Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
|Clavicle Fracture Fractures||Procedure: Non-operative Treatment Procedure: Operative Treatment|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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|
- 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 ]
- 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 ]
|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)|
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872105
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5C 1R6|
|Principal Investigator:||Jeremy A Hall, MD, FRCS(C)||St. Michael's Hospital, Toronto|