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

NCT00872105 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2019-11-27

No results posted yet for this study

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.

Conditions

  • Clavicle Fracture
  • Fractures

Interventions

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.

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)

Sponsors & Collaborators

  • Fraser Health

    collaborator OTHER

  • University of British Columbia

    collaborator OTHER

  • London Health Sciences Centre

    collaborator OTHER

  • University of Calgary

    collaborator OTHER

  • Nova Scotia Health Authority

    collaborator OTHER

  • Winnipeg Regional Health Authority

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • The Ottawa Hospital

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Jeremy A Hall, MD, FRCS(C) · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2018-12-31
Completion
2019-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00872105 on ClinicalTrials.gov