Femoroacetabular Impingement
Conditions
Keywords
Randomized controlled trial, Intention to treat
Brief summary
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.
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.
Interventions
PROCEDUREArthroscopic hip surgery
Hip arthroscopy
OTHERPhysical therapy
Physical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication.
Sponsors
University of Western Ontario, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hip Outcome Score (HOS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-Arthritic Hip Score | 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. |
| Modified Harris Hip Score | 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. |
| SF-12 | 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. |
| Range of Motion | 2 weeks, and at months 3, 6, 12, 18, and 24. | — |
Countries
Canada
Contacts
Primary ContactStacey Wanlin
Outcome results
None listed