Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
Primary Purpose
Clavicle Fracture, Fractures
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Non-operative Treatment
Operative Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Clavicle Fracture focused on measuring clavicle, fractures, distal
Eligibility 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.)
Sites / Locations
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Non-operative treatment
Operative treatment
Arm Description
The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture.
The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws.
Outcomes
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.
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).
Full Information
NCT ID
NCT00872105
First Posted
March 30, 2009
Last Updated
November 25, 2019
Sponsor
Unity Health 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 Centre/Research Institute of the McGill University Health Centre, The Ottawa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00872105
Brief Title
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
Official Title
A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health 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 Centre/Research Institute of the McGill University Health Centre, The Ottawa Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clavicle Fracture, Fractures
Keywords
clavicle, fractures, distal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-operative treatment
Arm Type
Other
Arm Description
The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture.
Arm Title
Operative treatment
Arm Type
Active Comparator
Arm Description
The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws.
Intervention Type
Procedure
Intervention Name(s)
Non-operative Treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Operative Treatment
Intervention Description
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)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy A Hall, MD, FRCS(C)
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
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