TORQ Clinical Study

Kardium Inc.92 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Post Cardiac Surgery Sternal Closure

Interventions

TORQ assisted sternal closurePROCEDURE

Conventional closurePROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Respiratory function

Time frame: 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

Time frame: 2, 4, 14, 30 and 90 days post op

Data from ClinicalTrials.gov

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