A Randomized Study of Approaches in Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Clinical Trial of Direct Anterior Approach and Mini-Posterior Approach Total Hip Arthroplasty

Conditions
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Total Hip Replacement

Intervention / Treatment
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* Procedure: Direct Anterior Approach
* Procedure: Mini-Posterior Approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male or Female patients between 20 and 100 with unilateral osteoarthritis (DJD) who are surgical candidates for total hip arthroplasty Study participants must be able to give informed consent. Exclusion Criteria 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. The presence of infections, highly communicable diseases, e.g. AIDS, active tuberculosis, venereal disease, hepatitis. Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing. Presence of previous prosthetic hip replacement device (any type). Active Metastatic disease Active major Psychiatric illness Active Drug or alcohol abuse BMI > 40. Patients that are known to be pregnant Actively failing contralateral hip replacement.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct Anterior Approach<br>An oblique incision is made over the anterior margin of the tensor muscle. The fascia of the tensor muscle is identified and incised. The muscle is swept digitally laterally and a retractor is placed over the superior aspect of the femoral neck. The hip capsule is then incised and retracted. | Procedure: Direct Anterior Approach<br> <br> |
| Active Comparator: Mini-Posterior Approach<br>The surgical approach involved a 7 to 9.5 cm incision along the posterior aspect of the femur starting at the tip of the greater trochanter and proceeding distally. The fascia of the gluteus maximus was split, and blunt dissection revealed the underlying abductor and external rotator musculature. The external rotators an the hip capsule were incised and preserved as one layer, with an attempt being made to preserve the insertion of the quadratus femoris on the femur. The hip was dislocated posteriorly and the femoral neck was cut in accordance with the preoperative plan. | Procedure: Mini-Posterior Approach<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity monitors will be worn | 3 monitoring sensors will be worn by the subject. | Baseline to 1 year |