The Treatment of Clavicular Fractures

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
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, see Learn About Clinical Studies.

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:
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 July 29, 2014