A Randomized Study of Approaches in Total Hip Arthroplasty

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01613508
First received: June 5, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Total Hip Replacement
Procedure: Direct Anterior Approach
Procedure: Mini-Posterior Approach

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 142
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613508

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michael Taunton, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Michael Taunton, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01613508     History of Changes
Other Study ID Numbers: 12-001341
Study First Received: June 5, 2012
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 01, 2014