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NCT Number: NCT06981065

The Scandinavian Displaced Lateral Clavicle 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.

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Key information

Conditions

Clavicle Fracture

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, Odense, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simple Sling and Physiotherapy

Procedure

Non-surgical treatment with a simple sling and physiotherapy according to standardized program.

surgical treatment

Procedure

Surgical treatment with plate and screws (lateral clavicle plate, clavicle plate or hook plate with/without coracoclavicular fixation).

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Pre-injury, 6 weeks, 3 months, 6 months, 2 years, 5 years

    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.

  2. Nottingham Clavicle Score (NCS)

    Time frame: 6 weeks, 3 months, 6 months, 1, 2, 5 years

    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).

  3. University of California, Los Angeles (UCLA) Activity scale

    Time frame: Pre-injury, 6 weeks, 3 months, 6 months, 1 years

    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.

  4. EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire

    Time frame: Pre-injury, 6 weeks, 3 months, 6 months, 1, 2, 5 years

    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.

  5. Visual Analog Scale (VAS) for pain

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2, 5 years

    Pain measure by visual analog scale in 11 levels. Minimum 0 and maximum 10. Higher figure indicates more pain. 10 is maximum pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Pontus Christersson, MD, PhD Student

CONTACT

[email protected]

+46-18-6110000

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

The Scandinavian Displaced Lateral Clavicle Trial (ScanDiLaC) - A Multicentre, Pragmatic, 12-Month, Non-inferiority, Randomized Controlled Trial

Acronym: ScanDiLaC

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 20, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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