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The Treatment of Clavicular Fractures

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00642265
First Posted: March 25, 2008
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AZ Sint-Jan AV
Information provided by (Responsible Party):
University Hospital, Ghent
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Union [ Time Frame: 1 year ]
  • Functionality [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Complications [ Time Frame: 1 year ]
  • Time to heal [ Time Frame: 1 year ]
  • Cost [ Time Frame: 1 year ]
  • Relation with medication [ Time Frame: 1 year ]
  • Relation with smoking [ Time Frame: 1 year ]
  • Relation with job [ Time Frame: 1 year ]

Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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         
Jan Palfijnziekenhuis Recruiting
Ghent, Belgium, 9000
Principal Investigator: G. Vandendriessche, MD         
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Lieven De Wilde, MD, PhD         
Sub-Investigator: Alexander Schepens, 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
AZ Sint-Jan AV
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00642265     History of Changes
Other Study ID Numbers: 2007/573
First Submitted: March 14, 2008
First Posted: March 25, 2008
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries