TORQ Clinical Study
Not Applicable
Completed
- Conditions
- Post Cardiac SurgerySternal 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
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
- 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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which sternal closure devices reduce postoperative pain in cardiac surgery patients?
How does the TORQ device compare to traditional manual wire closure in terms of pulmonary function recovery after median sternotomy?
Are there specific biomarkers that predict better outcomes with mechanical sternal closure assistance versus standard techniques?
What adverse events are associated with sternal closure devices like TORQ compared to conventional wire drivers in cardiac surgery?
What is the impact of TORQ on quality of life metrics in post-cardiac surgery patients compared to standard-of-care sternal closure methods?
Trial Locations
- Locations (1)
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital🇨🇦Vancouver, British Columbia, Canada