A multicentre, randomized, pragmatic, parallel group, non-inferiority trial to compare the clinical and cost-effectiveness of sling immobilization versus surgery in the management of adults with a displaced fracture of the distal clavicle : protocol for the DIDACT randomized controlled trial.

Abstract

Aims: Fractures of the clavicle primarily occur in young males and constitute 2.6% to 5% of all fractures in adults. Distal clavicle fractures, where the outer end of the collarbone breaks, account for 20% to 25% of all clavicle fractures. These fractures can be called displaced if the ligaments connecting the collarbone to the shoulder blade (coracoclavicular complex) rupture. Such displaced fractures (Neer's type II and V) are currently treated with an operation involving fracture fixation or with sling immobilization. This protocol describes a randomized controlled trial that aims to evaluate the clinical and cost-effectiveness of these two types of treatment which are used for displaced distal clavicle fractures.

Methods: The DIsplaced DistAl Clavicle Fracture Trial (DIDACT) is a pragmatic, parallel, two-arm individually randomized non-inferiority trial of 214 adult patients with a radiologically confirmed diagnosis of a displaced distal clavicle fracture. Participants will be randomly allocated on 1:1 basis to surgery with locking plate fixation (with or without coracoclavicular (CC) sling, or CC reconstruction alone) or sling immobilization. In the sling immobilization group, if symptomatic nonunion occurs, participants would be offered surgical fixation (typically at the three-month follow-up). The primary outcome and endpoint will be the self-reported Disabilitities of the Arm, Shoulder and Hand questionnaire (DASH) at 12 months. The DASH will also be collected as a secondary outcome at baseline, six weeks, three, and six months after randomization. Other secondary outcomes include shoulder pain, EuroQol five-dimension five-level questionnaire (EQ-5D-5L), complications (e.g. infections, reoperations), fracture healing, healthcare costs, patient treatment preferences, satisfaction with appearance of their shoulder, sensitivity or pain to touch, and range of motion.

Conclusion: There is uncertainty around whether a sling immobilization pathway is non-inferior to surgery and which of these two treatments is cost-effective. The DIDACT trial is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury.