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

University of Oxford2 sites in 1 country120 target enrollmentJuly 2013

ConditionsFemoroacetabular Impingement

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Femoroacetabular Impingement
Sponsor: University of Oxford
Enrollment: 120
Locations: 2
Primary Endpoint: Hip Outcome Score
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

July 2017

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Oxford

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hip Outcome Score

Time Frame: 8 months post randomisation (approximately 6 months post intervention)

Hip Outcome Score is a patient reported outcome measure

Secondary Outcomes

Hip Radiographs(Regular intervals up to 38 months post randomisation (approximately 3 years post intervention))
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))
Clinical Examination(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))