Trial for Femoroacetabular Impingement Treatment

Not Applicable

• Conditions: Femoroacetabular Impingement
• Interventions: Other: Physiotherapy and activity modification; Procedure: Arthroscopic treatment of femoroacetabular impingement

• Registration Number: NCT01893034
• Lead Sponsor: University of Oxford

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-14
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-03
• Primary Completion: 2015-04
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Physiotherapy and activity modification	Physiotherapy and activity modification
Surgical treatment	Arthroscopic treatment of femoroacetabular impingement	Arthroscopic treatment of femoroacetabular impingement

Primary Outcome Measures

Name	Time	Method
Hip Outcome Score	8 months post randomisation (approximately 6 months post intervention)	Hip Outcome Score is a patient reported outcome measure

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Royal Berkshire Hospital; 🇬🇧 Reading, United Kingdom

Nuffield Orthopaedic Centre, Oxford University Hospitals Trust; 🇬🇧 Oxford, United Kingdom