This trial is active, not recruiting.

Condition total hip replacement
Treatments direct anterior approach, mini-posterior approach
Sponsor Mayo Clinic
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
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.
direct anterior approach
(Active Comparator)
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.
mini-posterior approach

Primary Outcomes

Activity monitors will be worn
time frame: Baseline to 1 year

Eligibility Criteria

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.

Additional Information

Official title A Randomized Clinical Trial of Direct Anterior Approach and Mini-Posterior Approach Total Hip Arthroplasty
Principal investigator Michael Taunton, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.