We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00872105
Recruitment Status : Active, not recruiting
First Posted : March 31, 2009
Last Update Posted : November 27, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Clavicle Fracture Fractures Procedure: Non-operative Treatment Procedure: Operative Treatment

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872105

Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 1R6
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Fraser Health
University of British Columbia
London Health Sciences Centre
University of Calgary
Nova Scotia Health Authority
Winnipeg Regional Health Authority
McGill University Health Center
The Ottawa Hospital
Principal Investigator: Jeremy A Hall, MD, FRCS(C) St. Michael's Hospital, Toronto
More Information

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00872105     History of Changes
Other Study ID Numbers: Distal Clavicle Study
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries