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The Treatment of Clavicular Fractures

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Bart Berghs, MD - AZ Sint-Jan Brugge, Belgium
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00642265
First received: March 14, 2008
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

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: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
operative treatment
 Procedure: osteosynthesis
operative treatment
Active Comparator: 2
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
Stedelijk Ziekenhuis Aalst Recruiting
Aalst, Belgium, 9300
Principal Investigator: J. Vanonverschelde, MD            
AZ Sint Jan-Brugge Recruiting
Brugge, Belgium, 8000
Principal Investigator: Bart Berghs, MD            
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Lieven De Wilde, MD, PhD            
Sub-Investigator: Alexander Schepens, MD            
Jan Palfijnziekenhuis Recruiting
Ghent, Belgium, 9000
Principal Investigator: G. Vandendriessche, MD            
Stedelijk Ziekenhuis Roeselare Recruiting
Roeselare, Belgium, 8800
Principal Investigator: J. Van Den Daele, MD            
Sint-Andries Ziekenhuis Recruiting
Tielt, Belgium, 8700
Principal Investigator: Pieter-Jan Vandekerckhove, MD            
Sponsors and Collaborators
University Hospital, Ghent
Bart Berghs, MD - AZ Sint-Jan Brugge, Belgium
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
ClinicalTrials.gov Identifier: NCT00642265     History of Changes
Other Study ID Numbers: 2007/573
Study First Received: March 14, 2008
Last Updated: January 31, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013