Feasibility study of a trial of arthroscopic surgery for hip impingement compared with non-operative care

ISRCTN ISRCTN09754699
DOI https://doi.org/10.1186/ISRCTN09754699
Secondary identifying numbers HTA 10/41/02
Submission date
20/02/2012
Registration date
20/02/2012
Last edited
16/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Damian Griffin
Scientific

University of Warwick
Division of Health Sciences
Clinical Science Research Laboratories
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Study information

Study designFeasibility study with a mulitcentre pilot randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please contact Rachel Hobson (R.W.Hobson@warwick.ac.uk) to request a patient information sheet
Scientific titleUK FASHIoN: Feasibility study of a trial of Arthroscopic Surgery for Hip Impingement compared with Non-operative care
Study acronymUK FASHIoN
Study objectivesWe 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(s)NRES West Midlands, 15/02/2012, ref: 11/WM/0389
Health condition(s) or problem(s) studiedFemoroacetabular impingement (FAI)
InterventionHip 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 typeProcedure/Surgery
Primary outcome measureNon-Arthritic Hip Score (NAHS)
Secondary outcome measures1. IHOT-33
2. SF-36
3. EQ-5D
Overall study start date01/03/2012
Completion date01/09/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit16 Years
SexBoth
Target number of participants60
Key inclusion criteriaCurrent 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
Key exclusion criteria1. 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
Date of first enrolment01/03/2012
Date of final enrolment01/09/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Warwick
Coventry
CV2 2DX
United Kingdom

Sponsor information

University Hospitals Coventry & Warwickshire (UK)
Hospital/treatment centre

c/o Mrs Ceri Jones (Research & Development Manager)
University Hospital, Coventry
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom

Website http://www.uhcw.nhs.uk/
ROR logo "ROR" https://ror.org/025n38288

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2016 Yes No
Results article results 01/10/2016 Yes No

Editorial Notes

16/09/2016: Publication reference added.
05/05/2016: Publication reference added.
13/03/2012: study design updated from multi-centre single-blind randomised controlled trial to feasibility study with a mulitcentre pilot randomised controlled trial.