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The Treatment of Clavicular Fractures

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ClinicalTrials.gov Identifier: NCT00642265
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : March 25, 2008
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Displaced, Midshaft Clavicular Fractures Procedure: osteosynthesis Other: sling

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : April 2008
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
operative treatment
Procedure: osteosynthesis
operative treatment
Active Comparator: 2
conservative treatment
Other: sling
conservative treatment


Outcome Measures

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

Secondary Outcome Measures :
  1. Complications [ Time Frame: 1 year ]
  2. Time to heal [ Time Frame: 1 year ]
  3. Cost [ Time Frame: 1 year ]
  4. Relation with medication [ Time Frame: 1 year ]
  5. Relation with smoking [ Time Frame: 1 year ]
  6. Relation with job [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: March 25, 2008    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries