Efficacy of the Manchester Short Splint versus traditional dorsal splint for rehabilitation of Zone II flexor tendon repairs: study protocol for a randomized controlled trial

Abstract

Background: A previously reported audit of use of the Manchester Short Splint versus the traditional long dorsal forearm splint for rehabilitation of zone II flexor tendon repairs suggested that patient outcomes were enhanced by use of the short splint. Specifically, there was less flexion contracture at the proximal interphalangeal joints at 6 and 12 weeks with greater final range of motion (Strickland assessment). Importantly, there was no evidence of excess tendon ruptures complicating use of the short splint.Methods: The present study is designed as a single-centre randomized controlled trial to compare the two splints [Clinical Evidence Level 2 as patient and treating therapists are aware of which splint is in use]. The study is framed to demonstrate superiority of the short splint intervention over the long splint. Surgery is standardized with respect to the type of repair used. Inclusion criteria for the trial include single finger flexor tendon injury of zone II with up to one but not two simultaneous digital nerve injuries operated on within 4 days of the injury date. Exclusions include children, more complex injuries, those unable to give consent or otherwise co-operate with the trial protocol. Patients are recruited at their first hand therapy visit having been provided with information about the trial by one of the Site Investigators during their hospital admission. The consenting patient is randomized into one of two splint groups. Assessments at 6 and 12 weeks include range of interphalangeal joint motion (TAM), patient reported outcomes (PEM, Quick Dash, pain scales) and grip strength (12 weeks only). Adverse events related and unrelated are documented in line with GCP protocols and patients managed according to clinical indications.Discussion: The present study aims to determine the efficacy of the short splint versus the traditional splint in rehabilitation of Zone II flexor tendon repair. Previous work was in the form of an audit and it is clearly desirable that a more rigorous study is undertaken to address the efficacy or otherwise of the short splint in the context of a clinical trial and to inform development of a multi-centre study.Trial registration: ClinicalTrials.gov Identifier: NCT0385021021.2.19 Retrospectively registeredhttps://clinicaltrials.gov/ct2/results?cond=&term=NCT03850210&cntry=&state=&city=&dist= See website for WHO Trial Registration Data SetTrial Status: Recruitment of first patient 31.3.15. Recruitment completed 6.4.20 subsequent to first submission of manuscript 3.4.20. Study is ongoing for subsequent patient review and measurements as protocol for the subsequent 12 week period and will conclude 29.6.20.