Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- stem subsidence
- Status
- Recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.
Detailed Description
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem. Patients will be randomized a few days before the operation. At the time of surgery, the surgeon will use the relevant implant. Patients will be followed up for 5 years after surgery. The main outcome criteria is the stem subsidence measured radiographically with a dedicated software.
Investigators
Dr David BIAU
Professor
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
Eligibility Criteria
Inclusion Criteria
- •hip osteoarthritis requiring a total hip replacement
- •\>18 years old
- •agrees to participate
Exclusion Criteria
- •total hip replacement not indicated
- •general anesthesia contraindicated
- •previous surgery on the ipsilateral femur
- •follow-up not possible
Outcomes
Primary Outcomes
stem subsidence
Time Frame: 2 years postop
stem subsidence will be measured using the EBRA (Ein-Bild-Rontgen-analyse) software on postoperative antero-posterior radiographs (5 xrays from day one to year 2)
Secondary Outcomes
- Intraoperative surgeon satisfaction(intraoperative)