NCT01647178

Brief Summary

The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

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, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

1.6 years

First QC Date

July 17, 2012

Last Update Submit

August 31, 2015

Conditions

Post Cardiac SurgerySternal Closure

Outcome Measures

Primary Outcomes (2)

  • Respiratory function

    Pre-op, 2 and 4 days Post-op

  • Pain Score

    Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking

    2, 4, 14, 30 and 90 days post op

Study Arms (2)

Manual closure

ACTIVE COMPARATOR

Patients are closed with a manual, straight wire, conventional closure technique

Procedure: Conventional closure

TORQ closure

ACTIVE COMPARATOR

Patients are undergo a TORQ assisted sternal closure

Procedure: TORQ assisted sternal closure

Interventions

TORQ assisted sternal closurePROCEDURE
Also known as: TORQ (Manufacturer: Kardium, Richmond, Canada)
TORQ closure
Conventional closurePROCEDURE
Also known as: Straight wire closure
Manual closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referred for elective cardiac surgery at St Paul's Hospital
  • Expected to live greater than 12 months
  • Capable of giving written informed consent
  • Willing to participate in follow-up
  • Greater than 18 years of age, and of legal age of consent in host country

You may not qualify if:

  • Patient has had previous median sternotomy, requiring redo sternotomy
  • Surgeon has, prior to enrollment, elected to use alternative closure technique to the interrupted single wire circlage technique (e.g. Figure of 8 technique)
  • Surgeon has elected, prior to enrollment. to treat with the TORQ as a prophylactic measure (e.g. in high risk cases where use of the TORQ has been shown to be effective in preventing dehiscence)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Study Officials

  • James Abel, MD

    St. Paul's Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 23, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

CA(1)