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

Unity Health Toronto1 site in 1 country59 target enrollmentMarch 2009

ConditionsClavicle Fracture Fractures

Overview

Phase: N/A
Intervention: Not specified
Conditions: Clavicle Fracture
Sponsor: Unity Health Toronto
Enrollment: 59
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

September 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Unity Health Toronto

Responsible Party

Sponsor

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.)

Outcomes

Primary Outcomes

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 Outcomes

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)