Sternal Closure With SternaLock 360: First in Man Study (SL360)

SternaLock 360 First in Man Study: A Prospective, Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Sternal Fracture
• Intervention / Treatment: Device: SternaLock 360; Device: Wire Cerclage

Detailed Description

The purpose of this study is to evaluate a new technology for sternal closure that combines rigid plate fixation with a cerclage material in patients undergoing a cardiac surgery subsequent to a full median sternotomy. This study will evaluate intraoperative outcomes related to the surgical technique and performance of the device, sternal healing and stability, sternal wound complications and postoperative recovery (e.g. pain and functional status) in patients closed with this device. For comparative purposes, a control group of wire cerclage patients will be included.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • Groote Schuur Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria: Pre-Operative

• 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

Exclusion Criteria: Operative

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SternaLock 360; Sternal closure performed with SternaLock 360 as a primary closure system	Device: SternaLock 360; Sternal closure with SternaLock 360
Active Comparator: Wire Cerclage; Sternal closure performed with standard wire cerclage as a primary closure system	Device: Wire Cerclage; Sternal closure with standard wire cerclage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sternal Bone Healing	Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sternal Pain	Pain scores obtained at pre-specified time points in 4 modalities: at rest, after using incentive spirometer, after ambulation and after forced coughing. Likert scale questionnaire.	Baseline, postoperative day 3 to day 7, 1-month post-op, 3-month post-op and 6-month post-op
Analgesic usage	Tabulation of all pain medication administered in pre-specified time points	Baseline, postoperative day 0 to day 7, 1-month post-op, 3-month post-op and 6-month post-op
Upper Extremities Functional Status	Functional status of upper extremities are evaluated using 20 items that are rated on a 5-point Likert scale known as Upper Extremity Functional Index questionnaire.	Baseline, 1-month post-op, 3-month post-op and 6-month post-op
Return to Work	Assessment of working status of patients before and after cardiac surgery using 7-categorical question questionnaire.	Baseline, 1-month post-op, 3-month post-op and 6-month post-op

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Collaborators: University of Cape Town
• Investigators: Study Director: Brian M Hatcher, PhD, Zimmer Biomet

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• "Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain (RESTORE).

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2015
• Primary Completion (Actual): September 5, 2017
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Sternal Closure; Rigid Fixation; Sternal Plating; Sternalock
• Other Study ID Numbers: 0614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No