NCT03289104

Brief Summary

The objective of this study is to determine whether sternal reconstruction using the ZIPFIX system compared to standard wire cerclage could improve bone healing, patient function, and decreased postoperative pain.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

January 31, 2017

Last Update Submit

December 13, 2018

Conditions

Sternal InjuryCardiac SurgeryHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • Sternal bone healing

    Assessment of how the sternum is healing, assessed via a CT scan and classified using a 6-point scale.

    3 months after surgery

Secondary Outcomes (5)

  • Post-operative pain

    Within 1 week of surgery

  • Use of narcotics

    In the first 6 months after surgery

  • Sternal instability

    In the first 6 months after surgery

  • Sternal wound infection

    In the first 6 months after surgery

  • Cost

    In the first 6 months after surgery.

Study Arms (2)

Steel Wires

ACTIVE COMPARATOR

In this arm, patients will have their sternum closed with steel wires.

Device: Steel Wires

ZipFix Sternal Closure System (Plastic Cables)

EXPERIMENTAL

In this arm, patients will have their sternum closed with the ZipFix system.

Device: ZipFix Sternal Closure System

Interventions

Steel WiresDEVICE

Control: Steel wires (device) are selected for sternal closure after surgery. Currently, most patients who have a sternotomy during cardiac surgery have their sternum closed with steel wires.

Steel Wires
ZipFix Sternal Closure SystemDEVICE

Treatment: ZipFix system (device) are selected for sternal closure after surgery. These plastic cables can also be used to close the sternum during bypass surgery.

ZipFix Sternal Closure System (Plastic Cables)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient age ≥ 18 years
  • Scheduled cardiac surgery including coronary artery bypass grafting, aortic valve replacement, mitral valve replacement/repair, or ascending aorta replacement.
  • Patient undergoing elective or urgent surgery
  • Ability to understand study procedures and to comply with them for the entire length of the study.

You may not qualify if:

  • Patients undergoing emergent cardiac surgery
  • Severe congestive heart failure (NYHA class III or IV) at enrollment
  • Prior cardiac surgery
  • Patients undergoing ventricular assist device insertion or heart transplantation
  • Patients with a known metal allergy or allergy to ZIPFIX implant
  • Patients who refuses consent
  • Patients who are unable to follow post-operative instructions
  • Prior history of significant bleeding that might be expected to recur with cardiac surgery
  • Dementia with a mini mental status examination (MMSE) score of \< 20
  • Extra cardiac illness that is expected to limit survival to less than 5 years
  • Suspected pregnancy. A pregnancy test (urine or serum) will be administered to all women not clearly menopausal
  • Concurrent enrollment in another clinical trial
  • Geographic inaccessibility for follow-up visits required by the protocol
  • Prisoners or institutionalized individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiac Surgery

Ottawa, Ontario, K1Y4W7, Canada

Location

Related Publications (10)

  • Karamlou T, Jacobs ML, Pasquali S, He X, Hill K, O'Brien S, McMullan DM, Jacobs JP. Surgeon and center volume influence on outcomes after arterial switch operation: analysis of the STS Congenital Heart Surgery Database. Ann Thorac Surg. 2014 Sep;98(3):904-11. doi: 10.1016/j.athoracsur.2014.04.093. Epub 2014 Jul 25.

    PMID: 25069686BACKGROUND

  • Kozower BD, Sheng S, O'Brien SM, Liptay MJ, Lau CL, Jones DR, Shahian DM, Wright CD. STS database risk models: predictors of mortality and major morbidity for lung cancer resection. Ann Thorac Surg. 2010 Sep;90(3):875-81; discussion 881-3. doi: 10.1016/j.athoracsur.2010.03.115.

    PMID: 20732512BACKGROUND

  • Raman J, Song DH, Bolotin G, Jeevanandam V. Sternal closure with titanium plate fixation--a paradigm shift in preventing mediastinitis. Interact Cardiovasc Thorac Surg. 2006 Aug;5(4):336-9. doi: 10.1510/icvts.2005.121863. Epub 2006 Apr 25.

    PMID: 17670585BACKGROUND

  • Pai S, Gunja NJ, Dupak EL, McMahon NL, Roth TP, Lalikos JF, Dunn RM, Francalancia N, Pins GD, Billiar KL. In vitro comparison of wire and plate fixation for midline sternotomies. Ann Thorac Surg. 2005 Sep;80(3):962-8. doi: 10.1016/j.athoracsur.2005.03.089.

    PMID: 16122464BACKGROUND

  • Losanoff JE, Basson MD, Gruber SA, Huff H, Hsieh FH. Single wire versus double wire loops for median sternotomy closure: experimental biomechanical study using a human cadaveric model. Ann Thorac Surg. 2007 Oct;84(4):1288-93. doi: 10.1016/j.athoracsur.2007.05.023.

    PMID: 17888985BACKGROUND

  • Losanoff JE, Collier AD, Wagner-Mann CC, Richman BW, Huff H, Hsieh Fh, Diaz-Arias A, Jones JW. Biomechanical comparison of median sternotomy closures. Ann Thorac Surg. 2004 Jan;77(1):203-9. doi: 10.1016/s0003-4975(03)01468-1.

    PMID: 14726062BACKGROUND

  • Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72. doi: 10.1016/j.ejcts.2004.04.038.

    PMID: 15296898BACKGROUND

  • Grapow MT, Melly LF, Eckstein FS, Reuthebuch OT. A new cable-tie based sternal closure system: description of the device, technique of implantation and first clinical evaluation. J Cardiothorac Surg. 2012 Jun 25;7:59. doi: 10.1186/1749-8090-7-59.

    PMID: 22731778BACKGROUND

  • Melly L, Gahl B, Meinke R, Rueter F, Matt P, Reuthebuch O, Eckstein FS, Grapow MT. A new cable-tie-based sternal closure device: infectious considerations. Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):219-23; discussion 223-4. doi: 10.1093/icvts/ivt183. Epub 2013 Apr 26.

    PMID: 23624983BACKGROUND

  • Stelly MM, Rodning CB, Stelly TC. Reduction in deep sternal wound infection with use of a peristernal cable-tie closure system: a retrospective case series. J Cardiothorac Surg. 2015 Nov 14;10:166. doi: 10.1186/s13019-015-0378-7.

    PMID: 26577944BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Marc Ruel, MD, MPH

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Cardiac Surgeon

Study Record Dates

First Submitted

January 31, 2017

First Posted

September 20, 2017

Study Start

September 1, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

December 17, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)