The Scandinavian Displaced Lateral Clavicle Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Simple Sling and Physiotherapy, Surgical treatment.
- Who it may be relevant to
- Registry conditions: Clavicle Fracture. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, Finland, Norway, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Scandinavian Displaced Lateral Clavicle Trial (ScanDiLaC) - A Multicentre, Pragmatic, 12-Month, Non-inferiority, Randomized Controlled Trial
Overview
A multicentre multinational RCT to investigate whether non-surgical treatment is non-inferior to surgical treatment for displaced extraarticular lateral clavicle fractures in adults.
Detailed 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.
Interventions
- Procedure Simple Sling and Physiotherapy
Non-surgical treatment with a simple sling and physiotherapy according to standardized program. - Procedure Surgical treatment
Surgical treatment with plate and screws (lateral clavicle plate, clavicle plate or hook plate with/without coracoclavicular fixation).
Primary outcome measures
- Disabilites of the Arm, Shoulder and Hand (DASH) [Time frame: 1 year]
Secondary outcome measures (5)
- Disabilites of the Arm, Shoulder and Hand (DASH) [Time frame: Pre-injury, 6 weeks, 3 months, 6 months, 2 years, 5 years]
- Nottingham Clavicle Score (NCS) [Time frame: 6 weeks, 3 months, 6 months, 1, 2, 5 years]
- University of California, Los Angeles (UCLA) Activity scale [Time frame: Pre-injury, 6 weeks, 3 months, 6 months, 1 years]
- EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire [Time frame: Pre-injury, 6 weeks, 3 months, 6 months, 1, 2, 5 years]
- Visual Analog Scale (VAS) for pain [Time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2, 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 8 centers
- Kalmar Regional Hospital — Kalmar
- Linköping University Hospital — Linköping
- Skane University Hospital — Malmö
- Örebro University Hospital — Örebro
- Danderyd Hospital — Stockholm
- Stockholm South Hospital — Stockholm
- Norrlands University Hospital — Umeå
- Uppsala University Hopsital — Uppsala
Denmark · 1 center
- Odense University Hospital — Odense
Finland · 1 center
- Tampere University Hospital — Tampere
Norway · 1 center
- Østfold Hospital Trust — Fredrikstad
Publications
- Christersson P, Karimi D, Gronhaug K, Launonen A, Brorson S, Frihagen F, Viberg B, Hailer N, Wolf O. The Scandinavian Displaced Lateral Clavicle trial (ScanDiLaC): a study protocol for a randomized clinical trial. Trials. 2026 Jun 13;27(1):438. doi: 10.1186/s13063-026-09844-8. PMID 42288927
Identifiers
NCT: NCT06981065 · 2025-01097-01