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Studies

Interventional Recruiting

NCT06981065 on ClinicalTrials.gov

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

  • Sponsor: Uppsala University
  • Enrollment: 96 (Estimated)
  • Study start: 2025-09-17 (Actual)
  • Primary completion: 2028-12-31 (Estimated)
  • Study completion: 2029-12-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Parallell with cross-over option in non-surgical arm
  • Masking: None
  • PrimaryPurpose: 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.

Conditions

  • Clavicle Fracture

Intervention / Treatment

  • Procedure: Simple Sling and Physiotherapy
  • Procedure: Surgical treatment

Primary Outcome Measures

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

Countries

Denmark, Finland, Norway, Sweden

Locations and Investigators

  • Odense University Hospital, Odense, Denmark (Not yet recruiting)
    • Bjarke Viberg
  • Tampere University Hospital, Tampere, Finland (Not yet recruiting)
    • Antti Launonen
  • Østfold Hospital Trust, Fredrikstad, Norway (Not yet recruiting)
    • Frede Frihagen
  • Kalmar Regional Hospital, Kalmar, Sweden (Recruiting)
    • Mats Ranbebo
  • Linköping University Hospital, Linköping, Sweden (Recruiting)
    • Johan Scheer
  • Skane University Hospital, Malmo, Sweden (Recruiting)
    • Jonas Nordin
  • Örebro University Hospital, Örebro, Sweden (Recruiting)
    • Per Fischer
  • Danderyd Hospital, Stockholm, Sweden (Recruiting)
    • Viktor Mili-Schmidt
  • Stockholm South Hospital, Stockholm, Sweden (Recruiting)
    • Johanna Rundgren
  • Norrlands University Hospital, UmeÃ¥, Sweden (Recruiting)
    • Jonas Sundkvist
  • Uppsala University Hopsital, Uppsala, Sweden (Recruiting)
    • Pontus Christersson

Study Officials