Clinical trial NCT06981065: The Scandinavian Displaced Lateral Clavicle Trial
Official title: The Scandinavian Displaced Lateral Clavicle Trial (ScanDiLaC) - A Multicentre, Pragmatic, 12-Month, Non-inferiority, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clavicle Fracture
Keywords: Displaced lateral clavicle fracture
Non-surgical
Surgical
PROMs
Health economy
Non-inferior
Complications
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallell with cross-over option in non-surgical arm
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Disabilites of the Arm, Shoulder and Hand (DASH)
timeFrame: 1 year
Secondary outcomes:
measure: Disabilites of the Arm, Shoulder and Hand (DASH)
timeFrame: Pre-injury, 6 weeks, 3 months, 6 months, 2 years, 5 years
measure: Nottingham Clavicle Score (NCS)
timeFrame: 6 weeks, 3 months, 6 months, 1, 2, 5 years
measure: University of California, Los Angeles (UCLA) Activity scale
timeFrame: Pre-injury, 6 weeks, 3 months, 6 months, 1 years
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
timeFrame: Pre-injury, 6 weeks, 3 months, 6 months, 1, 2, 5 years
measure: Visual Analog Scale (VAS) for pain
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1, 2, 5 years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Fredrikstad
country: Norway
facility: Østfold Hospital Trust
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Malmö
country: Sweden
facility: Skane University Hospital
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Umeå
country: Sweden
facility: Norrlands University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hopsital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Uppsala University Hospital and Uppsala University
name: Olof Wolf, Associate Professor, MD
role: PRINCIPAL_INVESTIGATOR
References: