Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
This study is currently recruiting participants.
Verified April 2013 by St. Michael's Hospital, Toronto
Sponsor:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Jeremy Hall, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00872105
First received: March 30, 2009
Last updated: April 30, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ] [ 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: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (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 |
| 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
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
Investigators
| Principal Investigator: | Jeremy A Hall, MD, FRCS(C) | St. Michael's Hospital, Toronto |
More Information
No publications provided
| Responsible Party: | Jeremy Hall, MD, FRCS(C), 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 30, 2013 |
| 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 May 16, 2013