Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)

Summary

The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.

Timeline

Start

2014-03

Primary completion

2018-01

Completion

2018-01

Publications

• Background Gore DR, Sepic SB. Anterior cervical fusion for degenerated or protruded discs. A review of one hundred forty-six patients. Spine (Phila Pa 1976). 1984 Oct;9(7):667-71. doi: 10.1097/00007632-198410000-00002.
• Background Palit M, Schofferman J, Goldthwaite N, Reynolds J, Kerner M, Keaney D, Lawrence-Miyasaki L. Anterior discectomy and fusion for the management of neck pain. Spine (Phila Pa 1976). 1999 Nov 1;24(21):2224-8. doi: 10.1097/00007632-199911010-00009.
• Background McConnell JR, Freeman BJ, Debnath UK, Grevitt MP, Prince HG, Webb JK. A prospective randomized comparison of coralline hydroxyapatite with autograft in cervical interbody fusion. Spine (Phila Pa 1976). 2003 Feb 15;28(4):317-23. doi: 10.1097/01.BRS.0000048503.51956.E1.
• Background Samartzis D, Shen FH, Goldberg EJ, An HS. Is autograft the gold standard in achieving radiographic fusion in one-level anterior cervical discectomy and fusion with rigid anterior plate fixation? Spine (Phila Pa 1976). 2005 Aug 1;30(15):1756-61. doi: 10.1097/01.brs.0000172148.86756.ce.
• Background Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K. Anterior fresh frozen structural allografts in the thoracic and lumbar spine. Do they work if combined with posterior fusion and instrumentation in adult patients with kyphosis or anterior column defects? Spine (Phila Pa 1976). 1995 Jun 15;20(12):1410-8.
• Background Soderlund CH, Pointillart V, Pedram M, Andrault G, Vital JM. Radiolucent cage for cervical vertebral reconstruction: a prospective study of 17 cases with 2-year minimum follow-up. Eur Spine J. 2004 Dec;13(8):685-90. doi: 10.1007/s00586-004-0747-8. Epub 2004 Jun 26.
• Background Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e.
• Background Carreon LY, Glassman SD, Campbell MJ, Anderson PA. Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J. 2010 Jun;10(6):469-74. doi: 10.1016/j.spinee.2010.02.007. Epub 2010 Apr 1.
• Background Young BA, Walker MJ, Strunce JB, Boyles RE, Whitman JM, Childs JD. Responsiveness of the Neck Disability Index in patients with mechanical neck disorders. Spine J. 2009 Oct;9(10):802-8. doi: 10.1016/j.spinee.2009.06.002. Epub 2009 Jul 25.
• Background Coric D, Nunley PD, Guyer RD, Musante D, Carmody CN, Gordon CR, Lauryssen C, Ohnmeiss DD, Boltes MO. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine. 2011 Oct;15(4):348-58. doi: 10.3171/2011.5.SPINE10769. Epub 2011 Jun 24.
• Background Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6.
• Background Lofgren H, Engquist M, Hoffmann P, Sigstedt B, Vavruch L. Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up. Eur Spine J. 2010 Mar;19(3):464-73. doi: 10.1007/s00586-009-1161-z. Epub 2009 Sep 18.
• Background Miller LE, Block JE. Safety and effectiveness of bone allografts in anterior cervical discectomy and fusion surgery. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2045-50. doi: 10.1097/BRS.0b013e3181ff37eb.
• Background Mummaneni PV, Burkus JK, Haid RW, Traynelis VC, Zdeblick TA. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. 2007 Mar;6(3):198-209. doi: 10.3171/spi.2007.6.3.198.

Drugs

Indications