The Treatment of Clavicular Fractures
The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study
1 other identifier
interventional
100
1 country
6
Brief Summary
Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks. Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2008
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2009
CompletedJanuary 4, 2023
January 1, 2023
1.2 years
March 14, 2008
January 3, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Union
1 year
Functionality
1 year
Secondary Outcomes (6)
Complications
1 year
Time to heal
1 year
Cost
1 year
Relation with medication
1 year
Relation with smoking
1 year
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALoperative treatment
2
ACTIVE COMPARATORconservative treatment
Interventions
Eligibility Criteria
You may qualify if:
- to 65 year
- % displaced midshaft clavicular fracture
- shortening
- male: 18mm
- female: 14mm
You may not qualify if:
- pregnancy
- pathological fracture
- open fracture
- history of frozen shoulder
- ipsilateral fracture of shoulder or scapula
- neurovascular injury
- contraindication to anaesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- AZ Sint-Jan AVcollaborator
Study Sites (6)
Stedelijk Ziekenhuis Aalst
Aalst, 9300, Belgium
AZ Sint Jan-Brugge
Bruges, 8000, Belgium
Jan Palfijnziekenhuis
Ghent, 9000, Belgium
University Hospital Ghent
Ghent, 9000, Belgium
Stedelijk Ziekenhuis Roeselare
Roeselare, 8800, Belgium
Sint-Andries Ziekenhuis
Tielt, 8700, Belgium
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lieven De Wilde, MD, PhD
University Hospital, Ghent
- PRINCIPAL INVESTIGATOR
Bart Berghs, MD
AZ Sint-Jan AV
- PRINCIPAL INVESTIGATOR
Pieter-Jan Vandekerckhove, MD
Sint-Andriesziekenhuis Tielt
- PRINCIPAL INVESTIGATOR
J. Van Den Daele, MD
Stedelijk Ziekenhuis Roeselare
- PRINCIPAL INVESTIGATOR
J. Vanonverschelde, MD
Stedelijk Ziekenhuis Aalst
- PRINCIPAL INVESTIGATOR
G. Vandendriessche, MD
Jan Palfijnziekenhuis Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2008
First Posted
March 25, 2008
Study Start
April 1, 2008
Primary Completion
May 27, 2009
Study Completion
May 27, 2009
Last Updated
January 4, 2023
Record last verified: 2023-01