Clinical and RSA Comparison of Hemi Versus Total Hip Arthroplasty After Displaced Femoral Neck Fracture. A Randomized Double-Blind Study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Optimized Treatment
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Radiographic and clinical
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a Randomized Controlled Trial study comparing hemialloplastik versus total joint replacement.
Detailed Description
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.
Investigators
Jakob Klit
MD
Hvidovre University Hospital
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Radiographic and clinical
Time Frame: Five years
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.
Secondary Outcomes
- Clinical(Five years)