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

Unity Health Toronto

Status

Completed

Conditions

Fractures

Clavicle Fracture

Treatments

Procedure: Operative Treatment

Procedure: Non-operative Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT00872105

Distal Clavicle Study

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

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.)