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TORQ Clinical Study (TORQClin)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Kardium Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
St. Paul's Hospital, Canada
Information provided by (Responsible Party):
Kardium Inc.
ClinicalTrials.gov Identifier:
NCT01647178
First received: July 17, 2012
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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 Intervention
Post Cardiac Surgery
Sternal Closure
Procedure: TORQ assisted sternal closure
Procedure: Conventional closure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
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.

Further study details as provided by Kardium Inc.:

Primary Outcome Measures:
  • Respiratory function [ Time Frame: Pre-op, 2 and 4 days Post-op ] [ Designated as safety issue: No ]
  • Pain Score [ Time Frame: 2, 4, 14, 30 and 90 days post op ] [ Designated as safety issue: No ]
    Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking


Estimated Enrollment: 96
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647178

Contacts
Contact: Naghmeh Esmaeili (604) 806-9148

Locations
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Naghmeh Esmaeili         
Sponsors and Collaborators
Kardium Inc.
St. Paul's Hospital, Canada
Investigators
Principal Investigator: James Abel, MD St. Paul's Hospital, Canada
  More Information

No publications provided

Responsible Party: Kardium Inc.
ClinicalTrials.gov Identifier: NCT01647178     History of Changes
Other Study ID Numbers: H11-00310
Study First Received: July 17, 2012
Last Updated: August 1, 2012
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on November 25, 2014