TORQ Clinical Study

Post Cardiac Surgery Clinical Trial

— TORQClin  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647178
• Other study ID #: H11-00310
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: August 31, 2015
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: August 2015
• Source: Kardium Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Cardiac Surgery
• Sternal Closure

Intervention

Procedure:
• TORQ assisted sternal closure

• Conventional closure

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Kardium Inc.	St. Paul's Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory function		Pre-op, 2 and 4 days Post-op	No
Primary	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	No