Abstract
Introduction: Flexor tendon rehabilitation in zone II remains challenging due to the risk of complications such as tendon adhesions and rupture. A previously reported audit of the Manchester Short Splint demonstrated less flexion contracture at the proximal interphalangeal joints at 6 and 12 weeks with greater final range of motion compared with the traditional dorsal forearm splint, without increased tendon rupture. The present study describes the protocol for a randomized controlled trial designed to formally evaluate the short splint.
Methods: This single center randomized controlled trial allocates adults with a single Zone II flexor tendon repair to either a traditional dorsal forearm splint or the Manchester Short Splint. The study is framed to demonstrate superiority of the short splint intervention over the long splint. All tendon repairs use a standard four-strand core repair and epitendinous suture technique. 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. Outcomes are assessed at 6 and 12 weeks by a hand therapist blinded to allocation. The primary outcome is total active motion measured with a goniometer. Secondary outcomes include patient-reported measures (Patient Evaluation Measure, Disabilities of the Arm, Shoulder and Hand questionnaire, numerical pain scale) and grip strength at 12 weeks.
Discussion: The study protocol presented aims to evaluate the efficacy of the Manchester Short Splint compared with the traditional dorsal splint in the rehabilitation of Zone II flexor tendon repairs. Earlier observational work suggested potential benefit, but a rigorously designed randomized controlled trial is required to formally assess whether the short splint improves motion without increasing rupture risk. If superiority of the short splint is demonstrated, the findings could support a change in clinical rehabilitation practice and inform the design of a future multicenter trial.
Trial registration: ClinicalTrials.gov Identifier: NCT03850210 21.2.19 Retrospectively registered
https://clinicaltrials.gov/ct2/results?cond=&term=NCT03850210&cntry=&state=&city=&dist= See website for WHO Trial Registration Data Set
Trial Status: Recruitment of first patient 31.3.15. Recruitment completed 6.4.20. Study is ongoing for subsequent patient review and measurements as protocol for the subsequent 12-week period and will conclude 29.6.20.