Trial for Femoroacetabular Impingement Treatment

Femoroacetabular Impingement Clinical Trial

— FAIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01893034
• Other study ID #: FAIT
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2013
• Last updated: December 2, 2013
• Start date: July 2013
• Est. completion date: July 2017

Study information

• Verified date: December 2013
• Source: University of Oxford
• Contact: Antony Palmer, MA BMBCh
• Phone: +441865 227374
• Email: antony.palmer[@]ndorms.ox.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

Procedure:
• Arthroscopic treatment of femoroacetabular impingement

Other:
• Physiotherapy and activity modification

Locations

Country	Name	City	State
United Kingdom	Nuffield Orthopaedic Centre, Oxford University Hospitals Trust	Oxford
United Kingdom	Royal Berkshire Hospital	Reading

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip Outcome Score	Hip Outcome Score is a patient reported outcome measure	8 months post randomisation (approximately 6 months post intervention)	No
Secondary	Patient Reported Outcome Measures		Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)	No
Secondary	Morphological and Physiological MRI	Morphological Parameters; Measures of Osteoarthritis	Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)	No
Secondary	Hip Radiographs	Morphological Parameters; Measures of Osteoarthritis	Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)	No
Secondary	Serum and Urinary Biomarkers of Osteoarthritis		Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)	No
Secondary	Clinical Examination	Range of Movement; Impingement Tests	Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)	No