Arthroscopic surgery for hip impingement versus best conventional care
| ISRCTN | ISRCTN64081839 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64081839 |
| Secondary identifying numbers | HTA 13/103/02 |
- Submission date
- 20/02/2014
- Registration date
- 28/02/2014
- Last edited
- 02/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
The hip joint has two bones that fit together like a ball in a socket. In some people these bones press against each other and can cause pain. The medical term for this is femororacetabular impingement (FAI for short). Parts of the hip called the 'labrum' and 'cartilage' cushion the hip joint and allow the smooth friction-free movement. FAI can injure both the labrum and cartilage and also cause pain. There is now good evidence to suggest a link between FAI and the development of premature osteoarthritis (wear and tear) of the hip, but we do not know who best to treat FAI. There has been a rapid increase in the use of keyhole surgery to treat this condition. This operation is called 'hip arthroscopy'. During hip arthroscopy the patient is put to sleep and the surgeon passes a small telescope and tools into the hip joint through small cuts in the skin. The tools are used to reshape bone around the hip to prevent further impingement. Many patients have already undergone surgery and had improvements in pain and hip function in the short to medium term. However, this research was not compared to conventional care and it is possible that they may have similar levels of improvement without an operation. An alternative treatment option for patients is a course of best conventional care (a structured programme of exercise-based care supervised by a physiotherapist - this has been called personalised hip therapy) aimed at improving the muscle strength and control around the hip joint. There are fewer risks associated with this type of treatment and it is less expensive. We therefore propose a study to find out which of these two treatments is most effective for treating patients with FAI up to 12 months after treatment.
Who can participate?
The study aims to recruit 302 patients with hip pain, aged 16 and above.
What does the study involve?
Patients are randomly allocated to either undergo arthroscopic surgery or receive usual care. Participants will receive their allocated treatment and will then be required to complete some questionnaires at 6, 12, 24 and 36 months. At 12 months we will conduct our first analysis to measure the effectiveness of the two treatments.
What are the possible benefits and risks of participating?
There are no specific benefits to the participating patients, but future patients should benefit as the study will provide information on how best to treat this condition. The risks are small and include infection, bleeding, numbness, osteonecrosis (death of bone tissue) and neck fractures. For those patients allocated to usual care there is a small risk with pain medications and joint injections. However, the main risk is muscle soreness and temporary increases in pain from exercises.
Where is the study run from?
The study is run from 25 NHS Trusts throughout the UK.
When is the study starting and how long is it expected to run for?
It is expected that recruitment will start in July 2014 and participants will be enrolled onto the study over a 2-year period.
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Damian Griffin
Damian.griffin@warwick.ac.uk
Contact information
Scientific
Warwick Clinical Trials Unit, Division of Health Sciences
Warwick Medical School
University of Warwick
Clinical Sciences Research Laboratories
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
| Phone | +44 (0)24 7696 8618 |
|---|---|
| damian.griffin@warwick.ac.uk |
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Rachel Hobson (r.w.hobson@warwick.ac.uk) to request patient information sheet. |
| Scientific title | Full randomised controlled trial of Arthroscopic Surgery for Hip Impingement versus best CoNventional Care |
| Study acronym | UK FASHIoN |
| Study hypothesis | What is the clinical and cost-effectiveness of hip arthroscopy for femororacetabular impingement (FAI) in comparison to best conventional care? More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/1310302 Protocol can be found at: http://www.nets.nihr.ac.uk/projects/hta/1310302 |
| Ethics approval(s) | NRES Committee West Midlands - Edgbaston, 01/05/2014, REC ref: 14/WM/0124 |
| Condition | Femoroacetabular impingement (FAI) |
| Intervention | Participants will be recruited from 25 sites across the NHS in England, Scotland and Wales. Participation will be over a 3-year period. Participants will be allocated to either: 1. Hip Arthroscopic Surgery - performed by an experienced trained surgeon 2. Best Conservative Care - a package of physiotherapy-led therapy entitled 'Personalised Hip Therapy' given over a 12-week period with an option of two further booster sessions up to 6 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Clinical effectiveness of hip arthroscopy, assessed by patient-reported hip-specific quality of life after one year |
| Secondary outcome measures | 1. General health status and health-related quality of life after 12 months 2. Pattern of clinical change over 12 months 3. Patient satisfaction with treatment and outcome after one year 4. Number and severity of adverse events after treatment 5. Need for further procedures up to three years 6. Cost-effectiveness within the trial and for a patient's lifetime 7. Develop and report processes to optimise recruitment in an RCT or surgery versus non-operative care 8. Fidelity of delivery of interventions |
| Overall study start date | 01/04/2014 |
| Overall study end date | 30/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 344 |
| Total final enrolment | 348 |
| Participant inclusion criteria | Inclusion criteria as of 15/03/2016: 1. Age ≥16 (no upper age limit) 2. Symptoms of hip pain - patients may also have symptoms of clicking, catching or giving way 3. Radiographic evidence of pincer- and/or cam-type FAI morphology on plain radiographs and cross-sectional imaging, defined as: 3.1. Cam morphology - an alpha angle >55º; 3.2. Pincer morphology - a lateral centre edge angle of >40 degrees or a crossover sign on the anteroposterior radiograph of the pelvis 4. The treating surgeon believes the patient would benefit from arthroscopic FAI surgery 5. The patient is able to give written informed consent and to participate fully in the interventions and follow-up procedures Original inclusion criteria: 1. Age ≥16 (no upper age limit) 2. Symptoms of hip pain - patients may also have symptoms of clicking, catching or giving way 3. Radiographic evidence of pincer- or cam-type FAI on plain radiographs confirmed with cross-sectional imaging, defined as alpha angle >55° or lateral centre edge angle >40° 4. The treating surgeon believes the patient would benefit from arthroscopic FAI surgery 5. The patient is able to give written informed consent and to participate fully in the interventions and follow-up procedures |
| Participant exclusion criteria | 1. Evidence of pre-existing osteoarthritis, defined as Tonnis grade >1, or more than 2 mm loss of superior joint space width on AP pelvic radiograph 2. Previous significant hip pathology such as Perthes' disease, slipped upper femoral epiphysis, or avascular necrosis 3. Previous hip injury such as acetabular fracture, hip dislocation or femoral neck fracture 4. Previous shape changing surgery (open or arthroscopic) in the hip being considered for treatment |
| Recruitment start date | 01/07/2014 |
| Recruitment end date | 30/07/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CV2 2DX
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Mrs Ceri Jones (Research and Development Manager)
University Hospital, Coventry
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom
| Phone | +44 (0)24 7696 5623 |
|---|---|
| ceri.jones@uhcw.nhs.uk | |
| Website | http://www.uhcw.nhs.uk/ |
"ROR" |
https://ror.org/025n38288 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 31/08/2016 | Yes | No | |
| Results article | results | 02/06/2018 | Yes | No | |
| Results article | results in Health Technology Assessment | 01/02/2022 | 02/03/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
02/03/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
13/06/2018: Publication reference added.
02/09/2016: Publication reference added.
18/03/2016: Information regarding the availability of the participant level data has been added.
15/03/2016: The inclusion criteria have been updated and the target number of participants has been updated from 302 to 344.
