Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
|ClinicalTrials.gov Identifier: NCT00872105|
Recruitment Status : Active, not recruiting
First Posted : March 31, 2009
Last Update Posted : December 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Clavicle Fracture Fractures||Procedure: Non-operative Treatment Procedure: Operative Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872105
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5C 1R6|
|Principal Investigator:||Jeremy A Hall, MD, FRCS(C)||St. Michael's Hospital, Toronto|