TORQ Clinical Study (TORQClin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01647178
Recruitment Status : Completed
First Posted : July 23, 2012
Last Update Posted : September 1, 2015
St. Paul's Hospital, Canada
Information provided by (Responsible Party):
Kardium Inc.

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.

Condition or disease Intervention/treatment Phase
Post Cardiac Surgery Sternal Closure Procedure: TORQ assisted sternal closure Procedure: Conventional closure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Influence of the TORQ Sternal Closure Assistance Device on Post-Operative Pain, Pulmonary Function and Quality of Life Compared to Traditional Manual Wire Closure: A Randomized Controlled Trial.
Study Start Date : March 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Active Comparator: Manual closure
Patients are closed with a manual, straight wire, conventional closure technique
Procedure: Conventional closure
Other Name: Straight wire closure
Active Comparator: TORQ closure
Patients are undergo a TORQ assisted sternal closure
Procedure: TORQ assisted sternal closure
Other Name: TORQ (Manufacturer: Kardium, Richmond, Canada)

Primary Outcome Measures :
  1. Respiratory function [ Time Frame: Pre-op, 2 and 4 days Post-op ]
  2. Pain Score [ Time Frame: 2, 4, 14, 30 and 90 days post op ]
    Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01647178

Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
Kardium Inc.
St. Paul's Hospital, Canada
Principal Investigator: James Abel, MD St. Paul's Hospital, Canada

Responsible Party: Kardium Inc. Identifier: NCT01647178     History of Changes
Other Study ID Numbers: H11-00310
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015