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

Not Applicable

Completed

• Conditions: Clavicle Fracture; Fractures
• Interventions: Procedure: Non-operative Treatment; Procedure: Operative Treatment

• 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

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-30
• Study First Posted: 2009-03-31
• Primary Completion: 2018-12
• Study Completion: 2019-09
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-27

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

Arm && Interventions

Group	Intervention	Description
Non-operative treatment	Non-operative Treatment	The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture.
Operative treatment	Operative Treatment	The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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