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OpenTrials
Completed

NCT Number: NCT01647178

TORQ Clinical Study

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.

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Key information

Conditions

Post Cardiac Surgery Sternal Closure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TORQ assisted sternal closure

Procedure

Other names: TORQ (Manufacturer: Kardium, Richmond, Canada)

Conventional closure

Procedure

Other names: Straight wire closure

Primary outcomes

  1. Respiratory function

    Time frame: Pre-op, 2 and 4 days Post-op

  2. Pain Score

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

    Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking

Sponsors and collaborators

Lead sponsor

Kardium Inc.

Industry

Collaborators

  • St. Paul's Hospital, Canada

Registry information

Official study title

The Influence of the TORQ Sternal Closure Assistance Device on Post-Operative Pain, Pulmonary Function and Quality of Life Compared to Traditional Manual Wire Closure: A Randomized Controlled Trial.

Acronym: TORQClin

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 23, 2012
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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