Arthritis, Avascular Necrosis
Conditions
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.
Interventions
PROCEDUREAnterolateral approach
The anterolateral approach is performed with the patient positioned on the side. The blood supply to the femoral neck from the medial circumflex artery is regarded preserved by this surgical method.
PROCEDUREPosterior approach
The posterior approach is performed with the patient positioned on the side. The medial circumflex artery is cut at the lower border of the short external rotators risking a compromised blood supply to the femoral head.
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
Sponsors
Aarhus University Hospital
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
29 Years to 61 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RSA | 1 week, 3 months, 1 year, 2 years, 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Harris Hip Score | Pre-operatively, 1 week, 6 weeks, 3 months, 1 year |
| Microdialysis | 1 week |
| Conventional X-ray | 1 week |
| Gait Analysis | 1 week, 3 months, 1 year |
| DEXA scan | Pre-operatively, 1 week, 1 year, 2 years |
Countries
Denmark
Outcome results
None listed