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The Scandinavian Displaced Lateral Clavicle Trial

ConditionClavicle Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUppsala University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Pathological fracture

Open fracture

Neurovascular injury

Same-time fracture in the upper extremity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Simple Sling and Physiotherapy

    Procedure/Surgery

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

  • Surgical treatment

    Procedure/Surgery

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

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Non-surgicalExperimental treatment 1 intervention
Group B: SurgicalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

1

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.

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

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).

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

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.

Time frame
Pre-injury, 6 weeks, 3 months, 6 months, 1 years
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uppsala University

Lead sponsor

Source ClinicalTrials.gov
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