Neel Anand, M.D., Professor of Orthopaedic Surgery and Director of Spine Trauma at the Cedars Sinai Medical Center in Los Angeles, California, has performed the first case using a novel, demineralized bone fiber (DBF) screw anchor. He performed a deformity revision involving fixation from T11 to the ilium. In addition to using the TheraFuze DBF Fiber Anchor at 3 levels, he also used TheraFuze DBF Fiber Wraps and TheraFuze DBF FiberForm+ for 2 levels of fusion.
The supplier, Sherman Oaks, California-based TheraCell, Inc. developed this novel mesh sleeve which is made of demineralized bone fiber allograft and is designed to be placed over a pedicle screw or in a cavity prior to screw insertion. The intention is to provide increased immediate fixation strength, space filling for revision cases, and increased bone formation for long-term fixation.
"I was extremely interested to use the Fiber Anchor in this revision case because of the tremendous potential for improved fixation at the proximal and distal ends of the construct,” said Anand. He also commented that “the improved fixation was tactilely obvious” and use of the anchors easily fit into his normal surgical workflow. Anand added, “We rolled pieces of Fiber Wrap with some autologous bone graft and TheraFuze DBF containing mineralized cortical chips to make four "Burritos." It made graft placement very easy and controlled. The Fiber Anchor and the Fiber Wrap are game changers. I have additional surgeries scheduled and will continue to use the products.”
A second case was performed by Anis Mekhail, M.D., Orthopedic Spine Surgeon, and Assistant Clinical Professor of Orthopedics at University of Illinois in Chicago. Mekhail reported using Fiber Anchor for pedicle screw augmentation and plans to replace the use of polymethyl methacrylate (bone cement) in favor of the Anchor.
A third case was completed by Frank Phillips, M.D., at Rush University Medical Center in Chicago, Illinois. Phillips claimed the extra fixation offered by the “technology adds immense value in longer deformity constructs where loss of hardware fixation and resultant failure of fusion is a significant concern.”
TheraCell Chief Business Development Officer Curt Cooper described the value to the market of the Fiber Anchor as “a cost-effective solution for revision cases or where the surgeon ‘feels’ the bone quality is compromised as it provides significant improved initial in vivo fixation.”
Cooper added, “In our pre-clinical studies, the Fiber Anchor demonstrated that it promotes new bone formation in apposition to the screw with interdigitation of remodeled bone into the threads surrounded by native bone. Proud to develop a highly differentiated clinical solution, we believe the Fiber Anchor provides surgeons a novel, safe alternative to polymethyl methacrylate (PMMA).”
The company reported biophysical testing showed double the pullout strength versus screws alone. The 100% cortical bone fiber used in TheraCell DBF products are “osteoconductive with osteoinductive potential,” claims the company. As allograft-based biologics, TheraCell allograft products are not subject to regulation under the FDA 510(k) or premarket approval (PMA) pathways. All DBF products sold by TheraCell are processed by Pinnacle Transplant Technologies, a Phoenix, Arizona-based tissue bank.
TheraCell’s patented DBF products are licensed and sold by a number of other companies, including AlloSource (AlloFuse®) and NuVasive, Inc. (Propel®).
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