Sling immobilisation compared with surgery in the management of adults with a displaced fracture of the distal clavicle (DIDACT): a multi-centre, pragmatic, parallel group, non-inferiority, randomised controlled trial
A radiological diagnosis of a displaced fracture of the distal clavicle that does not involve the acromioclavicular joint.
Current interventions as of 18/09/2025: DIDACT is a two-arm, pragmatic, multi-centre, randomised, non-inferiority trial with parallel groups, allocated on a 1:1 ratio using random permuted blocks of random block size and stratified by age (<65 or ≥65 years). There will be a 12 month internal pilot to assess the assumptions about site set up and recruitment. The trial will include a full health economic evaluation. As with many surgical trials, it will not be feasible to blind patients, surgeons, or outcome assessors to the treatment allocation. Intervention: Sling Immobilization: upper limb support with a sling, typically for 2 to 4 weeks, followed by surgical fixation if symptomatic non-union of the fracture typically at the 3 month follow-up Comparator: Surgical Fixation: Locking plate fixation, with or without coracoclavicular (CC) sling, or CC reconstruction alone. _____ Previous interventions: DIDACT is a two-arm, pragmatic, multi-centre, randomised, non-inferiority trial with parallel groups, allocated on a 1:1 ratio using random permuted blocks of random block size and stratified by age (<65 or ≥65 years). There will be a 12 month internal pilot to assess the assumptions about site set up and recruitment. The trial will include a full health economic evaluation. As with many surgical trials, it will not be feasible to blind patients, surgeons, or outcome assessors to the treatment allocation. Intervention: Surgical Fixation: Locking plate fixation, with or without coracoclavicular (CC) sling, or CC reconstruction alone. Comparator: Sling Immobilization: upper limb support with a sling, typically for 2 to 4 weeks, followed by surgical fixation if symptomatic non-union of the fracture typically at the 3 month follow-up
1. Aged 18 years or older. 2. Displaced extra-articular (outside the joint) fracture of the distal clavicle based on routine radiographic assessment, with or without polytrauma. 3. Able and willing to give consent.
1. The index injury is >21 days. 2. An upper extremity fracture both more proximal or distal to the same affected shoulder e.g. floating shoulder. 3. The fracture is open. 4. The fracture is complicated by local tumour deposits. 5. The fracture is associated with a nerve palsy or vessel injury. 6. Comorbidities precluding surgery or anaesthesia. 7. Unable or unwilling to give consent. 8. Must not be related to any member of the local study team.