Clinical trial NCT03407560 - References

Spinal Fusion — Use of the Bone Substitute SintLife® in Vertebral Arthrodesis Procedures. A Pilot Study.

Citation(s)

•   Abdullah KG, Steinmetz MP, Benzel EC, Mroz TE
  The state of lumbar fusion extenders. Spine (Phila Pa 1976). 2011 Sep 15;36(20):E1328-34. doi: 10.1097/BRS.0b013e318209952b.
•   Alsaleh KA, Tougas CA, Roffey DM, Wai EK
  Osteoconductive bone graft extenders in posterolateral thoracolumbar spinal fusion: a systematic review. Spine (Phila Pa 1976). 2012 Jul 15;37(16):E993-1000. doi: 10.1097/BRS.0b013e3182518859.
•   Barbanti Brodano G, Griffoni C, Zanotti B, Gasbarrini A, Bandiera S, Ghermandi R, Boriani S
  A post-market surveillance analysis of the safety of hydroxyapatite-derived products as bone graft extenders or substitutes for spine fusion. Eur Rev Med Pharmacol Sci. 2015 Oct;19(19):3548-55.
•   Brodano GB, Giavaresi G, Lolli F, Salamanna F, Parrilli A, Martini L, Griffoni C, Greggi T, Arcangeli E, Pressato D, Boriani S, Fini M
  Hydroxyapatite-Based Biomaterials Versus Autologous Bone Graft in Spinal Fusion: An In Vivo Animal Study. Spine (Phila Pa 1976). 2014 May 15;39(11):E661-E668. doi: 10.1097/BRS.0000000000000311.
•   Carragee EJ, Hurwitz EL, Weiner BK
  A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J. 2011 Jun;11(6):471-91. doi: 10.1016/j.spinee.2011.04.023.
•   Dai LY, Jiang LS
  Single-level instrumented posterolateral fusion of lumbar spine with beta-tricalcium phosphate versus autograft: a prospective, randomized study with 3-year follow-up. Spine (Phila Pa 1976). 2008 May 20;33(12):1299-304. doi: 10.1097/BRS.0b013e3181732a8e.
•   Dimar JR 2nd, Glassman SD, Burkus JK, Pryor PW, Hardacker JW, Carreon LY
  Two-year fusion and clinical outcomes in 224 patients treated with a single-level instrumented posterolateral fusion with iliac crest bone graft. Spine J. 2009 Nov;9(11):880-5. doi: 10.1016/j.spinee.2009.03.013. Epub 2009 May 17.
•   Fischer CR, Cassilly R, Cantor W, Edusei E, Hammouri Q, Errico T
  A systematic review of comparative studies on bone graft alternatives for common spine fusion procedures. Eur Spine J. 2013 Jun;22(6):1423-35. doi: 10.1007/s00586-013-2718-4. Epub 2013 Feb 26.
•   Gao C, Deng Y, Feng P, Mao Z, Li P, Yang B, Deng J, Cao Y, Shuai C, Peng S
  Current progress in bioactive ceramic scaffolds for bone repair and regeneration. Int J Mol Sci. 2014 Mar 18;15(3):4714-32. doi: 10.3390/ijms15034714.
•   Gruskay JA, Basques BA, Bohl DD, Webb ML, Grauer JN
  Short-term adverse events, length of stay, and readmission after iliac crest bone graft for spinal fusion. Spine (Phila Pa 1976). 2014 Sep 15;39(20):1718-24. doi: 10.1097/BRS.0000000000000476.
•   Gupta A, Kukkar N, Sharif K, Main BJ, Albers CE, El-Amin Iii SF
  Bone graft substitutes for spine fusion: A brief review. World J Orthop. 2015 Jul 18;6(6):449-56. doi: 10.5312/wjo.v6.i6.449. eCollection 2015 Jul 18.
•   Hsu WK, Nickoli MS, Wang JC, Lieberman JR, An HS, Yoon ST, Youssef JA, Brodke DS, McCullough CM
  Improving the clinical evidence of bone graft substitute technology in lumbar spine surgery. Global Spine J. 2012 Dec;2(4):239-48. doi: 10.1055/s-0032-1315454. Epub 2012 Oct 9.
•   Kaiser MG, Groff MW, Watters WC 3rd, Ghogawala Z, Mummaneni PV, Dailey AT, Choudhri TF, Eck JC, Sharan A, Wang JC, Dhall SS, Resnick DK
  Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: bone graft extenders and substitutes as an adjunct for lumbar fusion. J Neurosurg Spine. 2014 Jul;21(1):106-32. doi: 10.3171/2014.4.SPINE14325.
•   Kannan A, Dodwad SN, Hsu WK
  Biologics in spine arthrodesis. J Spinal Disord Tech. 2015 Jun;28(5):163-70. doi: 10.1097/BSD.0000000000000281.
•   Kho VK, Chen WC
  Posterolateral fusion using laminectomy bone chips in the treatment of lumbar spondylolisthesis. Int Orthop. 2008 Feb;32(1):115-9. doi: 10.1007/s00264-006-0274-9. Epub 2006 Dec 19.
•   Kim DH, Rhim R, Li L, Martha J, Swaim BH, Banco RJ, Jenis LG, Tromanhauser SG
  Prospective study of iliac crest bone graft harvest site pain and morbidity. Spine J. 2009 Nov;9(11):886-92. doi: 10.1016/j.spinee.2009.05.006. Epub 2009 Jun 18.
•   Korovessis P, Koureas G, Zacharatos S, Papazisis Z, Lambiris E
  Correlative radiological, self-assessment and clinical analysis of evolution in instrumented dorsal and lateral fusion for degenerative lumbar spine disease. Autograft versus coralline hydroxyapatite. Eur Spine J. 2005 Sep;14(7):630-8. doi: 10.1007/s00586-004-0855-5. Epub 2005 Mar 24.
•   Lee JH, Hwang CJ, Song BW, Koo KH, Chang BS, Lee CK
  A prospective consecutive study of instrumented posterolateral lumbar fusion using synthetic hydroxyapatite (Bongros-HA) as a bone graft extender. J Biomed Mater Res A. 2009 Sep 1;90(3):804-10. doi: 10.1002/jbm.a.32113.
•   Ludwig SC, Kowalski JM, Boden SD
  Osteoinductive bone graft substitutes. Eur Spine J. 2000 Feb;9 Suppl 1(Suppl 1):S119-25. doi: 10.1007/pl00008317.
•   Manfrini M, Di Bona C, Canella A, Lucarelli E, Pellati A, D'Agostino A, Barbanti-Brodano G, Tognon M
  Mesenchymal stem cells from patients to assay bone graft substitutes. J Cell Physiol. 2013 Jun;228(6):1229-37. doi: 10.1002/jcp.24276. Erratum In: J Cell Physiol. 2013 Oct;228(10):2095-6.
•   Miyazaki M, Tsumura H, Wang JC, Alanay A
  An update on bone substitutes for spinal fusion. Eur Spine J. 2009 Jun;18(6):783-99. doi: 10.1007/s00586-009-0924-x. Epub 2009 Mar 12.
•   Nickoli MS, Hsu WK
  Ceramic-based bone grafts as a bone grafts extender for lumbar spine arthrodesis: a systematic review. Global Spine J. 2014 Aug;4(3):211-6. doi: 10.1055/s-0034-1378141. Epub 2014 Jun 9.
•   Park JJ, Hershman SH, Kim YH
  Updates in the use of bone grafts in the lumbar spine. Bull Hosp Jt Dis (2013). 2013;71(1):39-48.
•   Rajaee SS, Bae HW, Kanim LE, Delamarter RB
  Spinal fusion in the United States: analysis of trends from 1998 to 2008. Spine (Phila Pa 1976). 2012 Jan 1;37(1):67-76. doi: 10.1097/BRS.0b013e31820cccfb.
•   Yoshihara H, Yoneoka D
  National trends in the surgical treatment for lumbar degenerative disc disease: United States, 2000 to 2009. Spine J. 2015 Feb 1;15(2):265-71. doi: 10.1016/j.spinee.2014.09.026. Epub 2014 Oct 2.
•   Zhou H, Lee J
  Nanoscale hydroxyapatite particles for bone tissue engineering. Acta Biomater. 2011 Jul;7(7):2769-81. doi: 10.1016/j.actbio.2011.03.019. Epub 2011 Apr 1.

Use of the Bone Substitute SintLife® in Vertebral Arthrodesis Procedures. A Pilot Study.

Details for clinical trial NCT03407560