Clinical trial NCT01893034: Trial for Femoroacetabular Impingement Treatment
Official title: A Randomised Controlled Trial of Surgical Versus Non-surgical Treatment of Femoroacetabular Impingement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoroacetabular Impingement
Keywords: Femoroacetabular Impingement
Arthroscopy
Physiotherapy
Randomised Controlled Trial
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2013-07-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hip Outcome Score
timeFrame: 8 months post randomisation (approximately 6 months post intervention)
Secondary outcomes:
measure: Patient Reported Outcome Measures
timeFrame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
measure: Morphological and Physiological MRI
timeFrame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
measure: Hip Radiographs
timeFrame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
measure: Serum and Urinary Biomarkers of Osteoarthritis
timeFrame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
measure: Clinical Examination
timeFrame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
Study officials:
affiliation: University of Oxford
name: Sion Glyn-Jones, MA MBBS FRCS DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer AJR, Ayyar Gupta V, Fernquest S, Rombach I, Dutton SJ, Mansour R, Wood S, Khanduja V, Pollard TCB, McCaskie AW, Barker KL, Andrade TJMD, Carr AJ, Beard DJ, Glyn-Jones S; FAIT Study Group. Arthroscopic hip surgery compared with physiotherapy and activity modification for the treatment of symptomatic femoroacetabular impingement: multicentre randomised controlled trial. BMJ. 2019 Feb 7;364:l185. doi: 10.1136/bmj.l185.
citation: Palmer AJ, Ayyar-Gupta V, Dutton SJ, Rombach I, Cooper CD, Pollard TC, Hollinghurst D, Taylor A, Barker KL, McNally EG, Beard DJ, Andrade AJ, Carr AJ, Glyn-Jones S. Protocol for the Femoroacetabular Impingement Trial (FAIT): a multi-centre randomised controlled trial comparing surgical and non-surgical management of femoroacetabular impingement. Bone Joint Res. 2014 Nov;3(11):321-7. doi: 10.1302/2046-3758.311.2000336.