A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

Study Overview
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Brief Summary
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This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.

Detailed Description
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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.

Official Title
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A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

Conditions
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Arthritis, Avascular Necrosis

Intervention / Treatment
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* Procedure: Anterolateral approach
* Procedure: Posterior approach
* Device: ReCap Total Hip Resurfacing
* Device: ReCap Total Hip Resurfacing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 61 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System. | Procedure: Anterolateral approach<br>* 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.<br>Device: ReCap Total Hip Resurfacing<br>* This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.<br>|
| Active Comparator: 2<br>This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System. | Procedure: Posterior approach<br>* 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.<br>Device: ReCap Total Hip Resurfacing<br>* This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RSA |  | 1 week, 3 months, 1 year, 2 years, 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |