Overview

This trial is active, not recruiting.

Conditions osteoarthritis, avascular necrosis
Treatment total hip replacement components
Sponsor New Lexington Clinic
Collaborator Biomet Orthopedics, LLC
Start date November 2012
End date February 2023
Trial size 60 participants
Trial identifier NCT01807494, LCO.2012.05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Subjects in this group will total hip replacement performed with a posterior surgical approach and total hip replacement components.
total hip replacement components Femoral component will be the Biomet Taperloc Complete and the acetabular component will be the Biomet Ringloc+
All patients will receive the same implants
(Active Comparator)
Subjects in this group will have total hip replacement performed with a direct anterior surgical approach and total hip replacement components.
total hip replacement components Femoral component will be the Biomet Taperloc Complete and the acetabular component will be the Biomet Ringloc+
All patients will receive the same implants

Primary Outcomes

Measure
Time to discontinued use of an assistive ambulatory device (cane or walker)
time frame: 6 week postoperative follow-up

Secondary Outcomes

Measure
modified Harris Hip Score
time frame: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
SF-12
time frame: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
Lower Extremity Functional Score
time frame: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
Functional force testing
time frame: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
implant survivorship
time frame: 1-, 2-, 5-, 7-, and 10-year follow-ups
Length of hospital stay
time frame: Collected during the hospital stay (usually 1 to 5 days)
Operative time
time frame: Intra-operative
Number of patients that require blood transfusion
time frame: Intra-operative

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches
Principal investigator Christian P Christensen, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by New Lexington Clinic.