with either THR or IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare the rate of reoperations and complications between the two groups.

Official Title
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Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck. A Randomized, Controlled Trial With a Seventeen Year Follow-up

Conditions
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Femoral Neck Fracture

Intervention / Treatment
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* Procedure: Internal fixation
* Procedure: Total hip arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute displaced femoral neck fracture Garden III or IV, Age over 65 years, Admission from their own home, No concurrent joint disease or previous fracture in the lower extremities, Healthy or controlled medical conditions without significant systemic effects (ASA 1-2), Harris hip score of 100 Acceptance from the patient to participate in the study.

Ages Eligible for Study
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Minimum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Internal fixation<br>Displaced femoral neck fracture treated with internal fixation using two parallel cannulated screws. | Procedure: Internal fixation<br>* Two cannulated screws are placed under x-ray guidance<br>|
| Active Comparator: Total hip replacement<br>Displaced femoral neck fracture treated with total hip replacement through a posterior approach. | Procedure: Total hip arthroplasty<br>* A total hip arthroplasty is performed through a standard posterior approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris hip score | HHS index score of 0 indicates the worst possible function of the hip and a value of 100 indicates full function. | 17 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperations and complications | IF group: nonunion, osteonecrosis, deep infection or fracture in the vicinity of the screws. Protruding screws or extraction of the screws when the fracture was healed was not defined as a complication. THR group: radiographic signs of loosening of the femoral- or acetabular component, dislocation, periprosthetic fracture or deep infection | 17 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femoral neck fracture, total hip arthroplasty, internal fixation