A Randomized Study of Approaches in Total Hip Arthroplasty
This trial is active, not recruiting.
|Condition||total hip replacement|
|Treatments||direct anterior approach, mini-posterior approach|
|Start date||January 2013|
|End date||July 2017|
|Trial size||142 participants|
|Trial identifier||NCT01613508, 12-001341|
The primary aim of the study is to compare the results of an established, successful procedure, which is total hip arthroplasty through a mini-posterior approach to a less studied - increasingly popular procedure, which is total hip replacement through the direct anterior approach utilizing the orthopedic table.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Activity monitors will be worn
time frame: Baseline to 1 year
Male or female participants at least 20 years old.
Inclusion Criteria 1. Male or Female patients between 20 and 100 with unilateral osteoarthritis (DJD) who are surgical candidates for total hip arthroplasty 2. Study participants must be able to give informed consent. Exclusion Criteria 1. Significant proximal femoral deformity (post SCFE, Perthes, DDH), acetabular dysplasia (ANY CROWE), inflammatory arthritis, septic arthritis, osteomyelitis, prior infection of hip joint, significant leg length discrepancy (> 4cm), osteoporosis, arthrodesis of the affected hip. 2. The presence of infections, highly communicable diseases, e.g. AIDS, active tuberculosis, venereal disease, hepatitis. 3. Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing. 4. Presence of previous prosthetic hip replacement device (any type). 5. Active Metastatic disease 6. Active major Psychiatric illness 7. Active Drug or alcohol abuse 8. BMI > 40. 9. Patients that are known to be pregnant 10. Actively failing contralateral hip replacement.
|Official title||A Randomized Clinical Trial of Direct Anterior Approach and Mini-Posterior Approach Total Hip Arthroplasty|
|Principal investigator||Michael Taunton, MD|
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