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Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
This study is ongoing, but not recruiting participants.
Sponsor:
St. Michael's Hospital, Toronto
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: October 24, 2016
Last verified: October 2016
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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:
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 ]
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 ]
| Enrollment: | 59 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (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) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00872105
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872105
Locations
| Canada, Ontario | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5C 1R6 | |
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: | October 24, 2016 |
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 July 28, 2017