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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Phase
Clavicle Fracture; Fractures	Procedure: Non-operative Treatment; Procedure: Operative Treatment	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years to 60 Years (Child, Adult)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Investigators

Principal Investigator:	Jeremy A Hall, MD, FRCS(C)	St. Michael's Hospital, Toronto

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
Last Update Posted:	November 27, 2017
Last Verified:	November 2017

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

clavicle; fractures; distal

Additional relevant MeSH terms:

Fractures, Bone; Wounds and Injuries