Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches

NCT ID: NCT01807494

Last Updated: 2015-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2023-02-28

Brief Summary

Hip replacement is a common surgical procedure performed to relieve the pain and disability. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the hip with metal and plastic components shaped to allow continued motion of the hip. Surgeons may perform this operation in several different ways. The purpose of this study is to compare two different methods of performing total hip replacement. The investigators hypothesize that subjects treated with the anterior approached may show improved function during the early postoperative period, but that no differences in pain or function will be present after the first postoperative year.

In this study, patients that have elected to have hip replacement and consented to participate in the study will be randomized to have his or her hip replaced using one of two surgical techniques. Subjects will be randomized to be implanted using either an anterior or posterior approach. With the anterior approach, the study surgeon will use an incision that is on the front of the hip, and with the posterior approach, the incision will be more on the backside of your hip. The study surgeon has done more than 300 total hip replacements with both of these techniques.

A baseline assessment will be conducted before hip replacement surgery that includes x-rays, functional tasks like getting up from a chair and stepping down a step, and three questionnaires about the hip, the subject's general health, and how well the subject is able to function. Also, subjects will be required to return to the clinic at several time points after surgery for follow-up visits. Follow-up visits will include hip assessments and questionnaires, as well as follow-up hip x-rays. The follow-up visits will be 6 weeks, 3 months, 1 year, 2 years, 5 years, 7 years, and 10 years after hip replacement surgery. These follow-up visits are part of the study surgeon's normal routine for hip replacement patients, and are not extra visits as a part of this study.

Conditions

Osteoarthritis; Avascular Necrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Posterior approach

Subjects in this group will total hip replacement performed with a posterior surgical approach and total hip replacement components.

Group Type: ACTIVE_COMPARATOR

Total hip replacement components

Intervention Type: DEVICE

All patients will receive the same implants

Anterior Approach

Subjects in this group will have total hip replacement performed with a direct anterior surgical approach and total hip replacement components.

Group Type: ACTIVE_COMPARATOR

Total hip replacement components

Intervention Type: DEVICE

All patients will receive the same implants

Interventions

Total hip replacement components

All patients will receive the same implants

Intervention Type: DEVICE

Other Intervention Names

Femoral component will be the Biomet Taperloc Complete and the acetabular component will be the Biomet Ringloc+

Eligibility Criteria

Inclusion Criteria

• Between ages of 18 and 85
• End stage hip joint degeneration
• Has elected to undergo primary total hip arthroplasty

Exclusion Criteria

• Undergoing revision arthroplasty
• Inflammatory or rheumatoid arthritis
• Patients with confounding medical conditions that are not expected to survive for the duration of follow-up (10 years)
• Body Mass Index greater than 40 kg/m2
• Age < 18 or > than 85
• Previous ipsilateral hip surgery including arthroscopic procedures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomet Orthopedics, LLC

INDUSTRY

Sponsor Role: collaborator

New Lexington Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian P Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

Lexington Clinic

Locations

Lexington Clinic

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

LCO.2012.05

Identifier Type: -

Identifier Source: org_study_id