TORQ Clinical Study

Not Applicable

Completed

• Conditions: Post Cardiac Surgery; Sternal Closure
• Interventions: Procedure: Conventional closure; Procedure: TORQ assisted sternal closure

• Registration Number: NCT01647178
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-23
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Manual closure	Conventional closure	Patients are closed with a manual, straight wire, conventional closure technique
TORQ closure	TORQ assisted sternal closure	Patients are undergo a TORQ assisted sternal closure

Primary Outcome Measures

Name	Time	Method
Respiratory function	Pre-op, 2 and 4 days Post-op
Pain Score	2, 4, 14, 30 and 90 days post op	Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada