Sternal Closure With SternaLock 360: First in Man Study

Sternal Fracture Clinical Trial

— SL360  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686099
• Other study ID #: 0614
• Status: Completed
• Phase: N/A
• First received: February 9, 2016
• Last updated: January 16, 2018
• Start date: July 4, 2015
• Est. completion date: January 15, 2018

Study information

• Verified date: January 2018
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 15, 2018
• Est. primary completion date: September 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sternal Fracture

Intervention

Device:
• SternaLock 360
Sternal closure with SternaLock 360
• Wire Cerclage
Sternal closure with standard wire cerclage

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Biomet	University of Cape Town

Country where clinical trial is conducted

South Africa, 

References & 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. — View Citation

Cohen DJ, Griffin LV. A biomechanical comparison of three sternotomy closure techniques. Ann Thorac Surg. 2002 Feb;73(2):563-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Mar 22. — View Citation

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. — View Citation

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. Epub 2006 Apr 25. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sternal Bone Healing	Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   "Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain (RESTORE).
•   STS Adult Cardiac Surgery Database Risk Model Variables