COR-KNOT Versus Manually Hand-tied Knots

Not Applicable

Completed

• Conditions: Suture Tying
• Interventions: Device: COR-KNOT; Procedure: Standard Suture Tying

• Registration Number: NCT02720913
• Lead Sponsor: The Cleveland Clinic

Brief Summary

The COR-KNOT technology (LSI SOLUTIONS, Victor, New York USA) was developed to replace suture tying with a faster procedure during surgery. While preclinical studies confirmed the speed of COR-KNOT use, no clinical studies have quantitatively compared the speed of suture fixation delivered by the COR-KNOT device with the speed of conventional hand-tied knots. COR-KNOT is expensive, costing 189 $ per application. Given this added expense, it is important to quantify the time-saved by application of this technology.

Detailed Description

The COR-KNOT device was developed to make suture fixation faster and save operative time. With a single squeeze of the lever, the device remotely and automatically secures sutures with a titanium fastener, while also simultaneously trimming excess suture tails. This device has been accepted by cardiac surgeons for the recognized benefits of time savings, simplicity, and reliability.

While the device presents ergonomic advantages during minimally invasive cardiac surgery, it enjoys widespread use in sternotomy-based, standard heart surgery. The relative cost of the device as a function of time saved has not been assessed. The purpose of this trial is to determine the relative time savings and cost of COR-KNOT compared to standard hand-tied knots in patients undergoing mitral/tricuspid ring annuloplasty repairs via traditional open heart surgery. Valve repair surgery is a common setting for COR-KNOT use and therefore serves as an appropriate procedure for evaluation of the technology.

The investigators propose a prospective, randomized trial in patients undergoing mitral or tricuspid ring annuloplasty repair to 1) Determine the time require per knot for COR-KNOT versus standard hand-tied knots and 2) Quantify the relative cost of COR-KNOT versus that of standard, hand-tied knots. Data from this study will enable the investigators to determine the cost-benefit of using COR-KNOT technology in cardiac surgery.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-28
• Primary Completion: 2017-01
• Study Completion: 2017-01-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Scheduled for Valvular ring annuloplasty for mitral and/or tricuspid valve repair
• Age > 18 years
• Able and willing to give informed consent

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COR-KNOT	COR-KNOT	The COR-KNOT device was developed to make suture fixation faster and save operative time. With a single squeeze of the lever, the device remotely and automatically secures sutures with a titanium fastener, while also simultaneously trimming excess suture tails.
Standard Suture Tying	Standard Suture Tying	Standard Suture Tying

Primary Outcome Measures

Name	Time	Method
Time (seconds) required to use COR-KNOT vs. Standard Suture Tying	60 seconds

Secondary Outcome Measures

Name	Time	Method
Cost (US Dollar) of using COR-KNOT vs. Standard Suture Tying	60 seconds	Assess cost using manufacturer price quotes (US$)