Prospective randomised controlled trial comparing three splints for finger flexor tendon repairs (FIRST study)
Injuries and accidents
The trial will be conducted in approximately 20 hospitals. Patients listed for, or who have undergone surgical repair of zone I/II flexor tendons will be identified from hand clinics/ theatre or hand therapy services and provided with study information. Potentially eligible patients will be given information sheets by delegated site staff and invited to consent at their first clinic visit post-surgery. Recruitment posters and/or business cards directing potential participants to the study website, where the PIS will be available online, will also be available in hand clinics at participating sites. Participants will be randomised to receive either the long, short, or mini splint and will be followed up at 6, 12, 26 and 52 weeks post-randomisation. All follow-up visits will take place in the clinic, with the exception of the 52-week visit which will be done remotely. The Patient-Reported Wrist and Hand Evaluation (PRWHE) questionnaire (primary outcome) will be completed at each follow-up visit. The PRWHE is a 15-item patient-reported outcome for assessing wrist and hand pain/disability on a scale of 0 to 100. The primary outcome will be the mean post-randomisation total PRWHE score. Participants will also be asked to complete questionnaires about their hand and wrist function, general health, quality of life and work productivity and activity. Participants will be asked about any adverse events at each follow-up visit. Range of movement and grip strength will be assessed by site staff blinded to treatment allocation, range of movement at baseline, 6, 12 and 26 weeks and grip strength at 12 and 26 weeks. The project also includes a process evaluation sub-study, which will explore how patient preferences for splint attributes and patient-reported acceptability of splints influence splint adherence. This aspect will involve a survey on participant preferences (stated preferences) at baseline, and on 'revealed' preferences and acceptability of splints at 6 weeks. To
1. Aged 16 years old and over 2. Primary repair of zone I/II finger flexor tendon 3. Surgical repairs according to BSSH guidelines
1. Patients with associated fractures requiring fixation or additional splintage 2. Tendon lacerations involving 3 or more fingers 3. Revascularization surgery and/or digital nerve reconstructions requiring a nerve graft 4. Presented for treatment more than 3 weeks following the original injury 5. Patients unable to consent or comply with the rehabilitation regime, for example, due to cognitive, psychological or physical disabilities 6. Co-enrolment in another hand trial