Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs

Bamford, Emma; Berntsson, Hannah; Beale, Suzanne; Desoysa, Lauren; Dias, Joseph; Hamer-Kiwacz, Sienna; Hind, Daniel; Johnson, Nick; Loban, Amanda; Molloy, Kaye; Morvan, Emma; Rombach, Ines; Selby, Anna; Thokala, Praveen; Turtle, Chris; Walters, Stephen; Drummond, Avril

Abstract

Background: Without surgical repair, flexor tendon injuries do not heal and patients’ ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There are currently three custom-made splints used in the rehabilitation of zone I/II flexor tendon repairs, each with different assumed harm/benefit profiles: the dorsal forearm and hand-based splint (long), the Manchester short splint (short), and the relative motion flexion splint (mini). There is, however, no robust evidence as to which splint, if any, is most clinical or cost effective. The Flexor Injury Rehabilitation Splint Trial (FIRST) was designed to address this evidence gap. Methods: FIRST is a parallel group, superiority, analyst-blind, multi-centre, individual participant-randomised controlled trial. Participants will be assigned 1:1:1 to receive either the long, short, or mini splint. We aim to recruit 429 participants undergoing rehabilitation following zone I/II flexor tendon repair surgery. Potential participants will initially be identified prior to surgery, in NHS hand clinics across the UK, and consented and randomised at their splint fitting appointment post-surgery. The primary outcome will be the mean post-randomisation score on the patient-reported wrist and hand evaluation measure (PRWHE), assessed at 6, 12, 26, and 52 weeks post randomisation. Secondary outcome measures include blinded grip strength and active range of movement (AROM) assessments, adverse events, adherence to the splinting protocol (measured via temperature sensors inserted into the splints), quality of life assessment, and further patient-reported outcomes. An economic evaluation will assess the cost-effectiveness of each splint, and a qualitative sub-study will evaluate participants’ preferences for, and experiences of wearing, the splints. Furthermore, a mediation analysis will determine the relationship between patient preferences, splint adherence, and splint effectiveness. Discussion: FIRST will compare the three splints with respect to clinical efficacy, complications, quality of life and cost-effectiveness. FIRST is a pragmatic trial which will recruit from 26 NHS sites to allow findings to be generalisable to current clinical practice in the UK. It will also provide significant insights into patient experiences of splint wear and how adherence to splinting may impact outcomes. Trial registration: ISRCTN: 10236011

• Journal Article Type: Article
• Acceptance Date: Feb 23, 2024
• Online Publication Date: Mar 16, 2024
• Publication Date: Mar 16, 2024
• Deposit Date: May 16, 2024
• Publicly Available Date: May 16, 2024
• Journal: Trials
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 25
• Issue: 1
• Article Number: 193
• DOI: https://doi.org/10.1186/s13063-024-08013-z
• Keywords: Randomised controlled trial, Physiotherapy, Finger flexor tendon repair, Occupational therapy, Surgery, Splinting, Finger flexor tendon rupture, Rehabilitation, Hand therapy
• Public URL: https://nottingham-repository.worktribe.com/output/32736677
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08013-z
• Additional Information: Received: 14 December 2023; Accepted: 23 February 2024; First Online: 16 March 2024; : ; : Ethics approval for this RCT was sought and received from the South West – Cornwall and Plymouth Research Ethics Committee on 7 June 2022 (REC ref: 22/SW/0074). Written informed consent will be obtained from all RCT participants.; : Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are attached as InternalRef removed.; : The authors declare that they have no competing interests.