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

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

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.

Study Overview

• Status: Completed
• Conditions: Clavicle Fracture; Fractures
• Intervention / Treatment: Procedure: Non-operative Treatment; Procedure: Operative Treatment

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 1R6
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Non-operative treatment; The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture.	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.
Active Comparator: Operative treatment; The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws.	Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: University of British Columbia; McGill University Health Centre/Research Institute of the McGill University Health Centre; The Ottawa Hospital; University of Calgary; Nova Scotia Health Authority; London Health Sciences Centre; Fraser Health; Winnipeg Regional Health Authority
• Investigators: Principal Investigator: Jeremy A Hall, MD, FRCS(C), Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: March 30, 2009
• First Submitted That Met QC Criteria: March 30, 2009
• First Posted (Estimate): March 31, 2009

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: fractures; clavicle; distal
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: Distal Clavicle Study