Condition category
Surgery
Date applied
20/02/2012
Date assigned
20/02/2012
Last edited
16/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Damian Griffin

ORCID ID

Contact details

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

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 measures

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

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

http://www.uhcw.nhs.uk/

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

Federal/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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27117505
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27629405

Publication citations

Additional files

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.