FLexor repAir and REhabilitation (FLARE) Trial

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 March 2026

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

Mrs Liz Cook
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
Email	liz.cook@york.ac.uk

Dr Matthew Gardiner
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
Email	matthew.gardiner@nhs.net

Dr Emma Reay
Principal investigator

Trauma & Orthopaedics
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Phone	+44 (0)1642 850850
Email	emma.reay1@nhs.net

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England
• Northern Ireland
• Scotland
• Wales

Study participating centres

Results and Publications

Study outputs

Additional files

ISRCTN10918157_SAP_v1.0_28April2025.pdf

Statistical Analysis Plan

ISRCTN10918157_HEAP_v1.0_14April2025.pdf

Statistical Analysis Plan

Editorial Notes

24/10/2025: Publication reference added.
04/08/2025: Total final enrolment added. The date of final enrolment was changed from 31/03/2026 to 30/04/2025. The intention to publish date was changed from 31/01/2026 to 31/03/2026.
30/07/2025: The following changes were made to the study record:
1. The date of final enrolment was changed from 30/04/2025 to 31/03/2026.
2. The completion date was changed from 31/07/2025 to 31/03/2026.
3. Sunderland Royal Hospital and The Royal London Hospital were removed from the study participating centres.
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.