A Randomized Study of Approaches in Total Hip Arthroplasty

Mayo Clinic

Status: Completed

Conditions: Total Hip Replacement

Treatments: Procedure: Direct Anterior Approach; Procedure: Mini-Posterior Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT01613508

12-001341

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Direct Anterior Approach

Active Comparator group

Description:

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.

Treatment:

Procedure: Direct Anterior Approach

Mini-Posterior Approach

Active Comparator group

Description:

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.

Treatment:

Procedure: Mini-Posterior Approach