A Randomized Study of Approaches in Total Hip Arthroplasty

NCT01613508 | Completed

• 1 other identifier: 12-001341
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

• Activity monitors will be worn

  3 monitoring sensors will be worn by the subject.

  Baseline to 1 year

Study Arms (2)

Direct Anterior Approach

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.

Procedure: Direct Anterior Approach

Mini-Posterior 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.

Procedure: Mini-Posterior Approach

Interventions

Direct Anterior Approach PROCEDURE

Direct Anterior Approach

Mini-Posterior Approach PROCEDURE

Mini-Posterior Approach

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female patients between 20 and 100 with unilateral osteoarthritis (DJD) who are surgical candidates for total hip arthroplasty
• Study participants must be able to give informed consent.

You may not qualify if:

• 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.
• The presence of infections, highly communicable diseases, e.g. AIDS, active tuberculosis, venereal disease, hepatitis.
• Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
• Presence of previous prosthetic hip replacement device (any type).
• Active Metastatic disease
• Active major Psychiatric illness
• Active Drug or alcohol abuse
• BMI \> 40.
• Patients that are known to be pregnant
• Actively failing contralateral hip replacement.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Michael Taunton, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 7, 2012
• Study Start: January 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: February 27, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

US (1)