TORQ Clinical Study (TORQClin)

Kardium

Status: Completed

Conditions: Post Cardiac Surgery; Sternal Closure

Treatments: Procedure: TORQ assisted sternal closure; Procedure: Conventional closure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01647178

H11-00310

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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92 participants in 2 patient groups

Manual closure

Active Comparator group

Description:

Patients are closed with a manual, straight wire, conventional closure technique

Treatment:

Procedure: Conventional closure

TORQ closure

Active Comparator group

Description:

Patients are undergo a TORQ assisted sternal closure

Treatment:

Procedure: TORQ assisted sternal closure