Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease

Summary

The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively, using Depuy ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft in conjunction with an approved Depuy Synthes pedicle screw system compared to autograft mixed with cortical/cancellous allograft in conjunction with the same DePuy Synthes pedicle screw system used for a one or two - level posterolateral lumbar fusion.

Timeline

Start

2019-03-19

Primary completion

2024-06-25

Completion

2024-06-25

Publications

• Background Boden SD. Overview of the biology of lumbar spine fusion and principles for selecting a bone graft substitute. Spine (Phila Pa 1976). 2002 Aug 15;27(16 Suppl 1):S26-31. doi: 10.1097/00007632-200208151-00007.
• Background 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.
• Background Betz RR. Limitations of autograft and allograft: new synthetic solutions. Orthopedics. 2002 May;25(5 Suppl):s561-70. doi: 10.3928/0147-7447-20020502-04.
• Background Gazdag AR, Lane JM, Glaser D, Forster RA. Alternatives to Autogenous Bone Graft: Efficacy and Indications. J Am Acad Orthop Surg. 1995 Jan;3(1):1-8. doi: 10.5435/00124635-199501000-00001.
• Background DeCoster TA, Gehlert RJ, Mikola EA, Pirela-Cruz MA. Management of posttraumatic segmental bone defects. J Am Acad Orthop Surg. 2004 Jan-Feb;12(1):28-38. doi: 10.5435/00124635-200401000-00005.
• Background DePuy Synthes. https://www.depuysynthes.com/hcp/spine/products/qs/vivigen-cellular-bone-matrix. Copyright DePuy Synthes 2014-2017. DePuy Synthes Biomaterials Division 1302 Wrights Lane East, West Chester, Pennsylvania 19380.
• Background Vaccaro AR, Stubbs HA, Block JE. Demineralized bone matrix composite grafting for posterolateral spinal fusion. Orthopedics. 2007 Jul;30(7):567-70. doi: 10.3928/01477447-20070701-06.
• Background Kang J, An H, Hilibrand A, Yoon ST, Kavanagh E, Boden S. Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions. Spine (Phila Pa 1976). 2012 May 20;37(12):1083-91. doi: 10.1097/BRS.0b013e31823ed817.

Drugs

Indications