References
1. As demonstrated by micro-CT analysis and quantifications of bone ingrowth within cannulation of implanted screw in femoral tunnel compared to undisturbed bone in a preclinical ovine ACLR study (49.5%, stdev 12.5%). Data on File at Smith & Nephew, report NCS250. Results of in vivo simulation have not been shown to quantitatively predict clinical performance.
2. Compared to BIOSURE HA Interference Screws. Data on file at Smith & Nephew, reports 15004843, 15002832, 15002353, 15002699.
3. In vivo animal testing has demonstrated that REGENESORB Material is bioabsorbable and is replaced by bone. Implants (9x10mm) were implanted in ovine cancellous bone and compared to an empty defect (9x10mm) at 6, 12, 18 and 24 months (n=6). Micro-CT analysis demonstrated that by 24 months, bone ingrowth into this material (289.5mm3) was significantly greater (p<0.05) than bone ingrowth into an empty defect (170.2mm3) and reaches a bone volume not statistically different from intact bone (188.2mm3). Results of in vivo simulation have not been shown to quantitatively predict human clinical performance. Data on file at Smith & Nephew, report 15000897.
4. Data on file at Smith & Nephew, report NCS250.
5. Kuang GM, Yau WP, Lu WW et al. Osteointegration of soft tissue grafts within the bone tunnels in anterior cruciate ligament reconstruction can be enhanced. Knee Surg Sports Traumatol Arthrosc. 2010 Aug;18(8):1038-51. doi: 10.1007/s00167-009-0910-1. Epub 2009 Sep 25.
6. The Anterior Cruciate Ligament: Reconstruction and Basic Science. Chadwick C. Prodromos, editor. Philadelphia: Saunders; 2008. ISBN: 978-1-4160-3834-4.
7. Current Concepts in ACL Reconstruction. Freddie H. Fu and Stephen B. Cohen, editors. SLACK Incorporated NJ, USA. ISBN: 978-1556428135.
8. Anterior Cruciate Ligament Reconstruction: A Practical Surgical Guide. Siebold, Rainer, Dejour, David, Zaffagnini, Stefano, editors. Springer Science & Business, 2014 ISBN 978-3-642-45349-6.
9. Compared to BIOSURE HA Interference Screws in biomechanical studies. Results between BIOSURE REGENESORB and BIOSURE HA were not statistically significant. Data on file at Smith & Nephew, reports 15004843, 15002832, 15002353, 15002699.
10. Data on file at Smith & Nephew, report 15004843 and 15005418.
11. Compared to 7x23mm Arthrex BioComposite and 7x23mm Mitek Milagro (p<.05). Data on file at Smith & Nephew, report 15005418.
12. In vivo animal testing has demonstrated that REGENESORB Material is bioabsorbable and is replaced by bone. Implants (9x10mm) were implanted in ovine cancellous bone and compared to an empty defect (9x10mm) at 6, 12, 18 and 24 months (n=6). Micro-CT analysis demonstrated that by 24 months, bone ingrowth into this material (289.5mm3) was significantly greater (p<0.05) than bone ingrowth into an empty defect (170.2mm3) and reached a bone volume not statistically
different from intact bone (188.2mm3). Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at Smith & Nephew, report 15000897.
13. Smith & Nephew White Paper 10601161 REGENESORB: Absorbable Biocomposite Material.
14. Data on file at Smith & Nephew, reports 15000897, 15001194, 15000921, 15000919, NCS250.
15. Costantino and Friedman. Synthetic Bone Graft Substitutes (1994) Otolaryngol Clin North Am. 1994 Oct;27(5).
16. Walsh et al, (2003) Clin. Orthop. Rel. Res. Vol 406, Allison Et al (2011) US Oncology and Hematology Vol 7(1).