FLexor repAir and REhabilitation (FLARE) Trial
| ISRCTN | ISRCTN10918157 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10918157 |
| IRAS number | 316277 |
| Secondary identifying numbers | IRAS 316277, CPMS 54953 |
- Submission date
- 07/10/2022
- Registration date
- 12/01/2023
- Last edited
- 01/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
A deep cut through the fingers is a common injury that damages the flexor tendons. They are smooth cords that help the fingers to bend. There are two flexor tendons in each finger, which join the muscles in the forearm to the bones in the fingers. One tendon bends the middle knuckle, the other bends the fingertip. Flexor tendon injuries to the finger are more common in young adults. The usual treatment is an operation to stitch the severed tendon ends together, followed by 12 weeks of rehabilitation. There is low-quality evidence as to whether repairing both tendons is better than one tendon alone. In order to generate good quality evidence that can guide practice, the repair of one tendon alone needs to be formally tested in a clinical trial.
The aim of this study is to conduct a two-arm randomised controlled trial comparing the repair of one tendon versus repairs of both tendons in complete zone 2 injuries.
Who can participate?
Adult patients (who are 16 years old or older), who attend a participating hospital with an open injury in zone 2 of a single finger and where the complete division of both flexor tendons is suspected
What does the study involve?
Participants will be randomly allocated to receive either surgery to repair one tendon only or surgery to repair both tendons. Participants will be assessed at the start of the study, then at 1 week, 6 weeks, 3 months and 6 months after surgery. Participants will be asked to complete questionnaires, and a clinical assessment of the range of motion and grip strength is undertaken. Rehabilitation will be according to routine practice at the treating hospital. A subset of participants will take part in an interview about their experiences and receiving treatment for this injury, their recovery and taking part in the research. The cost of both treatments is calculated relative to their benefits to find out which is better value for money for the NHS.
What are the possible benefits and risks of participating?
Participants may not benefit from taking part, however, if enough people take part in this study, the information we get should help ensure that people with these injuries have informed treatment choices in the future. This study only includes interventions that are already used in the NHS. As with many medical procedures, there are some potential risks, mainly in relation to surgery and anaesthesia. Participants in both groups will undergo surgery and risk is not increased through trial participation. Flexor tendon repair patients usually have a splint to wear during rehabilitation, whether or not they participate in the study. Splints have the potential to be uncomfortable and may cause skin irritation and stiffness.
Where is the study run from?
York Trials Unit, University of York (UK)
When is the study starting and how long is it expected to run for?
April 2022 to July 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (HTA) Ref: 133784 (UK)
Who is the main contact?
Mr Matthew Gardiner, matthew.gardiner@nhs.net (UK)
Contact information
Scientific
The FLARE Trial
York Trials Unit
Department of Health
University of York
Heslington
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0001-6902-0235 |
|---|---|
| Phone | +44 (0)1904 321522 |
| liz.cook@york.ac.uk |
Principal Investigator
Department of Plastic Surgery
Wexham Park Hospital
Wexham Street
Slough
SL2 4HL
United Kingdom
| ORCID ID |
0000-0002-8058-4186 |
|---|---|
| Phone | +44 (0)300 614 5000 |
| matthew.gardiner@nhs.net |
Principal Investigator
Trauma & Orthopaedics
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
| Phone | +44 (0)1642 850850 |
|---|---|
| emma.reay1@nhs.net |
Study information
| Study design | Multicentre two-arm parallel-group non-inferiority randomized controlled trial with an internal pilot economic evaluation and nested qualitative study |
|---|---|
| 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 use the contact details to request a participant information sheet |
| Scientific title | A randomised trial to determine the clinical and cost-effectiveness of repairing flexor digitorum profundus (FDP) alone versus repair of both FDP and flexor digitorum superficialis (FDS) for treatment of complete zone 2 flexor tendon injuries: the FLexor repAir and 'REhabilitation (FLARE) Trial |
| Study acronym | FLARE |
| Study objectives | Flexor digitorum profundus (FDP) repair alone is not inferior to FDP and flexor digitorum superficialis (FDS) repair for the treatment of recent complete zone 2 flexor tendon injuries in adults based on the patient reported outcome Patient Evaluation Measure (PEM) at 6-months post-randomisation. |
| Ethics approval(s) | Approved 07/03/2023, North West - Greater Manchester Central Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 1048191; gmcentral.rec@hra.nhs.uk), ref: 23/NW/0004 |
| Health condition(s) or problem(s) studied | Traumatic injury to the hand in zone 2 injuries causing the flexor digitorum profundus and flexor digitorum superficialis to be severed. |
| Intervention | Main FLARE trial The intervention is repair of flexor digitorum profundus (FDP) alone, compared to the usual practice of the repair of FDP and flexor digitorum superficialis. Participants will undergo treatment as per the randomisation allocation schedule under the care of one of the participating surgeons Associate PI Study Within A Trial (API SWAT) A 2x2 factorial SWAT embedded in the main trial utilising the NIHR API Scheme. All sites recruiting to FLARE who have a confirmed Associate PI (API) will be included. Aim is to evaluate the effect on recruitment rates of using two interventions: Enhanced Associate Principal Investigator Package and Digital Nudging on participant recruitment rates. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Main FLARE trial Patient assessment of treatment, hand health and overall hand assessment, measured using a Patient Evaluation Measure (PEM) at 6 months post-surgery |
| Secondary outcome measures | Main FLARE trial 1. Patient assessment of hand/wrist pain and disability in activities of daily living, measured using the Patient Related Wrist/Hand Evaluation (PRWHE) at baseline, 6 weeks, 3 months and 6 months post-surgery 2. Quality of life measured using the EQ-5D-5L questionnaire at baseline, 6 weeks, 3 months and 6 months post-surgery 3. Complications and Adverse Events collected by patient-reported questionnaires and review of hospital records up to 6 months post-surgery 4. Total range of motion, measured using a goniometer at 6 weeks and 3 months post-surgery 5. Grip strength measured using a dynamometer at 3 months post-surgery 6. Adherence to the splint regimen measured using patient self-report at 6 weeks post-surgery 7. Work outcomes measured using patient self-report at 6 weeks, 3 months and 6 months post-surgery 8.Treatment and outcome satisfaction measured using a net promoter score and PEM at 6 weeks, 3 months and 6 months post-surgery 9. Healthcare resource use measured patient self-report and medical records at surgery, up to 1 week, 6 weeks, 3 months and 6 months post-surgery 10. Adherence to the therapy regimen measured using patient self-report at 6 weeks and 3 months post-surgery |
| Overall study start date | 01/04/2022 |
| Completion date | 31/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 310 |
| Key inclusion criteria | Inclusion criteria for screening: 1. Patients aged 16 years old and over Inclusion Criteria for randomisation (confirmed in surgery): 2. Complete division of FDP and FDS in zone 2 of a single finger 3. Injury amenable to primary repair |
| Key exclusion criteria | Eligibility criteria for screening: 1. Injuries affecting more than one digit or the thumb 2. Injuries outside of Zone 2 3. Injuries affecting multiple zones 4. Clinically infected wounds 5. Closed flexor tendon injury 6. Previous tendon, bone or joint injury in the affected digit 7. Patient does not have capacity to give informed consent 8. Patient unable to complete follow-up requirements 9. Contraindications to surgery Exclusion criteria for randomisation (confirmed at surgery): 10. Injuries with loss of tendon substance or skin necessitating reconstruction 11. Division of both digital arteries resulting in revascularisation of injured digit 12. Division of both digital nerves |
| Date of first enrolment | 23/08/2023 |
| Date of final enrolment | 30/04/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Wexham
Slough
SL2 4HL
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Leeds
LS1 3EX
United Kingdom
Newtown Road
Carlisle
CA2 7HY
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
Truro
TR1 3LJ
United Kingdom
Aylesbury
HP21 8AL
United Kingdom
London
SW17 0QT
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Dryburn Hospital
North Road
Durham
DH1 5TW
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Larbert
FK5 4WR
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Cwmrhydyceirw
Swansea
SA6 6NL
United Kingdom
369 Fulham Road
London
SW10 9NH
United Kingdom
East Grinstead
RH19 3DZ
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Sponsor information
Hospital/treatment centre
STRIVE Academic Centre
The James Cook University hospital
Middlesborough
TS4 3BW
England
United Kingdom
| Phone | +44 (0)1642850850 |
|---|---|
| dtvra.projects@nhs.net | |
| Website | http://southtees.nhs.uk/ |
"ROR" |
https://ror.org/02js17r36 |
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 | 31/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A dissemination and publication policy will be developed with an agreement between partners including ownership and exploitation of intellectual property, and publication rights. The publication policy and the agreement will ensure that any intellectual property generated during the project is protected and that the publication process is organised in a fair, balanced and transparent manner. The TMG will be responsible for overseeing these arrangements. The creation and signature of the agreements will be the responsibility of the coordinating centre (University of York). It will be ensured that all partners have input into the document. Targets for dissemination will include NICE, Clinical Commissioning Groups, the Department of Health and the Speciality Advisory Committees (SAC) for the curriculum for clinicians who will undertake treatment of flexor tendon repairs. The study protocol and results will be presented orally and will be made publicly available in appropriate publications and a summary of the study will be made available in plain English for patient-focused outlets. The executive summary and copy of the trial report will be sent to NICE and other relevant bodies, including Clinical Commissioning Groups, so that the study findings can inform their deliberations and be translated into clinical practice nationally. We will also work with the relevant National Clinical Director in the Department of Health to help ensure the findings of the trial are considered when implementing policy and will work with the Speciality Advisory Committees (SAC) to incorporate the findings into the training curriculum for clinicians who will undertake treatment of flexor tendon injuries. A number of dissemination channels will be used to inform clinicians, patients and the public about the results of the study. The projected outputs are listed below. We will seek to raise the profile of the trial via social media including a dedicated Twitter account. This will be aimed at participating site staff and focus on trial progress, trial related events, and publicising research outputs. The study protocol will be published in a peer-reviewed, open access journal, after the study commences. A HTA monograph will be produced. On completion of the study, the findings of the HTA report will be presented at national and international meetings such as the International Federation of Societies for Surgery of the Hand (IFSSH) and Hand Therapy (IFSHT). The study report will be published in peer reviewed high impact general medical, surgical and hand therapy journals; such as Lancet, the BMJ, the Journal of Hand Surgery (European), Hand Therapy or Journal of Hand Therapy. The study results will be shared with relevant evidence synthesis teams (including within the Cochrane Collaboration) in order to ensure that results are incorporated in future systematic reviews. A summary of the study report, written in lay language will be produced and made available to participants, members of our user group and relevant patient-focused websites. As part of the trial an information booklet on the condition, the likely recovery process and hand exercises will be produced. We will explore making this more widely available to patients following the trial. The findings of the SWAT will be disseminated in a relevant journal read by trialists such as BMC Trials and disseminated at relevant conferences such as the International Clinical Trials Methodology Conference. Data will be made available to allow for inclusion in future meta-analyses with studies of the same intervention in other trials. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study (fully anonymised) will be available upon request after the publication of the study results from Prof. Catherine Hewitt (catherine.hewitt@york.ac.uk). Participants will be informed that information collected about them may be shared anonymously with other researchers and will be asked to consent to this. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Statistical Analysis Plan | version 1.0 | 28/04/2025 | 01/05/2025 | No | No |
| Statistical Analysis Plan | version 1.0 | 14/04/2025 | 01/05/2025 | No | No |
Additional files
Editorial Notes
01/05/2025: Statistical analysis plan and health economics analysis plan uploaded.
15/04/2025: The following changes have been made:
1. St Thomas' Hospital was removed from the study's participating centres, and South Buckinghamshire NHS Trust was replaced with Stoke Mandeville Hospital.
2. Queen Elizabeth Hospital, Royal Victoria Infirmary, University Hospital of North Durham, Peterborough City Hospital, Addenbrookes Hospital, North Tyneside General Hospital, Lister Hospital, Hull Royal Infirmary, John Radcliffe Hospital, Forth Valley Royal Hospital, Royal Derby Hospital, Morriston Hospital, Chelsea & Westminster Hospital, Queen Victoria Hospital NHS Foundation Trust, Sunderland Royal Hospital, and The Royal London Hospital were added to the study's participating centres.
25/06/2024: The recruitment end date was changed from 31/07/2024 to 30/04/2025.
29/08/2023: The following changes have been made:
1. The ethics approval has been added.
2. The recruitment start date has been changed from 01/03/2023 to 23/08/2023.
3. Wythenshawe Hospital and Queen Elizabeth Hospital have been removed from the study participating centres and South Buckinghamshire NHS Trust and St George's University Hospitals NHS Foundation Trust have been added.
