The Treatment of Clavicular Fractures | NCT00642265

Studies
The Treatment of Clavicular Fractures

NCT00642265

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Jan 4, 2023Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Displaced, Midshaft Clavicular Fractures

Interventions

osteosynthesis
sling

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008Actual

Primary Completion Date

May 27, 2009Actual

Completion Date

May 27, 2009Actual

First Submitted Date

Mar 14, 2008

First Submission Date that Met QC Criteria

Mar 24, 2008

First Posted Date

Mar 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2023

Last Update Posted Date

Jan 4, 2023Actual

Name	Class
AZ Sint-Jan AV	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	operative treatment	Procedure: osteosynthesis
2	Active Comparator	conservative treatment	Other: sling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
osteosynthesis	Procedure	operative treatment	1
sling

Measure	Description	Time Frame
Union		1 year
Functionality		1 year

Measure	Description	Time Frame
Complications		1 year
Time to heal		1 year
Cost

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stedelijk Ziekenhuis Aalst		Aalst		9300	Belgium
AZ Sint Jan-Brugge

Label	URL
Related Info	View source

Intervention Browse Module

MeSH Terms

ID	Term
D005593	Fracture Fixation, Internal
D053825	Suburethral Slings

Ancestor Terms

ID	Term
D005592	Fracture Fixation
D019637	Orthopedic Procedures
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided