Hemi Artificial Hipjoint Versus Total Artificial Hipjoint

Study Overview
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Brief Summary
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This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint replacement.

Detailed Description
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Seventy patients over seventy years who are admitted in our hip fracture department with the indication for hemi joint replacement therapy, due to a Garden 3-4 femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt are randomized to either hemialloplastik or total joint replacement. The patients are followed for 24 mouths with X-ray Stereo Photogrammetric Analysis (RSA) radiographs and clinical examinations.

Official Title
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Clinical and RSA Comparison of Hemi Versus Total Hip Arthroplasty After Displaced Femoral Neck Fracture. A Randomized Double-Blind Study

Conditions
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Optimized Treatment

Intervention / Treatment
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* Procedure: Hemi (hemialloplastik)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 70 years, admitted two our hip-fracture department with a 3-4 Garden femoral neck fracture or a fracture Garden 1-2 with over 20-degree posterior tilt. Preoperative New Mobility Score ≥ 6th Patients must be able to speak and understand Danish. Patients must be able to give informed consent and be cognitively intact (Hindsøe score ≥ 6). Patients should be expected to be able to implement the postoperative controls. Patients should not be medically ill: ASA-score ≤ 3rd

Ages Eligible for Study
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Minimum Age: 70 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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Surgery<br>RSA study on hemi | Procedure: Hemi (hemialloplastik)<br>* THA vs hemi<br>* Other names: BFX: Biomet CE-number: 00520;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic and clinical | Migration / rotation: Migration is measured by X-ray Stereo Photogrammetric Analysis (RSA). Clinical assessment: The patient is assessed clinically using the WOMAC and EQ-5D. | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical | Implant Placement: Mobilisation: Patient mobilization level before the fracture is assessed by the New Mobility Score.Under hospital assessed patients' ability to time with current time instrument daily using the Cumulated ambulation score (CAS). Bleeding: Perioperative bleeding set in operation description from start to suture the incision closed. Hgb is measured as standard on the third day in all patients in the hip fracture unit. In addition, registered the need for blood transfusions in the first four postoperative days. | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip-fracture, RSA