Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Femoroacetabular Impingement

Intervention / Treatment
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* Procedure: Arthroscopic hip surgery
* Other: Physical therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip Outcome Score (HOS) | 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 | 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 | 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 | 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 |  | 2 weeks, and at months 3, 6, 12, 18, and 24. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Intention to treat