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

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.

Relative motion flexion following zone I-III flexor tendon repair: Concepts, evidence and practice.

STUDY DESIGN: Narrative review and case series. INTRODUCTION: The relative motion approach has been applied to rehabilitation following flexor tendon repair. Positioning the affected finger(s) in relatively more metacarpophalangeal joint flexion is hypothesized to reduce the tension through the repaired flexor digitorum profundus by the quadriga effect. It is also hypothesized that altered patterns of co-contraction and co-inhibition may further reduce flexor digitorum profundus tension, and confer protection to flexor digitorum superficialis. METHODS: We reviewed the existing literature to explore the rationale for using relative motion flexion orthoses as an early active mobilization strategy for patients after zone I-III flexor tendon repairs. We used this approach within our own clinic for the rehabilitation of a series of patients presenting with zone I-II flexor tendon repair. We collected routine clinical and patient reported outcome data. RESULTS: We report published outcomes of the clinical use of relative motion flexion orthoses with early active motion, implemented as the primary rehabilitation approach after zone I-III flexor digitorum repairs. We also report novel outcome data from 18 patients. DISCUSSION: We discuss our own experience of using relative motion flexion as a rehabilitation strategy following flexor tendon repair. We explore orthosis fabrication, rehabilitation exercises and functional hand use. CONCLUSIONS: There is currently limited evidence informing use of relative motion flexion orthoses following flexor tendon repair. We highlight key areas for future research and describe a current pragmatic randomized controlled trial.

A Review of Outcome Reporting Practices after Flexor Tendon Repair in Zones 1 and 2.

Background: Outcome reporting following flexor tendon repair has historically concentrated on range of movement. Recently, there has been an increase in the use of patient-reported outcome measures (PROMs). At present, there is no agreed set of outcomes to report following flexor tendon repair. The aim of this study is to review outcome reporting practices after flexor tendon repair in zones 1 and 2. Methods: A search of Ovid MEDLINE, Ovid EMBASE and Cumulative Index to Nursing and Allied Health Literature (CINAHL) between 1 January 1980 and 31 December 2019 was performed to identify the studies that reported outcomes following the repair of flexor tendons in zones 1 and 2. Study characteristics and data with regard to the reporting of eight outcome domains was extracted: functional outcome (quantitative), functional outcome (subjective), activities of daily living (ADL), satisfaction/quality of life, post-treatment recovery, resources, aesthetics and safety. Results: A total of 94 out of 4,118 articles identified were included in the review. All studies reported range of motion using 17 different methods of measurement. Eleven studies defined measurement methods incorrectly or unclearly. Only 16 studies reported PROMs, with only one reporting data on assessment of quality of life. Eighteen studies reported time away from employment. Minimal data on resource utilisation and aesthetics were included. Conclusion: This review highlights wide heterogeneity and paucity of data reporting clinical outcomes of flexor tendon surgery. The development of a core outcome set that would ensure essential outcomes are correctly defined, measured and reported is required. Level of Evidence: Level IV (Prognostic).