Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Western Ontario, Canada
Sponsor:
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01621360
First received: December 19, 2011
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Femoroacetabular Impingement
Procedure: Arthroscopic hip surgery
Other: Physical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Arthroscopic Surgery to Conservative Management of Femoroacetabular Impingement

Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • Hip Outcome Score (HOS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Non-Arthritic Hip Score [ Time Frame: 2 weeks, and at months 3, 6, 12, 18, and 24. ] [ Designated as safety issue: No ]
    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.

  • Modified Harris Hip Score [ Time Frame: 2 weeks, and at months 3, 6, 12, 18, and 24. ] [ Designated as safety issue: No ]
    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.

  • SF-12 [ Time Frame: 2 weeks, and at months 3, 6, 12, 18, and 24. ] [ Designated as safety issue: No ]
    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.

  • Range of Motion [ Time Frame: 2 weeks, and at months 3, 6, 12, 18, and 24. ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01621360

Contacts
Contact: Stacey Wanlin 519-661-2111 ext 80946 swanlin@uwo.ca

Locations
Canada, Ontario
London Health Sciences Center, University Hospital Recruiting
London, Ontario, Canada, N6G 2K3
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Principal Investigator: Douglas Naudie, MD, FRCSC University of Western Ontario, Canada
  More Information

Publications:

Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01621360     History of Changes
Other Study ID Numbers: FKSMC-2011-01
Study First Received: December 19, 2011
Last Updated: February 6, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Western Ontario, Canada:
Randomized controlled trial
Intention to treat

Additional relevant MeSH terms:
Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014