Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement

February 6, 2013 updated by: University of Western Ontario, Canada

A Randomized Controlled Trial Comparing Arthroscopic Surgery to Conservative Management of Femoroacetabular Impingement

The objective of this study is to determine if patients with femoroacetabular impingement (FAI) who undergo arthroscopic hip surgery experience similar outcomes at 2 years post-operative with respect to physical function, pain, and health related quality of life, compared to similar patients who receive conservative management, including medication and physiotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Arthroscopic surgery is now commonly used to treat patients with femoroacetabular impingement (FAI) however there is a lack of scientific evidence to support its efficacy. Two distinct types of FAI have been defined: cam impingement and pincer impingement. Cam impingement is described as an abnormally prominent anterolateral femoral head-neck junction that rubs against the acetabular rim during flexion resulting in impingement of the acetabular labrum. Pincer impingement is described as an anatomical overcoverage of the femoral head by the acetabulum that impinges the labrum leading to proliferation, or an increase in the prominence of the acetabular rim, further exacerbating the impingement. Previous studies investigating the efficacy of arthroscopic surgery of the knee and shoulder have shown no benefit compared to sham surgery and non-surgical management, therefore strong scientific evidence is needed to support its use in the treatment of hip pathology.

Study Type

Interventional

Enrollment (Anticipated)

140

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 Contact

  • Name: Stacey Wanlin
  • Phone Number: 80946 519-661-2111
  • Email: swanlin@uwo.ca

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6G 2K3
        • Recruiting
        • London Health Sciences Center, University Hospital

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with femoroacetabular impingement of the hip
  • 18 years of age or older
  • grade 1, 2 or 3 radiographic severity of osteoarthritis as defined by the Tonnis classification scale.

Exclusion Criteria:

  • identified isolated labral tear
  • inflammatory or post-infectious arthritis
  • previous arthroscopic treatment for hip osteoarthritis
  • previous major hip trauma
  • Tönnis grade 4 osteoarthritis in two compartments in persons over 60 years of age.
  • patients with a major neurologic deficit, serious medical illness (life expectancy less than 2 years or high intraoperative risk) or those who are unable to provide informed consent or who are deemed unlikely to comply with follow-up.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arthroscopic surgery
Arthroscopic surgery of the hip plus optimized medical management
Procedure: Arthroscopic hip surgery
Hip arthroscopy
ACTIVE_COMPARATOR: Conservative management
Physical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication.
Other: Physical therapy
Physical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip Outcome Score (HOS)
Time Frame: 24 months
The HOS is a disease-specific questionnaire with high reliability and internal consistency. The index has 2 subscales: Activities of Daily Living (ADL) and Sports. Items are scored from 0-4, or N/A which removes item from scoring. The highest potential score is the total number of items with a response multiplied by 4. The item score divided by the highest potential score, multiplied by 100, generates a percentage. A higher score represents a higher level of physical function. The minimal clinically important difference is 9 points for the ADL subscale and 6 points for the Sports subscale.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-Arthritic Hip Score
Time Frame: 2 weeks, and at months 3, 6, 12, 18, and 24.
The Non-Arthritic Hip Score (NAHS) is a validated disease-specific questionnaire, consisting of 20 questions, divided into four domains: Pain, Symptoms, Physical Function, and Participation. Items are scored from 0-4, and added together for an overall total score. A higher score represents a higher level of physical function and less pain and symptoms. The NAHS has demonstrated good validity and has high internal consistency.
2 weeks, and at months 3, 6, 12, 18, and 24.
Modified Harris Hip Score
Time Frame: 2 weeks, and at months 3, 6, 12, 18, and 24.
The Modified Harris Hip Score is a modification of the Harris Hip Score which was originally developed for use in total hip arthroplasty patients. The modified version includes only the pain and function domains (range of motion and deformity domains from original version are removed) for a total score out of 100 points, with a higher score indicating greater function and less pain.
2 weeks, and at months 3, 6, 12, 18, and 24.
SF-12
Time Frame: 2 weeks, and at months 3, 6, 12, 18, and 24.
The SF-12 is a 12-item generic general health instrument that evaluates eight domains including restrictions or limitations on physical and social activities, normal activities and responsibilities of daily living, pain, mental health and well-being, and perceptions of health. The SF-12 has been extensively used, and has been shown to be valid, reliable, and responsive in a wide variety of populations and contexts including patients with orthopedic conditions. It is generally accepted that the minimally important difference for the SF-12 ranges from 3-5 points.
2 weeks, and at months 3, 6, 12, 18, and 24.
Range of Motion
Time Frame: 2 weeks, and at months 3, 6, 12, 18, and 24.
2 weeks, and at months 3, 6, 12, 18, and 24.

Collaborators and Investigators

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

Sponsor

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Douglas Naudie, MD, FRCSC, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2014

Study Completion (ANTICIPATED)

May 1, 2014

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

June 13, 2012

First Posted (ESTIMATE)

June 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKSMC-2011-01

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.

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