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| Name | Class |
|---|---|
| University of Cape Town | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SternaLock 360 | Experimental | Sternal closure performed with SternaLock 360 as a primary closure system |
|
| Wire Cerclage | Active Comparator | Sternal closure performed with standard wire cerclage as a primary closure system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SternaLock 360 | Device | Sternal closure with SternaLock 360 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sternal Bone Healing | Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria: Pre-Operative
Exclusion Criteria: Operative
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| Name | Affiliation | Role |
|---|---|---|
| Brian M Hatcher, PhD | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groote Schuur Hospital | Cape Town | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10333037 | Background | 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. | |
| 11845875 | Background | 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. |
| Label | URL |
|---|---|
| "Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain (RESTORE). | View source |
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Comparison of intervention using sternal closure with 360 plating system, to closure of the sternum using wire cerclage
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participants are blinded to treatment choice until completion of the study.
| Wire Cerclage |
| Device |
Sternal closure with standard wire cerclage |
|
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 |
| 21760857 | Background | 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. |
| 17006079 | Background | 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. |
| 17888985 | Background | 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. |
| 14726062 | Background | 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. |
| 11576043 | Background | 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. |
| 17377844 | Background | 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. |
| 23103010 | Background | 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. |
| 17670585 | Background | 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. |
| 1898136 | Background | 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. |
| 19022005 | Background | 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. |
| 15296898 | Background | 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. |