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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
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Displaced, Midshaft Clavicular Fractures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 14, 2008
Last Updated
January 3, 2023
Sponsor
University Hospital, Ghent
Collaborators
AZ Sint-Jan AV
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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

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The Treatment of Clavicular Fractures

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