NCT00872105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

9.8 years

First QC Date

March 30, 2009

Last Update Submit

November 25, 2019

Conditions

Clavicle FractureFractures

Keywords

claviclefracturesdistal

Outcome Measures

Primary Outcomes (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.

    2 years

Secondary Outcomes (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).

    2 years

Study Arms (2)

Non-operative treatment

OTHER

The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture.

Procedure: Non-operative Treatment

Operative treatment

ACTIVE COMPARATOR

The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws.

Procedure: Operative Treatment

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.

Non-operative treatment
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)

Operative treatment

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Jeremy A Hall, MD, FRCS(C)

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2009

First Posted

March 31, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2018

Study Completion

September 1, 2019

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

CA(1)