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
AZ Sint-Jan AV
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: March 14, 2008
Last updated: December 4, 2014
Last verified: December 2014

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 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:

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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00642265

Stedelijk Ziekenhuis Aalst
Aalst, Belgium, 9300
AZ Sint Jan-Brugge
Brugge, Belgium, 8000
Jan Palfijnziekenhuis
Ghent, Belgium, 9000
University Hospital Ghent
Ghent, Belgium, 9000
Stedelijk Ziekenhuis Roeselare
Roeselare, Belgium, 8800
Sint-Andries Ziekenhuis
Tielt, Belgium, 8700
Sponsors and Collaborators
University Hospital, Ghent
AZ Sint-Jan AV
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 Identifier: NCT00642265     History of Changes
Other Study ID Numbers: 2007/573 
Study First Received: March 14, 2008
Last Updated: December 4, 2014

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries processed this record on January 23, 2017