The Scandinavian Displaced Lateral Clavicle Trial (ScanDiLaC)

Uppsala University

Status: Enrolling

Conditions: Clavicle Fracture

Treatments: Procedure: Surgical treatment; Procedure: Simple Sling and Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06981065

2025-01097-01

Details and patient eligibility

About

A multicentre multinational RCT to investigate whether non-surgical treatment is non-inferior to surgical treatment for displaced extraarticular lateral clavicle fractures in adults.

Full description

The aim of this study is to investigate whether non-surgical treatment is non inferior to surgical treatment for displaced lateral clavicle fractures with regards to functional outcome measured with different patient-reported outcome measures. Patients aged 18-65 years will be randomized to non-surgical or surgical (pragmatic) treatment. The primary outcome is the Disabilities of Arm Hand and Shoulder (DASH) score at 1 year.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- Displaced extraarticular lateral clavicle fracture (type II or V according to the modified Neer classification)

Exclusion criteria

• Pathological fracture
• Open fracture
• Neurovascular injury
• Same-time fracture in the upper extremity
• Polytrauma
• Contraindications to surgery and/or anesthesia
• Unable to give informed consent
• Inability to complete follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Non-surgical

Experimental group

Description:

Non-surgical treatment with a simple sling and physiotherapy. Cross-over option at 6 weeks if signs of symptomatic delayed union, non-decreasing pain, and patient requests surgery

Treatment:

Procedure: Simple Sling and Physiotherapy

Surgical

Active Comparator group

Description:

Surgical treatment with plate and screws

Treatment:

Procedure: Surgical treatment