Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches

October 5, 2015 updated by: New Lexington Clinic

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.

Study Overview

Status

Unknown

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Lexington Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Posterior approach
Subjects in this group will total hip replacement performed with a posterior surgical approach and total hip replacement components.
All patients will receive the same implants
Other Names:
  • Femoral component will be the Biomet Taperloc Complete and the acetabular component will be the Biomet Ringloc+
Active Comparator: Anterior Approach
Subjects in this group will have total hip replacement performed with a direct anterior surgical approach and total hip replacement components.
All patients will receive the same implants
Other Names:
  • Femoral component will be the Biomet Taperloc Complete and the acetabular component will be the Biomet Ringloc+

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
Testing to objectively quantify subject function when rising from a chair and descending stairs
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
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)
Collected during the hospital stay (usually 1 to 5 days)
Operative time
Time Frame: Intra-operative
Intra-operative
Number of patients that require blood transfusion
Time Frame: Intra-operative
Intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Christian P Christensen, MD, Lexington Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on Total hip replacement components

Subscribe