Eligibility

Local study conflicts

• Cannot be co-enrolled to any other study which is looking at upper limb outcomes

Inclusion Criteria:

• Aged ≥18 years
• Displaced extraarticular (outside the joint) fracture of the distal clavicle including polytrauma
• Able and willing to give consent

Exclusion Criteria:

• The index injury is >21 days
• An upper extremity fracture that is both more proximal or distal to the affected shoulder e.g. floating shoulder
• The fracture is open
• The fracture is complicated by local tumour deposits
• The fracture is associated with a nerve palsy or vessel injury
• Comorbidities precluding surgery or anaesthesia
• Unable or unwilling to give consent
• Must not be related to any member of the local study team

If the patient seems eligible:

• Inform the patient that they may be eligible for a research study
• Gain verbal agreement in principle before proceeding. Explain:
• Taking part in research is likely to improve the quality of their care
• Risks are carefully controlled - research is safe
• Explain the uncertainty that exists with respect to treatment of their condition
• If they change their mind they can withdraw their participation at any point


• Please be mindful of discussion treatment options (i.e. having surgery or wearing a sling) to manage patient expectations before being approached about DIDACT by the study team

Step-by-Step Guide to Recruitment:

In standard working hours

• The research nurse team aims to be available Monday to Friday 08.00 - 16.00.
• Contact them via Secure Chat: Research Delivery Team

Confirming eligibility

• Eligibility can only be confirmed by medical team on delegation log
• Mr Niel Kang, consultant orthopaedic / trauma surgeon, is the PI and will know which members of staff are delegated this role

Gaining formal consent

1. Patients identified via Virtual Fracture Clinic or trauma list
2. Clinical team to have initial conversation with the patient and ask if details can be passed onto the research nurse team . If consent for contact for research is documented on EPIC then research nurse will make the first approach. This will usually be done via phone prior to upper limb clinic appointment.
3. Research nurse team to send out PIS and follow up to see if they are interested.
4. At clinic appointment, delegated medical team member to document eligibility directly onto REDCAP
5. Delegated Research nurses will receive consent and complete all baseline questionnaires

Randomisation procedure

• Research Nurse team will complete randomisation and inform clinical teams of allocation.

Carrying out the intervention:

• If randomised to surgery, the treating surgeon will organise as per standard of care.
• Following randomisation, all patients will receive a sling care leaflet and offered appropriate physiotherapy as per standard care.

Disposition and follow-up:

• Follow-up questionnaires will be completed with the patient by the central team
• Face to face follow up at 3 months and 12 months for imaging purposes

Links for further information:

Link to trial site