Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 10/41/02
Study information
Scientific title
UK FASHIoN: Feasibility study of a trial of Arthroscopic Surgery for Hip Impingement compared with Non-operative care
Acronym
UK FASHIoN
Study hypothesis
We plan to establish whether it is feasible to undertake an RCT of hip arthroscopy versus best conservative care for femoroacetabular impingement (FAI).
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/104102
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0004/55408/PRO-10-41-02.pdf
Ethics approval
NRES West Midlands, 15/02/2012, ref: 11/WM/0389
Study design
Feasibility study with a mulitcentre pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Rachel Hobson (R.W.Hobson@warwick.ac.uk) to request a patient information sheet
Condition
Femoroacetabular impingement (FAI)
Intervention
Hip Arthroscopic Surgery - performed by an experienced trained surgeon.
Non-operative care - this will comprise a package of best conservative care; treatment options, including interventions that target patients pain (anti-inflammatory medication, hip joint corticosteroid injection, postural adaptations, exercise, acupuncture, manual therapy techniques) and functional difficulties (lifestyle advice, gait modification, exercise and physical activity). The focus of this intervention will be an individualised, supervised and progressed exercise rehabilitation programme.
Secondary sponsor:
University of Warwick
c/o Dr Peter Hedges (Director of Research Support Services)
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Non-Arthritic Hip Score (NAHS)
Secondary outcome measures
1. IHOT-33
2. SF-36
3. EQ-5D
Overall trial start date
01/03/2012
Overall trial end date
01/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 04/02/2013:
1. ≥ 16 years of age
2. They have symptoms of hip pain - they may also have symptoms of clicking, catching or giving way
3. They show radiographic evidence of pincer- or cam-type FAI on plain radiographs and cross-sectional imaging
4. The treating surgeon believes that they would benefit from arthroscopic FAI surgery
5. Able to give written informed consent
6. Able to participate fully in the interventions
Previous inclusion criteria until 04/02/2013:
1. Aged 18-50
2. They have symptoms of hip pain - they may also have symptoms of clicking, catching or giving way
3. They show radiographic evidence of pincer- or cam-type FAI on plain radiographs and cross-sectional imaging
4. The treating surgeon believes that they would benefit from arthroscopic FAI surgery
5. Able to give written informed consent
6. Able to participate fully in the interventions
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. They have previous significant hip pathology such as Perthes disease, slipped upper femoral epiphysis or avascular necrosis
2. They have had a previous hip injury such as acetabular fracture, hip dislocation or femoral neck fracture
3. They already have osteoarthritis, defined as Tonnis grade >150, or more than 2mm loss of superior joint space width on AP pelvic radiograph
4. There is evidence that the patient would be unable to participate fully in the interventions, adhere to trial procedures or to complete questionnaires, such as cognitive impairment or intravenous drug abuse
Recruitment start date
01/03/2012
Recruitment end date
01/09/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Warwick
Coventry
CV2 2DX
United Kingdom
Sponsor information
Organisation
University Hospitals Coventry & Warwickshire (UK)
Sponsor details
c/o Mrs Ceri Jones (Research & Development Manager)
University Hospital
Coventry
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27117505
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27629405