Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by St. Michael's Hospital, Toronto
Sponsor:
Collaborators:
Fraser Health
University of British Columbia
London Health Sciences Centre
University of Calgary
Nova Scotia Health Authority
Winnipeg Regional Health Authority
McGill University Health Center
The Ottawa Hospital
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00872105
First received: March 30, 2009
Last updated: April 18, 2016
Last verified: April 2016
History of Changes
  Purpose
This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.

Condition Intervention
Clavicle Fracture
Fractures
 Procedure: Non-operative Treatment
Procedure: Operative Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome measurement patients' functional shoulder scores as defined by Constant's Shoulder Score (i.e. pain, activities of daily living, range of motion and power). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Estimated Enrollment: 89
Study Start Date: March 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Non-operative treatment
The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture.
 Procedure: Non-operative Treatment
Standard protocol for conservative treatment will consist of the implementation of a sling, for clavicular support and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon.
Active Comparator: Operative treatment
The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws.
 Procedure: Operative Treatment

The operating surgeon will determine the positioning of the patient for surgery. ORIF of the distal clavicle fracture will be carried out as follows:

Anatomic reduction of the fracture Definitive fixation with a contoured clavicle plate and screws; a AO hook plate; a 3.5 LCDC, reconstruction, or compression plate is acceptable; a 1/3 tubular plate is not acceptable Use of bone graft is optional (iliac crest bone autograft)

  Eligibility
Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women aged 16 to 60 years of age
  • Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph
  • Fractures within 28 days post injury
  • Provision of informed consent

Exclusion Criteria:

  • Pathological fractures
  • Non-displaced (cortical contact) distal clavicle fractures
  • Open clavicle fractures
  • Presence of vascular injury
  • Fractures more than 28 days post-injury
  • Limited life expectancy due to significant medical co-morbidity
  • Medical contraindication to surgery
  • Inability to comply with rehabilitation or form completion
  • Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
  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: NCT00872105

Contacts
Contact: Milena R Vicente, RN 416-864-6060 ext 2608 vicentem@smh.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5C 1R6
Contact: Milena R Vicente, RN       vicentem@smh.ca   
Principal Investigator: Jeremy A Hall, MD, FRCS(C)         
Sub-Investigator: Michael D McKee, MD, FRCS(C)         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Fraser Health
University of British Columbia
London Health Sciences Centre
University of Calgary
Nova Scotia Health Authority
Winnipeg Regional Health Authority
McGill University Health Center
The Ottawa Hospital
Investigators
Principal Investigator: Jeremy A Hall, MD, FRCS(C) St. Michael's Hospital, Toronto
  More Information

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00872105     History of Changes
Other Study ID Numbers: Distal Clavicle Study 
Study First Received: March 30, 2009
Last Updated: April 18, 2016
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
clavicle
fractures
distal

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on September 29, 2016