The Treatment of Clavicular Fractures
Primary Purpose
Displaced, Midshaft Clavicular Fractures
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
osteosynthesis
sling
Sponsored by
About this trial
This is an interventional treatment trial for Displaced, Midshaft Clavicular Fractures
Eligibility Criteria
Inclusion Criteria:
- 18 to 65 year
- 100% displaced midshaft clavicular fracture
shortening
- male: 18mm
- female: 14mm
Exclusion Criteria:
- pregnancy
- pathological fracture
- open fracture
- history of frozen shoulder
- ipsilateral fracture of shoulder or scapula
- neurovascular injury
- contraindication to anaesthesia
Sites / Locations
- Stedelijk Ziekenhuis Aalst
- AZ Sint Jan-Brugge
- Jan Palfijnziekenhuis
- University Hospital Ghent
- Stedelijk Ziekenhuis Roeselare
- Sint-Andries Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
operative treatment
conservative treatment
Outcomes
Primary Outcome Measures
Union
Functionality
Secondary Outcome Measures
Complications
Time to heal
Cost
Relation with medication
Relation with smoking
Relation with job
Full Information
NCT ID
NCT00642265
First Posted
March 14, 2008
Last Updated
January 3, 2023
Sponsor
University Hospital, Ghent
Collaborators
AZ Sint-Jan AV
1. Study Identification
Unique Protocol Identification Number
NCT00642265
Brief Title
The Treatment of Clavicular Fractures
Official Title
The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 2008 (Actual)
Primary Completion Date
May 27, 2009 (Actual)
Study Completion Date
May 27, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
AZ Sint-Jan AV
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Displaced, Midshaft Clavicular Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
operative treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
conservative treatment
Intervention Type
Procedure
Intervention Name(s)
osteosynthesis
Intervention Description
operative treatment
Intervention Type
Other
Intervention Name(s)
sling
Intervention Description
conservative treatment
Primary Outcome Measure Information:
Title
Union
Time Frame
1 year
Title
Functionality
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complications
Time Frame
1 year
Title
Time to heal
Time Frame
1 year
Title
Cost
Time Frame
1 year
Title
Relation with medication
Time Frame
1 year
Title
Relation with smoking
Time Frame
1 year
Title
Relation with job
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 65 year
100% displaced midshaft clavicular fracture
shortening
male: 18mm
female: 14mm
Exclusion Criteria:
pregnancy
pathological fracture
open fracture
history of frozen shoulder
ipsilateral fracture of shoulder or scapula
neurovascular injury
contraindication to anaesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieven De Wilde, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bart Berghs, MD
Organizational Affiliation
AZ Sint-Jan AV
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pieter-Jan Vandekerckhove, MD
Organizational Affiliation
Sint-Andriesziekenhuis Tielt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Van Den Daele, MD
Organizational Affiliation
Stedelijk Ziekenhuis Roeselare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Vanonverschelde, MD
Organizational Affiliation
Stedelijk Ziekenhuis Aalst
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
G. Vandendriessche, MD
Organizational Affiliation
Jan Palfijnziekenhuis Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stedelijk Ziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
AZ Sint Jan-Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Jan Palfijnziekenhuis
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Stedelijk Ziekenhuis Roeselare
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Sint-Andries Ziekenhuis
City
Tielt
ZIP/Postal Code
8700
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Related Info
Learn more about this trial
The Treatment of Clavicular Fractures
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