RESUMEN
Background: Following the repair of a mixed peripheral nerve, functional recovery requires successful nerve regeneration across the repair site and, eventually, reinnervation of distal targets. Reliably determining a failing nerve repair so that revision may be performed before irreversible muscle atrophy remains a challenge in peripheral nerve surgery. This study aimed to ascertain whether any commonly used clinical examination tests during surveillance after nerve repair can detect a failing repair and prompt earlier salvage intervention. Methods: A prospective observational cohort study was performed to evaluate commonly used clinical determinants of neuron regeneration that may provide early surrogate recovery measures. Sequential cutaneous thermography was used to identify temperature differences between denervated and normal skin in the hand operated on, with the contralateral hand as a control. Results: Six out of nine patients completed between 6 and 18 months of follow-up. Tinel sign progression was observed in all subjects. Tinel progression rate was associated with motor and sensory Medical Research Council grade. The delta temperature was calculated to document the size and direction of any temperature differentials in the hand detected by thermography, but we did not have sufficient data to calculate any correlations with motor and sensory Medical Research Council grade. Conclusions: Specifically, the progression of Tinel sign is associated with recovery measured by progression of the British Medical Research Council motor and sensory grades. The use of thermographic imaging demonstrates that there is a difference in temperature between an injured and noninjured nerve. Future studies could investigate to what extent thermographic imaging predicts final nerve repair outcomes.
RESUMEN
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.