The Scandinavian Displaced Lateral Clavicle Trial

NCT ID: NCT06981065

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-17

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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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

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Clavicle Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallell with cross-over option in non-surgical arm
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-surgical

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

Group Type EXPERIMENTAL

Simple Sling and Physiotherapy

Intervention Type PROCEDURE

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

Surgical

Surgical treatment with plate and screws

Group Type ACTIVE_COMPARATOR

Surgical treatment

Intervention Type PROCEDURE

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

Interventions

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Simple Sling and Physiotherapy

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

Intervention Type PROCEDURE

Surgical treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olof Wolf, Associate Professor, MD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital and Uppsala University

Locations

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Odense University Hospital

Odense, , Denmark

Site Status NOT_YET_RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status NOT_YET_RECRUITING

Østfold Hospital Trust

Fredrikstad, , Norway

Site Status NOT_YET_RECRUITING

Kalmar Regional Hospital

Kalmar, , Sweden

Site Status RECRUITING

Linköping University Hospital

Linköping, , Sweden

Site Status RECRUITING

Skane University Hospital

Malmo, , Sweden

Site Status RECRUITING

Örebro University Hospital

Örebro, , Sweden

Site Status RECRUITING

Danderyd Hospital

Stockholm, , Sweden

Site Status RECRUITING

Stockholm South Hospital

Stockholm, , Sweden

Site Status RECRUITING

Norrlands University Hospital

Umeå, , Sweden

Site Status RECRUITING

Uppsala University Hopsital

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Denmark Finland Norway Sweden

Central Contacts

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Pontus Christersson, MD, PhD Student

Role: CONTACT

+46-18-6110000

Facility Contacts

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Bjarke Viberg

Role: primary

Antti Launonen

Role: primary

Frede Frihagen

Role: primary

Mats Ranbebo

Role: primary

+46103580000

Johan Scheer

Role: primary

+46-10-1030000

Jonas Nordin

Role: primary

+46-40-331000

Per Fischer

Role: primary

+46-19-6021000

Viktor Mili-Schmidt

Role: primary

+46-8-12355000

Johanna Rundgren

Role: primary

+46812361000

Jonas Sundkvist

Role: primary

+46-90-7850000

Pontus Christersson

Role: primary

+46-18-6110000

Other Identifiers

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2025-01097-01

Identifier Type: -

Identifier Source: org_study_id

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