A Randomized Study of Approaches in Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01613508
Recruitment Status : Active, not recruiting
First Posted : June 7, 2012
Last Update Posted : January 24, 2017
Information provided by (Responsible Party):
Michael J. Taunton, M.D., Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Total Hip Replacement Procedure: Direct Anterior Approach Procedure: Mini-Posterior Approach Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Direct Anterior Approach and Mini-Posterior Approach Total Hip Arthroplasty
Study Start Date : January 2013
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Activity monitors will be worn [ Time Frame: Baseline to 1 year ]
    3 monitoring sensors will be worn by the subject.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01613508

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

Responsible Party: Michael J. Taunton, M.D., PI, Mayo Clinic Identifier: NCT01613508     History of Changes
Other Study ID Numbers: 12-001341
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017