A novel, bone fiber based graft was implanted for the first time by Neel Anand, M.D., Mch. Orth., professor of Orthopaedic Surgery and director, Spine Trauma, Cedars Sinai Medical Center, and chairman of Orthopaedics and Spine, Minimally invasive Spine Surgery, DOCS Surgical Hospital, Beverly Hills. The surgery performed was an L3-L4 PSF with an interbody TLIF (transforaminal lumbar interbody fusion) at L3-L4.
The graft material, unlike other allograft bone grafts currently on the market, is comprised of long and strong fibers whose particular topology which, says the processing company TheraCell, Inc., encourages cell adhesion and proliferation. The 100% cortical demineralized bone allograft is brand named TheraFuze DBF Fiber Bullets. The processing method, according to TheraCell CEO Brad Patt, Ph.D., is completely patent protected and was originally conceived in 2013 and first put into production in 2016.
Dr. Anand described using the novel bone graft to OTW: “After discectomy and endplate preparation to accept the TLIF cage, I placed several Fiber Bullets in the lyophilized state anterior to the implant to fill the interbody space with graft material. Subsequent to the cage insertion, several additional Fiber Bullets were placed posterior to the cage to ensure complete endplate to endplate apposition of the TheraFuze DBF allograft in the interbody. I placed 1cc of DBF FiberForm combined with autograft in the lumen of the TLIF cage.”
TheraCell CEO Patt explained why this graft is so unique. “While all other fibers on the market are formed by fractionating brittle cortical bone in a high-pressure milling process, and then demineralizing the fragments, we demineralize bone struts, rendering them soft.”
“These softer bone struts can then be cut using low pressure cutting methods which result in several advantages, namely: 1) The fibers are of equal diameter and length with over 93% yield. This better honors the gift of donated tissue. 2) The native nano-topology of the collagen fibrils is also preserved yielding an allograft that is more cell friendly and which encourages cell adhesion and proliferation.”
Andy Carter, Ph.D., TheraCell’s chief technology officer, told OTW, “Having a method for producing uniform fiber geometry we realized that we had a process that gave us the ability to use the fibers as a Bone Textile input. That afforded us the capability of making highly novel two- and three-dimensional structures. We started to look at how this could be used to deliver procedure specific solutions that would address identified surgeon needs to improve the surgical technique and ultimately patient outcomes.”
“Having these qualities available and having identified the need for methods to get allograft materials into cavities in a minimally invasive manner, and potentially down a narrow tube through a small incision, over several years we developed a strategy for thin cylindrical implants that could be loaded into a cannula and delivered easily. It is great to see these products now in use clinically.”
“The emergence of fibers did not immediately suggest a solution because it is hard to get fibers to go down a tube. Dr. Nelson Scarborough (TheraCell chief science office and inventor of the original Osteotech fiber technology and also co-author with Dr. Scott Boden of the seminal paper showing the advantages of fiber versus DBM) suggested a construct like the bullet.”
