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A multicentre multinational RCT to investigate whether non-surgical treatment is non-inferior to surgical treatment for displaced extraarticular lateral clavicle fractures in adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Surgical | Active Comparator | Surgical treatment with plate and screws |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simple Sling and Physiotherapy | Procedure | Non-surgical treatment with a simple sling and physiotherapy according to standardized program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
- Displaced extraarticular lateral clavicle fracture (type II or V according to the modified Neer classification)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pontus Christersson, MD, PhD Student | Contact | +46-18-6110000 | pontus.christersson@uu.se |
| Name | Affiliation | Role |
|---|---|---|
| Olof Wolf, Associate Professor, MD | Uppsala University Hospital and Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Not yet recruiting | Odense | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42288927 | Derived | 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. |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Parallell with cross-over option in non-surgical arm
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| Surgical treatment | Procedure | Surgical treatment with plate and screws (lateral clavicle plate, clavicle plate or hook plate with/without coracoclavicular fixation). |
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| 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). | 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. | 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. | 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. | Baseline, 6 weeks, 3 months, 6 months, 1, 2, 5 years |
| Tampere University Hospital | Not yet recruiting | Tampere | Finland |
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| Østfold Hospital Trust | Not yet recruiting | Fredrikstad | Norway |
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| Kalmar Regional Hospital | Recruiting | Kalmar | Sweden |
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| Linköping University Hospital | Recruiting | Linköping | Sweden |
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| Skane University Hospital | Recruiting | Malmö | Sweden |
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| Örebro University Hospital | Recruiting | Örebro | Sweden |
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| Danderyd Hospital | Recruiting | Stockholm | Sweden |
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| Stockholm South Hospital | Recruiting | Stockholm | Sweden |
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| Norrlands University Hospital | Recruiting | Umeå | Sweden |
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| Uppsala University Hopsital | Recruiting | Uppsala | Sweden |
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