Surgery or using a sling to support the arm for treating adults with a broken collarbone near the shoulder joint (displaced fracture of the distal clavicle)

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11981704

Enrollment

214

Registered

2023-07-31

Start date

2023-09-01

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A radiological diagnosis of a displaced fracture of the distal clavicle that does not involve the acromioclavicular joint. Injury, Occupational Diseases, Poisoning

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Patient-reported functional outcome measured by the Disability of Arm, Shoulder and Hand (DASH) at 12 months.	—

Secondary

Measure	Time frame
1. Patient-reported functional outcome measured by DASH score at 6 weeks, 3 and 6 months, and over 12 months 2. Shoulder pain measured using an 11-item unidimensional numerical rating scale of pain intensity in adults with 0 representing ‘no pain’ and 10 representing ‘worst imaginable pain’ in the past 24 hours at 6 weeks, 3, 6, and 12 months 3. Quality of life measured using EQ5D-5L at 6 weeks, 3, 6, and 12 months 4. Complications (e.g. infections, re-operations) measured using Centres for Disease Control (CDC) and Prevention definition for superficial and deep infection and record on a bespoke CRF rehospitalisation (e.g. repeat surgery to remove metalwork), nerve and skin problems and collected at 6 weeks, 3 and 12 months 5. Fracture healing (e.g. union, nonunion, malunion) measured using routine radiographs (typically anteroposterior and axial views) by the participating surgeons in clinic at 3 and 12 months 6. Patient preferences, satisfaction with the appearance of their shoulder/sensitivity or pain to touch, measured using a 5-item unidimensional Likert scale that ranges from ‘Very satisfied’ to ‘Very dissatisfied’ at 12 months and range of movement measured by participants using a diagram based questionnaire at 12 months	—

Measure

Time frame

1. Patient-reported functional outcome measured by DASH score at 6 weeks, 3 and 6 months, and over 12 months 2. Shoulder pain measured using an 11-item unidimensional numerical rating scale of pain intensity in adults with 0 representing ‘no pain’ and 10 representing ‘worst imaginable pain’ in the past 24 hours at 6 weeks, 3, 6, and 12 months 3. Quality of life measured using EQ5D-5L at 6 weeks, 3, 6, and 12 months 4. Complications (e.g. infections, re-operations) measured using Centres for Disease Control (CDC) and Prevention definition for superficial and deep infection and record on a bespoke CRF rehospitalisation (e.g. repeat surgery to remove metalwork), nerve and skin problems and collected at 6 weeks, 3 and 12 months 5. Fracture healing (e.g. union, nonunion, malunion) measured using routine radiographs (typically anteroposterior and axial views) by the participating surgeons in clinic at 3 and 12 months 6. Patient preferences, satisfaction with the appearance of their shoulder/sensitivity or pain to touch, measured using a 5-item unidimensional Likert scale that ranges from ‘Very satisfied’ to ‘Very dissatisfied’ at 12 months and range of movement measured by participants using a diagram based questionnaire at 12 months

—

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactSam Swan

sam.swan@york.ac.uk+44 (0)1904 328511

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026