Evidence map›Paper›PMID 41121267›Full record

ArticleTrials2025

Clinical and cost-effectiveness of flexor digitorum profundus (FDP) versus FDP and flexor digitorum superficialis (FDS) repair for complete zone 2 flexor tendon injuries (FLARE): protocol for a randomised controlled trial.

Emma Reay, Joy Adamson, Lisa Newington, Kalpita Baird, Fraser Wiggins, Karen Glerum-Brooks, Liz Cook, Ann Hewison, Catherine Hewitt, Satwinder Hira and 14 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Emma ReaySouth Tees Academic Centre for Surgery, The James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW, UK.
Joy AdamsonYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Lisa NewingtonBarts Bone and Joint Health, Blizard Institute, Queen Mary University of London, 4 Newark Street, London, E1 2AT, UK.
Kalpita BairdYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Fraser WigginsYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Karen Glerum-BrooksYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Liz CookYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Ann HewisonYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Catherine HewittYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Satwinder HiraFrimley Health NHS Foundation Trust, Wexham Park Hospital, Wexham Street, Slough, Berkshire, SL2 4HL, UK.
David HolmesWirral University Teaching Hospital NHS Foundation Trust, Arrowe Park Hospital, Arrowe Park Road, Birkenhead, Wirral, CH49 5PE, UK.
Lucksy KottamSouth Tees Academic Centre for Surgery, The James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW, UK.
Jennifer C E LaneBarts Bone and Joint Health, Blizard Institute, Queen Mary University of London, 4 Newark Street, London, E1 2AT, UK.
Jinshuo LiYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Laura MandefieldYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Emma MoattYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Steve ParrottYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Amar RanganSouth Tees Academic Centre for Surgery, The James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW, UK.
Jeremy RodriguesWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
Arabella ScantleburyYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Ryckie G WadeLeeds Institute for Medical Research, University of Leeds, Leeds, LS9 7TF, UK.
Michelle WatsonYork Trials Unit, Department of Health Sciences, Faculty of Science, University of York, York, YO10 5DD, UK.
Justin C R WormaldSurgical Interventional Trials Unit, Nuffield, Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences , Botnar Research Centre, Old Road, Headington, Oxford, OX3 7LD, UK.
Matthew D GardinerSurgical Interventional Trials Unit, Nuffield, Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences , Botnar Research Centre, Old Road, Headington, Oxford, OX3 7LD, UK. matthew.gardiner@nhs.net.ORCID http://orcid.org/0000-0002-8058-4186

Funding

Health Technology Assessment Programme NIHR133784
6 · The paper itself

Abstract

backgroundFlexor tendon injuries are common and lead to over 3200 admissions for specialist surgical repair annually in England and Wales. Surgery to repair complete division of both flexor tendons in zone 2 of the hand is technically challenging. There is variation in surgical repair techniques with no high-quality evidence to support decision-making. In particular, the decision to repair both tendons or just one is contested. Surgery is followed by specialist rehabilitation, which takes at least 12 weeks. The resulting hand function can impact the patient's income, life satisfaction, well-being, self-worth, and mental health. The FLARE trial aims to determine the clinical and cost-effectiveness of repairing the flexor digitorum profundus (FDP) alone (intervention) versus the repair of both FDP and flexor digitorum superficialis (FDS) (control) for the treatment of complete zone 2, single-digit flexor tendon injuries in adults.

methodsA multi-centre, two-arm, blinded, non-inferiority, parallel group, randomised controlled trial with an internal pilot, economic evaluation, and nested qualitative study. Participants will be randomised 1:1 to receive either repair of FDP alone or repair of both FDP and FDS. A total of 310 adults will be recruited from NHS Trusts within the UK, randomised at surgery, and followed up within 7 days, 6 weeks, 3 months, and 6 months post-randomisation. The primary outcome measure is the patient evaluation measure (PEM) administered 6 months post-randomisation. Secondary outcomes include the PEM at other timepoints, Patient Related Wrist/Hand Evaluation (PRWHE), EuroQol 5 Dimensions Score (EQ-5D-5L), complications, total range of motion, grip strength, adherence to splint and therapy regimens, work outcomes, treatment and outcome satisfaction, and healthcare resource use. DISCUSSION: FLARE is designed with sufficient power and rigour to provide evidence on the clinical and cost-effectiveness of two surgical repair methods for single-digit, complete zone 2 flexor tendon injuries in adults. If the repair of FDP alone is as beneficial to the patient as the repair of FDP and FDS, this could save the NHS £1.8 million annually through reduced time and material costs. Furthermore, the trial findings will facilitate better shared decision-making discussions between clinicians and patients.

trial registrationISRCTN 10918157. Prospectively registered: 12.01.2023.

Indexed as

Finger InjuriesHealth Care CostsOrthopedic ProceduresTendon InjuriesTendonsCost-Benefit AnalysisEnglandEquivalence Trials as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicRecovery of FunctionTime FactorsTreatment OutcomeFingerFlexor tendonHand therapyHand traumaOrthopaedic surgeryPatient evaluation measurePlastic surgeryRandomised controlled trialRehabilitationSurgery

Identifiers

PMID41121267
PMCPMC12539191

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.