The Treatment of Clavicular Fractures

This study is not yet open for participant recruitment.

Verified by University Hospital, Ghent, April 2009

First Received: March 14, 2008 Last Updated: April 9, 2009 History of Changes

Sponsors and Collaborators:	University Hospital, Ghent Bart Berghs, MD - AZ Sint-Jan Brugge
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00642265

Purpose

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.

Condition	Intervention
Displaced, Midshaft Clavicular Fractures	Procedure: osteosynthesis Other: sling

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Union [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Functionality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Time to heal [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Cost [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Relation with medication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Relation with smoking [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Relation with job [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental operative treatment	Procedure: osteosynthesis operative treatment
2: Active Comparator conservative treatment	Other: sling conservative treatment

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642265

Contacts

Contact: Pieter-Jan Vandekerckhove, MD

+32 51 425185

Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000
AZ Sint Jan-Brugge
Brugge, Belgium, 8000
Sint-Andries Ziekenhuis
Tielt, Belgium, 8700
Jan Palfijnziekenhuis
Ghent, Belgium, 9000
Stedelijk Ziekenhuis Aalst
Aalst, Belgium, 9300
Stedelijk Ziekenhuis Roeselare
Roeselare, Belgium, 8800

Sponsors and Collaborators

University Hospital, Ghent

Bart Berghs, MD - AZ Sint-Jan Brugge

Investigators

Principal Investigator:	Lieven De Wilde, MD, PhD	University Hospital, Ghent
Principal Investigator:	Bart Berghs, MD	AZ Sint-Jan Brugge
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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital Ghent ( Lieven De Wilde, MD, PhD )
Study ID Numbers:	2007/573
Study First Received:	March 14, 2008
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00642265 History of Changes
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009