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

Not Applicable
Completed
Conditions
Clavicle Fracture
Fractures
Registration Number
NCT00872105
Lead Sponsor
Unity Health Toronto
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
59
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.)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (1)

St. Michael's Hospital

🇨🇦

Toronto, Ontario, Canada

St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada

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