[Trial of device that is not approved or cleared by the U.S. FDA]
This trial is active, not recruiting.
|Conditions||arthritis, avascular necrosis|
|Treatments||anterolateral approach, posterior approach, recap total hip resurfacing|
|Sponsor||Biomet U.K. Ltd.|
|Start date||September 2008|
|End date||July 2013|
|Trial size||49 participants|
|Trial identifier||NCT00750984, BMETEU.CR.EU9|
This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.
|Intervention model||parallel assignment|
time frame: 1 week, 3 months, 1 year, 2 years, 5 years
Harris Hip Score
time frame: Pre-operatively, 1 week, 6 weeks, 3 months, 1 year
time frame: 1 week
time frame: 1 week
time frame: 1 week, 3 months, 1 year
time frame: Pre-operatively, 1 week, 1 year, 2 years
Male or female participants from 29 years up to 61 years old.
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
|Official title||A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing|
|Principal investigator||Thomas Pryno, MD|
|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.|
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