A Randomized Study of Approaches in Total Hip Arthroplasty
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.
Total Hip Replacement
Procedure: Direct Anterior Approach
Procedure: Mini-Posterior Approach
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Clinical Trial of Direct Anterior Approach and Mini-Posterior Approach Total Hip Arthroplasty|
- Activity monitors will be worn [ Time Frame: Baseline to 1 year ] [ Designated as safety issue: No ]3 monitoring sensors will be worn by the subject.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Direct Anterior Approach
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|
Active Comparator: Mini-Posterior Approach
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613508
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Michael Taunton, MD||Mayo Clinic|