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

Unity Health Toronto59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clavicle Fracture Fractures

Interventions

Non-operative TreatmentPROCEDURE

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.

Operative TreatmentPROCEDURE

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

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.)

Locations (1)

St. Michael's Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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