A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Arthritis
- Sponsor
- Zimmer Biomet
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- RSA
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.
Detailed Description
Theoretical considerations of RECAP procedures through anterolateral trochanteric osteotomy: * Less bone resection, less complicated revision surgery. * Reduced stress shielding of the femur. * Lower incidence of hip dislocations. * Walking function improved by change in mobilisation regime and operative technique. * Risk of femoral neck fracture is reduced by preoperative measurement of bone density. * Risk of avascular necrosis of the femoral head is reduced with the anterolateral approach preserving femoral head blood supply and preventing later failure of the implant.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Primary hip OA
- •Secondary hip OA due to mild and moderate acetabular dysplasia
- •Sufficient bone quality for cementless acetabular component
- •Suited for resurfacing of the femoral head (pre- and intraoperatively assessed)
- •\>29 years
- •\<61 years
Exclusion Criteria
- •Neuromuscular or vascular diseases in affected leg
- •Patients found intra-operatively to be unsuited for a cementless acetabular component or cementing of the femoral component
- •Need of NSAID post-operatively
- •Fracture sequelae
- •Females at risk of pregnancy (no safe contraceptives)
- •Severe hip dysplasia
- •Sequelae from hip disease in childhood
- •Medicine with large effect on bone density (K-vitamin antagonists, loop-diuretic)
- •Alcoholism (females \> 14 units per week, males \> 21 units per week) AVN
- •Osteoporosis
Outcomes
Primary Outcomes
RSA
Time Frame: 1 week, 3 months, 1 year, 2 years, 5 years
Secondary Outcomes
- Microdialysis(1 week)
- DEXA scan(Pre-operatively, 1 week, 1 year, 2 years)
- Conventional X-ray(1 week)
- Gait Analysis(1 week, 3 months, 1 year)
- Harris Hip Score(Pre-operatively, 1 week, 6 weeks, 3 months, 1 year)