Outcomes Following Anterior Approach to Total Hip Arthroplasty

Osteoarthritis, Hip Clinical Trial

— AAP  

Official title:

Outcomes Following Anterior Approach to Total Hip Arthroplasty: A Multi-Centre Observational Cohort Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01353885
• Other study ID #: Depuy-05072
• Status: Terminated
• Phase: N/A
• First received: May 11, 2011
• Last updated: August 12, 2014
• Start date: February 2013
• Est. completion date: October 2013

Study information

• Verified date: August 2014
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	DePuy Orthopaedics

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Jolles BM, Bogoch ER. Surgical approach for total hip arthroplasty: direct lateral or posterior? J Rheumatol. 2004 Sep;31(9):1790-6. — View Citation

Kelmanovich D, Parks ML, Sinha R, Macaulay W. Surgical approaches to total hip arthroplasty. J South Orthop Assoc. 2003 Summer;12(2):90-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Functional Ability	Measured by the Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaire.	52 Weeks	No
Secondary	Technical Parameters	Length of Incision (cm), Blood Loss (mL), Fluoroscopy Time (s), Operative Time (Min)	1 day - measured during and post-operatively	No
Secondary	Length of Hospital Stay	Duration of time patient is in hospital post-operatively.	4 weeks	No
Secondary	Use of Assistive Device	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).	52 weeks	No
Secondary	Revision Surgery	Occurrence and type of revision surgery required (if any)	52 weeks	No
Secondary	Ability to participate in sports activities	Subjectively reported.	52 weeks	No
Secondary	Return to Work	Measured by the Work Limitations Questionnaire (WLQ)- short form format	52 Weeks	No
Secondary	Complication Rate	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.	52 Weeks	No
Secondary	Pain	Measured by the EuroQol-5d (EQ-5D) and Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaires.	52 Weeks	No
Secondary	Quality of Life	Measured by the EuroQol-5d (EQ-5D) and Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaires.	52 Weeks	No