Title: Prospective randomised controlled trial comparing three splints for finger flexor tendon repairs (FIRST study)
Funder: Department of Health and Social Care

Abstract: Background to the research: Flexor tendons attach to the muscles in our forearms and give us the ability to bend our fingers. In the UK, more than 7,000 people a year cut their flexor tendons. Without surgery to repair the tendons, the fingers would never bend and our hands would become useless. Following surgery, a ‘made to measure’ splint is needed to prevent the repaired tendon from re-rupturing. However, people who have had this operation have told us that wearing a splint is awkward and often means they can not work. They also told us that sometimes they do not wear their splint at all. There are currently three splints available on the NHS: long, short and mini. We do not know which of the three splints is best. _x000D_ _x000D_ Aims: We want to know, which splint gives people the best chance of getting back their normal hand use, what is it like to wear each splint, if people wear these as instructed, and whether one splint is better value for money. _x000D_ _x000D_ Design and methods used: We will recruit 429 patients from 20 hospitals who have had their flexor tendons repaired. They will be randomised into 3 groups and given either the long, short or mini splint following their surgery. They will be monitored for a year. We will ask questions about their hand and wrist use and how long they had off work. We will measure how much they can move their hand and how strong their hand is. We will also ask if they have any pain in their hand or wrist, or had any other troubles because of their injury. _x000D_ _x000D_ We will put heat sensors in each splint which will monitor how much they are wearing their splint and each patient will be surveyed to find out what aspects of wearing the splint are important to them. Alongside this, we will interview 20 patients and ask them what it was like to wear the splint, we will ask if they removed their splint and why this was. _x000D_ _x000D_ We will investigate the number of appointments people have had and if they needed any extra operations or treatments to fix their hand. All of this information will be used to understand which splint is best clinically and provides the best value for money. _x000D_ _x000D_ Patient and public involvement: Ten people who have had a flexor tendon injury told us their experiences of wearing the different splints. They told us what daily activities were a problem for them and how they thought we should measure this in the study. They wanted us to ask study participants how easy or hard it was to do daily tasks, about how comfortable the splint was and if they have pain or problems with their hand in cold weather. This group of ten people will keep working with us during this study to help us answer these questions. _x000D_ _x000D_ Dissemination: We will report our results in high impact journals and present our results at UK and worldwide scientific meetings. We will use our professional links to inform hand therapy clinical guidelines. We will share videos and posts on social media so that everyone who has or works with this injury will know which splint is best, under what circumstances and why.

Lay abstract: Research question: How, and by how much, is any splint more clinically effective and cost-effective than others for rehabilitation following repair of Zone I/II finger flexor tendons?_x000D_ _x000D_ Background: After surgery, repaired flexor tendons must be protected with a splint, while allowing finger movement to prevent stiffness. Three custom-made splints are available on the NHS: ‘long’ (restricts wrist/fingers); ‘short’ (restricts hand); ‘mini’ (restricts fingers). Wearing splints prevents normal hand movement, restricts activities of daily living and affects return to work. However, we do not know which splint is best and poor splint adherence can lead to newly repaired tendons rupturing. _x000D_ _x000D_ Aims: To investigate splint clinical and cost effectiveness, and mediators of effectiveness._x000D_ _x000D_ Objectives: An analyst-blind parallel group RCT detecting any superiority in patient-reported pain and function over one year. Process evaluation showing how patient values and adherence mediates effectiveness. Parallel economic evaluation determining cost-effectiveness._x000D_ _x000D_ Methods: RCT (n=429) at 20 hospitals, comparing the three splints, powered to show a 6-point difference in 100-point Patient-Rated Wrist and Hand Evaluation survey instrument at 6, 12, 26 and 52 weeks post-randomisation. Eligibility: aged 16+ years; primary repair of zone I/II finger flexors according to BSSH guidelines. Not eligible: fractures requiring fixation; lacerations involving 3+ fingers; need for nerve graft; 3+ weeks elapsed since surgery. Secondary outcomes include upper limb function, range of movement, grip strength, activity impairment, quality of life, complications, resource use and return to work. Process evaluation will collect quantitative acceptability and splint compliance data on all patients, with nested semi-structured interviews with 20 participants to inform a structural equation model to understand how context moderates adherence and adherence mediates pain and function. Parallel economic evaluation with the clinical trial will estimate incremental cost-effectiveness ratios. Long-term cost-effectiveness modelling will estimate the lifetime QALYs and costs._x000D_ _x000D_ Timelines for delivery: M1-8 set-up; M9-16 internal RCT pilot, M17 stop/go assessment, M9-23 RCT main trial recruitment, M24-35 follow-up only; M36-41: closedown and analysis._x000D_ _x000D_ Anticipated impact and dissemination: Clinicians and patients will know if any splint is superior and understand the harms, benefits and acceptability of each. Results will be presented in high impact journals and at key international conferences and will contribute to updating hand therapy guidelines and clinical education.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS