Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by New Lexington Clinic
Sponsor:
Collaborator:
Biomet Orthopedics, LLC
Information provided by (Responsible Party):
New Lexington Clinic
ClinicalTrials.gov Identifier:
NCT01807494
First received: March 4, 2013
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Osteoarthritis
Avascular Necrosis
Device: Total hip replacement components

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches

Resource links provided by NLM:


Further study details as provided by New Lexington Clinic:

Primary Outcome Measures:
  • Time to discontinued use of an assistive ambulatory device (cane or walker) [ Time Frame: 6 week postoperative follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Testing to objectively quantify subject function when rising from a chair and descending stairs

  • implant survivorship [ Time Frame: 1-, 2-, 5-, 7-, and 10-year follow-ups ] [ Designated as safety issue: Yes ]
  • Length of hospital stay [ Time Frame: Collected during the hospital stay (usually 1 to 5 days) ] [ Designated as safety issue: No ]
  • Operative time [ Time Frame: Intra-operative ] [ Designated as safety issue: Yes ]
  • Number of patients that require blood transfusion [ Time Frame: Intra-operative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: February 2023
Estimated Primary Completion Date: February 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Posterior approach
Subjects in this group will total hip replacement performed with a posterior surgical approach and total hip replacement components.
Device: Total hip replacement components
All patients will receive the same implants
Other Name: 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.
Device: Total hip replacement components
All patients will receive the same implants
Other Name: Femoral component will be the Biomet Taperloc Complete and the acetabular component will be the Biomet Ringloc+

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807494

Contacts
Contact: Cale A. Jacobs, PhD 859-258-8238 cjaco@lexclin.com

Locations
United States, Kentucky
Lexington Clinic Recruiting
Lexington, Kentucky, United States, 40504
Contact: Cale A. Jacobs, PhD    859-258-8238    cjaco@lexclin.com   
Sponsors and Collaborators
New Lexington Clinic
Biomet Orthopedics, LLC
Investigators
Principal Investigator: Christian P Christensen, MD Lexington Clinic
  More Information

No publications provided

Responsible Party: New Lexington Clinic
ClinicalTrials.gov Identifier: NCT01807494     History of Changes
Other Study ID Numbers: LCO.2012.05
Study First Received: March 4, 2013
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 30, 2014