Trial for Femoroacetabular Impingement Treatment

Study Overview
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Brief Summary
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Femoroacetabular Impingement (FAI) describes a condition of the hip where additional bone results in the abutment of the femoral neck against the rim of the acetabulum. This gives rise to localised cartilage damage and pain, but also increases the risk of developing osteoarthritis. The purpose of this study is to compare the effectiveness of arthroscopic surgery versus physiotherapy and activity modification for the treatment of this condition.

Official Title
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A Randomised Controlled Trial of Surgical Versus Non-surgical Treatment of Femoroacetabular Impingement

Conditions
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Femoroacetabular Impingement

Intervention / Treatment
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* Procedure: Arthroscopic treatment of femoroacetabular impingement
* Other: Physiotherapy and activity modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic patients Age 18-60 years Clinical and radiological evidence of FAI Competent to consent Exclusion Criteria: Prior hip surgery Established osteoarthritis (Kellgren-Lawrence >/= 2) Hip dysplasia (Centre-Edge angle < 20 degrees on radiograph) Completion of physiotherapy programme targeting FAI within past year Co-morbidities that mean surgical intervention is not possible/safe Contraindication to MRI Pregnancy

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: Conservative treatment<br>Physiotherapy and activity modification | Other: Physiotherapy and activity modification<br> <br> |
| Active Comparator: Surgical treatment<br>Arthroscopic treatment of femoroacetabular impingement | Procedure: Arthroscopic treatment of femoroacetabular impingement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip Outcome Score | Hip Outcome Score is a patient reported outcome measure | 8 months post randomisation (approximately 6 months post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcome Measures |  | Regular intervals up to 38 months post randomisation (approximately 3 years post intervention) | 
| Morphological and Physiological MRI | Morphological Parameters Measures of Osteoarthritis | Regular intervals up to 38 months post randomisation (approximately 3 years post intervention) | 
| Hip Radiographs | Morphological Parameters Measures of Osteoarthritis | Regular intervals up to 38 months post randomisation (approximately 3 years post intervention) | 
| Serum and Urinary Biomarkers of Osteoarthritis |  | Regular intervals up to 38 months post randomisation (approximately 3 years post intervention) | 
| Clinical Examination | Range of Movement Impingement Tests | Regular intervals up to 38 months post randomisation (approximately 3 years post intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoroacetabular Impingement, Arthroscopy, Physiotherapy, Randomised Controlled Trial