TORQ Clinical Study (TORQClin)

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.

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.

Study Overview

• Status: Completed
• Conditions: Post Cardiac Surgery; Sternal Closure
• Intervention / Treatment: Procedure: Conventional closure; Procedure: TORQ assisted sternal closure

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kardium Inc.
• Collaborators: St. Paul's Hospital, Canada
• Investigators: Principal Investigator: James Abel, MD, St. Paul's Hospital, Canada

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimate): July 23, 2012

Study Record Updates

• Last Update Posted (Estimate): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: H11-00310