Outcomes Following Anterior Approach to Total Hip Arthroplasty (AAP)

This study has been terminated.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01353885
First received: May 11, 2011
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

Osteoarthritis disables approximately 10% of people who are 60 years or older and compromises the quality of life of more than 20 million Americans every year. Osteoarthritis is caused by the breakdown of cartilage that lines the bones at your joints from daily wear and tear and results in pain and restricted function. Total hip arthroplasty (THA) or total hip replacement, is currently one of the most successful and cost-effective treatments used to eliminate pain and restore function in those suffering from osteoarthritis. There are multiple ways to perform a THA. The main difference between each type is the point of incision in relation to a muscle on the outer surface of your hip bone: gluteus medius. The incision performed can be anterior (in front of the muscle), anterolateral (in front and to the side of the muscle), or posterior (from the back). Each of these approaches has its own advantages and disadvantages, but there is no evidence available that makes one better than the other. The purpose of this study is to determine which of the three approaches to THA is the most effective. The main outcome that will determine the most effective approach is the functional ability of the patients included in this study at 52 weeks. The investigators will also compare whether the patient's: length of hospital stay, use of assistive devices, need for revision surgery, ability to return to work, ability to relieve pain, complication rate, and quality of life. The investigators hypothesize that the anterior approach will be the most effective approach in reducing the rate of post-operative complications after THA.


Condition
Osteoarthritis, Hip

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes Following Anterior Approach to Total Hip Arthroplasty: A Multi-Centre Observational Cohort Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Patient Functional Ability [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    Measured by the Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaire.


Secondary Outcome Measures:
  • Technical Parameters [ Time Frame: 1 day - measured during and post-operatively ] [ Designated as safety issue: No ]
    Length of Incision (cm), Blood Loss (mL), Fluoroscopy Time (s), Operative Time (Min)

  • Length of Hospital Stay [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Duration of time patient is in hospital post-operatively.

  • Use of Assistive Device [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Presence of an assistive device(s) provided to patients at discharge and the length of time it takes the patient to discard the assistive device(s).

  • Revision Surgery [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Occurrence and type of revision surgery required (if any)

  • Ability to participate in sports activities [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Subjectively reported.

  • Return to Work [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    Measured by the Work Limitations Questionnaire (WLQ)- short form format

  • Complication Rate [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    We will define complications in patients as a constellation of clinical symptoms and laboratory examinations. These will include (but are not limited to) both intraoperative and postoperative complications; More specifically, musculoskeletal, cardiovascular, psychological, neurological, genitourinary, and wound-related complications.

  • Pain [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    Measured by the EuroQol-5d (EQ-5D) and Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaires.

  • Quality of Life [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    Measured by the EuroQol-5d (EQ-5D) and Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaires.


Enrollment: 50
Study Start Date: February 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Anterior Approach THA
500 Patients will be included who have received a total hip arthroplasty using the Anterior Approach. The anterior approach to total hip arthroplasty refers to an internervous approach to the hip, where the incision is made from the middle of the iliac crest, then curved distally and laterally to the anterior superior iliac spine (Kelmanovich et al., 2003). To optimize feasibility and applicability of our results, we will not standardize the use of cemented components, the implant manufacturer, or the femoral head size. Surgeons will use the manufacturer specific guides for insertion of the total hip arthroplasty.
Posterior Approach THA
100 patients will be enrolled who have received a total hip arthroplasty using the posterior approach. The posterior approach is performed by making a curved incision posteriorly on the greater trochanter (Jolles & Bogoch, 2004). The fascia lata is then incised and the fibers of the gluteus maximus split using dissection (Jolles & Bogoch, 2004). To ensure the feasibility and applicability of our findings, we will not standardize the use of cemented components, the implant manufacturer, or the femoral head size used in the posterior approach.
Anterolateral Approach THA
100 patients will be enrolled who have had a total hip arthroplasty using the anterolateral approach. An anterolateral approach to THA utilizes an intermuscular approach by incising the patient posteriorly and distally to the anterior superior iliac spine, extending distally to the greater trochanter along the shaft of the femur (Kelmanovich et al., 2003). To optimize the feasibility and applicability of our results, the implant manufacturer, femoral head size or the use of cemented components will not be standardized in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men or women who are 18 years of age or older with a primary diagnosis of hip arthritis (radiographically and clinically). Patients must be undergoing an unilateral THA and have had no previous major hip surgery (hip arthroscopy is permitted) or hardware implanted in their hip.

Criteria

Inclusion Criteria:

  1. Men or women who are 18 years of age or older.
  2. Primary diagnosis of hip arthritis (radiographically and clinically).
  3. Patients undergoing an unilateral THA.
  4. Provision of informed consent by patient.

Exclusion Criteria:

  1. Patients being managed with alternative approaches (other than anterior, anterolateral or posterior THA) will be excluded.
  2. Patients undergoing a revision THA.
  3. Patients undergoing a bilateral THA.
  4. Patients with infection around the hip (soft tissue or bone).
  5. Patients who have had previous major hip surgery (hip arthroscopy is permitted) or hardware implanted in their hip.
  6. Patients who are currently enrolled in another surgical intervention trial.
  7. Patient has cognitive or language barriers that would limit completion of quality of life, pain, and function questionnaires in English.
  8. Anticipated problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
  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: NCT01353885

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8L 8E7
Sponsors and Collaborators
McMaster University
DePuy Orthopaedics
Investigators
Principal Investigator: Mohit Bhandari, MD, PhD, FRCSC McMaster University
Principal Investigator: Joel Matta, MD St. Joseph's Health Centre
  More Information

Publications:
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01353885     History of Changes
Other Study ID Numbers: Depuy-05072
Study First Received: May 11, 2011
Last Updated: August 12, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by McMaster University:
Primary Osteoarthritis, Hip
Total Hip Arthroplasty
Anterior Approach
Posterior Approach
Anterolateral Approach
Cohort Study
Outcomes, Complication Rate
Outcomes, Quality of Life

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

ClinicalTrials.gov processed this record on October 19, 2014