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

Sponsor

Unity Health Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT00872105

Collaborator

Fraser Health (Other), University of British Columbia (Other), London Health Sciences Centre (Other), University of Calgary (Other), Nova Scotia Health Authority (Other), Winnipeg Regional Health Authority (Other), McGill University Health Centre/Research Institute of the McGill University Health Centre (Other), The Ottawa Hospital (Other)

Enrollment

Location

Arms

126

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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	Phase
Clavicle Fracture Fractures	Procedure: Non-operative Treatment Procedure: Operative Treatment	N/A

Study Design

Study Type:

Interventional

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 :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Sep 1, 2019

Arms and Interventions

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)

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)

Outcome Measures

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. [2 years]

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). [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada	M5C 1R6

Sponsors and Collaborators

Unity Health 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 Centre/Research Institute of the McGill University Health Centre
The Ottawa Hospital

Investigators

Principal Investigator: Jeremy A Hall, MD, FRCS(C), Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Unity Health Toronto

ClinicalTrials.gov Identifier:

NCT00872105

Other Study ID Numbers:

Distal Clavicle Study

First Posted:

Mar 31, 2009

Last Update Posted:

Nov 27, 2019

Last Verified:

Nov 1, 2019

Keywords provided by Unity Health Toronto

clavicle

fractures

distal

Additional relevant MeSH terms:

Fractures, Bone

Study Results

No Results Posted as of Nov 27, 2019