A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zimmer Biomet
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- RSA
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 29 Years to 61 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
Intervention: Anterolateral approach (Procedure)
1
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
Intervention: ReCap Total Hip Resurfacing (Device)
2
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
Intervention: Posterior approach (Procedure)
2
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
Intervention: ReCap Total Hip Resurfacing (Device)
Outcomes
Primary Outcomes
RSA
Time Frame: 1 week, 3 months, 1 year, 2 years, 5 years
Secondary Outcomes
- Conventional X-ray(1 week)
- Gait Analysis(1 week, 3 months, 1 year)
- Microdialysis(1 week)
- DEXA scan(Pre-operatively, 1 week, 1 year, 2 years)
- Harris Hip Score(Pre-operatively, 1 week, 6 weeks, 3 months, 1 year)