The Scandinavian Displaced Lateral Clavicle Trial

NCT06981065 | Recruiting DMC

• 1 other identifier: 2025-01097-01
• Study Type: interventional
• Target: 96
• Locations: 4 countries
• Sites: 11

Brief Summary

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

Conditions

Clavicle Fracture

Keywords

Displaced lateral clavicle fracture; Non-surgical; Surgical; PROMs; Health economy; Non-inferior; Complications

Outcome Measures

Primary Outcomes (1)

• Disabilites of the Arm, Shoulder and Hand (DASH)

  A 30-item patient-reported outcome measure concerning shoulder, arm and hand function, with two additional 4-item modules concerning work and sports function. Min: 0 Max: 100. 0 representing no disability and 100 representing the most severe disability. A DASH score of 50 or more is often considered a cutoff for the presence of severe disability, while 20 or more suggests a medium level of disability.

  1 year

Secondary Outcomes (5)

• Disabilites of the Arm, Shoulder and Hand (DASH)

  Pre-injury, 6 weeks, 3 months, 6 months, 2 years, 5 years

• Nottingham Clavicle Score (NCS)

  6 weeks, 3 months, 6 months, 1, 2, 5 years

• University of California, Los Angeles (UCLA) Activity scale

  Pre-injury, 6 weeks, 3 months, 6 months, 1 years

• EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire

  Pre-injury, 6 weeks, 3 months, 6 months, 1, 2, 5 years

• Visual Analog Scale (VAS) for pain

  Baseline, 6 weeks, 3 months, 6 months, 1, 2, 5 years

Study Arms (2)

Non-surgical

EXPERIMENTAL

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

Procedure: Simple Sling and Physiotherapy

Surgical

ACTIVE COMPARATOR

Surgical treatment with plate and screws

Procedure: Surgical treatment

Interventions

Simple Sling and Physiotherapy PROCEDURE

Non-surgical treatment with a simple sling and physiotherapy according to standardized program.

Non-surgical

Surgical treatment PROCEDURE

Surgical treatment with plate and screws (lateral clavicle plate, clavicle plate or hook plate with/without coracoclavicular fixation).

Surgical

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (11)

Odense University Hospital

Odense, Denmark

NOT YET RECRUITING

Tampere University Hospital

Tampere, Finland

NOT YET RECRUITING

Østfold Hospital Trust

Fredrikstad, Norway

NOT YET RECRUITING

Kalmar Regional Hospital

Kalmar, Sweden

RECRUITING

Linköping University Hospital

Linköping, Sweden

RECRUITING

Skane University Hospital

Malmo, Sweden

RECRUITING

Örebro University Hospital

Örebro, Sweden

RECRUITING

Danderyd Hospital

Stockholm, Sweden

RECRUITING

Stockholm South Hospital

Stockholm, Sweden

RECRUITING

Norrlands University Hospital

Umeå, Sweden

RECRUITING

Uppsala University Hopsital

Uppsala, Sweden

RECRUITING

MeSH Terms

Interventions

Physical Therapy Modalities; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Olof Wolf, Associate Professor, MD

  Uppsala University Hospital and Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pontus Christersson, MD, PhD Student

CONTACT

+46-18-6110000; pontus.christersson@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallell with cross-over option in non-surgical arm

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); NO (1); FI (1); SE (8)