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

This study is currently recruiting participants.
Verified March 2014 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
Jeremy Hall, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00872105
First received: March 30, 2009
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Clavicle Fracture
Fractures
Procedure: Non-operative Treatment
Procedure: Operative Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 89
Study Start Date: March 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872105

Contacts
Contact: Milena R Vicente, RN 416-864-6060 ext 2608 vicentem@smh.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5C 1R6
Contact: Milena R Vicente, RN       vicentem@smh.ca   
Principal Investigator: Jeremy A Hall, MD, FRCS(C)         
Sub-Investigator: Michael D McKee, MD, FRCS(C)         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Jeremy A Hall, MD, FRCS(C) St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: Jeremy Hall, MD, FRCS(C), St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00872105     History of Changes
Other Study ID Numbers: Distal Clavicle Study
Study First Received: March 30, 2009
Last Updated: March 19, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
clavicle
fractures
distal

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014