Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
NCT ID: NCT00872105
Last Updated: 2019-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2009-03-31
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-operative treatment
The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture.
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.
Operative treatment
The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws.
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)
Interventions
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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.
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 Criteria
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Inclusion Criteria
* 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
* 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.)
16 Years
60 Years
ALL
No
Sponsors
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Fraser Health
OTHER
University of British Columbia
OTHER
London Health Sciences Centre
OTHER
University of Calgary
OTHER
Nova Scotia Health Authority
OTHER
Winnipeg Regional Health Authority
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
The Ottawa Hospital
OTHER
Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Jeremy A Hall, MD, FRCS(C)
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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Distal Clavicle Study
Identifier Type: -
Identifier Source: org_study_id
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