NCT02686099

Brief Summary

The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system. The cerclage material serves to facilitate sternal approximation, and the plates and screws serve to provide rigid fixation and prevent sternal movement and separation. The combination of a cerclage material in combination with plate and screw fixation may also lead to increased stability compared to either method used as a standalone means of closure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 4, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

2.2 years

First QC Date

February 9, 2016

Last Update Submit

January 16, 2018

Conditions

Sternal Fracture

Keywords

Rigid FixationSternal PlatingSternal ClosureSternalock

Outcome Measures

Primary Outcomes (1)

  • Sternal Bone Healing

    Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively

    6 months

Secondary Outcomes (4)

  • Sternal Pain

    Baseline, postoperative day 3 to day 7, 1-month post-op, 3-month post-op and 6-month post-op

  • Analgesic usage

    Baseline, postoperative day 0 to day 7, 1-month post-op, 3-month post-op and 6-month post-op

  • Upper Extremities Functional Status

    Baseline, 1-month post-op, 3-month post-op and 6-month post-op

  • Return to Work

    Baseline, 1-month post-op, 3-month post-op and 6-month post-op

Study Arms (2)

SternaLock 360

EXPERIMENTAL

Sternal closure performed with SternaLock 360 as a primary closure system

Device: SternaLock 360

Wire Cerclage

ACTIVE COMPARATOR

Sternal closure performed with standard wire cerclage as a primary closure system

Device: Wire Cerclage

Interventions

SternaLock 360DEVICE

Sternal closure with SternaLock 360

SternaLock 360
Wire CerclageDEVICE

Sternal closure with standard wire cerclage

Wire Cerclage

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing a standard midline sternotomy as a result of a cardiac surgical procedure (i.e. coronary artery bypass graft (CABG) and/or valve replacement along with other cardiac surgical procedures)
  • Patients ≥ 30 years of age
  • Patients who sign the Informed Consent

You may not qualify if:

  • Patients with endstage renal failure who are on dialysis or post transplant patients
  • Patients taking chronic (\>30 days) pre-operative narcotics
  • Patients taking chronic (\>30 days) steroids, immunosuppressant (including biologic immunosuppressants such as Enbrel), or chemotherapeutics (e.g. methotrexate). Patients using a steroid inhaler for asthma should not be excluded.
  • Patients with confirmed HIV with a viral load of \>10,000 copies
  • Patients with an active infection that is currently being treated
  • Patients with history or confirmed metal allergy or foreign body sensitivity
  • Patients with a previous partial or full midline sternotomy
  • Patients with previous radiation treatment of the chest
  • Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure: i.e., patients with cardiac disease resulting in inability to carry on any physical activity without discomfort (CCS ; NYHA)
  • Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia (STS)
  • Patients unwilling or unable to return for follow-up
  • Patients requiring delayed sternotomy closure
  • Patients with transverse sternal fractures located beneath the cerclage band on the SternaLock 360 Device.
  • Patients presenting intra-operative conditions that in the opinion of the treating surgeon would require or preclude a specific method for sternal closure, or who are not able to be closed per the protocol.
  • Use of non resorbable (beeswax) bonewax along the sternotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groote Schuur Hospital

Cape Town, South Africa

Location

Related Publications (13)

  • Casha AR, Yang L, Kay PH, Saleh M, Cooper GJ. A biomechanical study of median sternotomy closure techniques. Eur J Cardiothorac Surg. 1999 Mar;15(3):365-9. doi: 10.1016/s1010-7940(99)00014-7.

    PMID: 10333037BACKGROUND

  • Cohen DJ, Griffin LV. A biomechanical comparison of three sternotomy closure techniques. Ann Thorac Surg. 2002 Feb;73(2):563-8. doi: 10.1016/s0003-4975(01)03389-6.

    PMID: 11845875BACKGROUND

  • Hirose H, Yamane K, Youdelman BA, Bogar L, Diehl JT. Rigid sternal fixation improves postoperative recovery. Open Cardiovasc Med J. 2011;5:148-52. doi: 10.2174/1874192401105010148. Epub 2011 Jul 4.

    PMID: 21760857BACKGROUND

  • Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.

    PMID: 17006079BACKGROUND

  • 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

  • Meyerson J, Thelin S, Gordh T, Karlsten R. The incidence of chronic post-sternotomy pain after cardiac surgery--a prospective study. Acta Anaesthesiol Scand. 2001 Sep;45(8):940-4. doi: 10.1034/j.1399-6576.2001.450804.x.

    PMID: 11576043BACKGROUND

  • Pai S, Gunja NJ, Dupak EL, McMahon NL, Coburn JC, Lalikos JF, Dunn RM, Francalancia N, Pins GD, Billiar KL. A mechanical study of rigid plate configurations for sternal fixation. Ann Biomed Eng. 2007 May;35(5):808-16. doi: 10.1007/s10439-007-9272-3. Epub 2007 Mar 22.

    PMID: 17377844BACKGROUND

  • Raman J, Lehmann S, Zehr K, De Guzman BJ, Aklog L, Garrett HE, MacMahon H, Hatcher BM, Wong MS. Sternal closure with rigid plate fixation versus wire closure: a randomized controlled multicenter trial. Ann Thorac Surg. 2012 Dec;94(6):1854-61. doi: 10.1016/j.athoracsur.2012.07.085. Epub 2012 Oct 25.

    PMID: 23103010BACKGROUND

  • 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

  • Sargent LA, Seyfer AE, Hollinger J, Hinson RM, Graeber GM. The healing sternum: a comparison of osseous healing with wire versus rigid fixation. Ann Thorac Surg. 1991 Sep;52(3):490-4. doi: 10.1016/0003-4975(91)90910-i.

    PMID: 1898136BACKGROUND

  • Schimmer C, Reents W, Berneder S, Eigel P, Sezer O, Scheld H, Sahraoui K, Gansera B, Deppert O, Rubio A, Feyrer R, Sauer C, Elert O, Leyh R. Prevention of sternal dehiscence and infection in high-risk patients: a prospective randomized multicenter trial. Ann Thorac Surg. 2008 Dec;86(6):1897-904. doi: 10.1016/j.athoracsur.2008.08.071.

    PMID: 19022005BACKGROUND

  • 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

Related Links

Study Officials

  • Brian M Hatcher, PhD

    Zimmer Biomet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants are blinded to treatment choice until completion of the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison of intervention using sternal closure with 360 plating system, to closure of the sternum using wire cerclage
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 19, 2016

Study Start

July 4, 2015

Primary Completion

September 5, 2017

Study Completion

January 15, 2018

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)