Clavicle FractureScanDiLaCNCT06981065
The Scandinavian Displaced Lateral Clavicle Trial
A study testing Simple Sling and Physiotherapy and Surgical treatment in people with Clavicle Fracture, run by Uppsala University at 11 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- Simple Sling and Physiotherapy and Surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 17 Sep 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Displaced extraarticular lateral clavicle fracture (type II or V according to the modified Neer classification)
Who cannot join
- 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 locations and contacts
11 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 4 countries
Sweden8 sites, 8 recruiting
- Recruiting
Kalmar Regional Hospital
Kalmar
Mats Ranbebo, +46103580000, mats.ranebo@regionkalmar.se
- Recruiting
Linköping University Hospital
Linköping
Johan Scheer, +46-10-1030000, johan.scheer@regionostergotland.se
- Recruiting
Skane University Hospital
Malmö
Jonas Nordin, +46-40-331000, jonas.nordin@skane.se
- Recruiting
Örebro University Hospital
Örebro
Per Fischer, +46-19-6021000, per.fischer@regionorebrolan.se
- Recruiting
Danderyd Hospital
Stockholm
Viktor Mili-Schmidt, +46-8-12355000, viktor.schmidt@ki.se
- Recruiting
Stockholm South Hospital
Stockholm
Johanna Rundgren, +46812361000, johanna.rundgren@regionstockholm.se
- Recruiting
Norrlands University Hospital
Umeå
Jonas Sundkvist, +46-90-7850000, jonas.sundkvist@umu.se
- Recruiting
Uppsala University Hopsital
Uppsala
Pontus Christersson, +46-18-6110000, pontus.christersson@uu.se
Denmark1 site, 1 recruiting
- Not yet recruiting
Odense University Hospital
Odense
Bjarke Viberg, bjarke.viberg@rsyd.dk
Finland1 site, 1 recruiting
- Not yet recruiting
Tampere University Hospital
Tampere
Antti Launonen, antti.launonen@loosi.ee
Norway1 site, 1 recruiting
- Not yet recruiting
Østfold Hospital Trust
Fredrikstad
Frede Frihagen, ffrihagen@gmail.com
About this study
Official title: The Scandinavian Displaced Lateral Clavicle Trial (ScanDiLaC) - A Multicentre, Pragmatic, 12-Month, Non-inferiority, Randomized Controlled Trial
A multicentre multinational RCT to investigate whether non-surgical treatment is non-inferior to surgical treatment for displaced extraarticular lateral clavicle fractures in adults.
Read the 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.
- Conditions
- Clavicle Fracture
- Being tested
- Simple Sling and Physiotherapy, Surgical treatment
- Keywords
- Displaced lateral clavicle fracture, Non-surgical, Surgical, PROMs, Health economy, Non-inferior, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple Sling and PhysiotherapyProcedure or surgery
Non-surgical treatment with a simple sling and physiotherapy according to standardized program.
Surgical treatmentProcedure or surgery
Surgical treatment with plate and screws (lateral clavicle plate, clavicle plate or hook plate with/without coracoclavicular fixation).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Simple Sling and Physiotherapy |
| Surgical | Active comparator | Surgical treatment with plate and screws Receives: Procedure: Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: Pre-injury, 6 weeks, 3 months, 6 months, 2 years, 5 years
Nottingham Clavicle Score (NCS)
A 10-item disease-specific PROM concerning functional outcome after injuries and diseases around the clavicle.
The minimum possible score is 20, and the maximum is 100. A higher score indicates better functional ability, while a lower score suggests greater functional disability. The NCS can be graded as excellent (80-100), good (60-79), fair (40-59), or poor (<40).
Measured: 6 weeks, 3 months, 6 months, 1, 2, 5 years
University of California, Los Angeles (UCLA) Activity scale
An activity scale measured in 10 levels. It ranges from 1 to 10, with 1 representing no physical activity and 10 representing regular participation in impact sports.
Measured: Pre-injury, 6 weeks, 3 months, 6 months, 1 years
EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Health-Related Quality of Life (HRQoL) measured in 5 Levels. The minimum and maximum possible outcomes for EQ-5D-5L index scores are -0.573 and 1, respectively. The minimum value represents a health state considered worse than death, while 1 represents full health.
Measured: Pre-injury, 6 weeks, 3 months, 6 months, 1, 2, 5 years
Visual Analog Scale (VAS) for pain
Pain measure by visual analog scale in 11 levels. Minimum 0 and maximum 10. Higher figure indicates more pain. 10 is maximum pain.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1, 2, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start17 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallell with cross-over option in non-surgical arm
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olof Wolf, Associate Professor, MD, Principal investigator, Uppsala University Hospital and Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981065
- Sponsor's protocol ID
- 2025-01097-01
- Other IDs
- 2025
- Acronym
- ScanDiLaC
- Status last verified
- Dec 2025
- First submitted
- 12 May 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 42288927
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Scandinavian Displaced Lateral Clavicle Trial (ScanDiLaC) - A Multicentre, Pragmatic, 12-Month, Non-inferiority, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06981065
- Acronym / sponsor ID
- ScanDiLaC / 2025-01097-01
- Conditions
- Clavicle Fracture
- Keywords
- Displaced lateral clavicle fracture, Non-surgical, Surgical, PROMs, Health economy, Non-inferior, Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallell with cross-over option in non-surgical arm
| Arm | Type | Receives |
|---|---|---|
| Non-surgical | Experimental | Procedure: Simple Sling and PhysiotherapyNon-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 |
| Surgical | Active comparator | Procedure: Surgical treatmentSurgical treatment with plate and screws |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Displaced extraarticular lateral clavicle fracture (type II or V according to the modified Neer classification)
Key exclusion criteria (8 listed)
- Pathological fracture
- Open fracture
- Neurovascular injury
- Same-time fracture in the upper extremity
- Polytrauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple Sling and PhysiotherapyNon-surgical treatment with a simple sling and physiotherapy according to standardized program. | Procedure or surgery | Non-surgical |
| Surgical treatmentSurgical treatment with plate and screws (lateral clavicle plate, clavicle plate or hook plate with/without coracoclavicular fixation). | Procedure or surgery | Surgical |
Primary outcome
Disabilites of the Arm, Shoulder and Hand (DASH)
Time frame: 1 year
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Derived from this study: PubMed 42288927Christersson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olof Wolf, Associate Professor, MD principal investigator
Uppsala University Hospital and Uppsala University
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple Sling and Physiotherapy and Surgical treatment in people with Clavicle Fracture, run by Uppsala University at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Sweden, Denmark, Finland, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pontus Christersson, MD, PhD Student (+46-18-6110000, pontus.christersson@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilites of the Arm, Shoulder and Hand (DASH) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06981065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.