Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

Fractures Clinical Trial

Official title:

A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872105
• Other study ID #: Distal Clavicle Study
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: September 2019

Study information

• Verified date: November 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures
• Fractures, Bone

Intervention

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.
• 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)

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (9)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Fraser Health, London Health Sciences Centre, McGill University Health Centre/Research Institute of the McGill University Health Centre, Nova Scotia Health Authority, The Ottawa Hospital, University of British Columbia, University of Calgary, Winnipeg Regional Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years
Secondary	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).		2 years