Claiming to overcome current challenges in graft containment and handling of cell-based tissue forms, on July 1, 2013 Orthofix International NV announced the full market release of Trinity Elite.
Orthofix Allograft Promises Better Handing
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Trinity Elite Allograft with Viable Cells and VersaShield Amniotic Membrane tissue forms will be distributed through the company’s Spine Fixation and U.S. Extremity Fixation distribution channels. The market release was announced in collaboration with the Musculoskeletal Transplant Foundation (MTF). MTF is credited with developing the unique feature of being fully moldable by the user.
“In my initial usage of Trinity Elite, I have been extremely satisfied with the ability to pack more graft material into a disc space during a posterior lumbar interbody fusion procedure, as well as posterior laterally. In addition, this novel allograft represents a new option for surgeons who want to apply a cell-based allograft to the lateral gutter and lay it flat along the transverse process, ” said Peter Shedden, MSc., M.D., FRCS, FACS, FAANS of the Greater Houston Neurosurgery Center in the Woodlands, Texas. Dr. Shedden is also a member of the company’s medical education team.
According to the company press release, the product is a third generation allograft with viable cells and provides surgeons with an alternative to autograft and builds on more than 75, 000 Trinity Evolution procedures. Trinity Evolution is an allograft of cancellous bone containing viable adult stem cells and osteoprogenitor cells within the matrix and a demineralized bone component. VersaShield is a thin hydrophilic amniotic membrane designed to serve as a wound covering and is derived from the human placental layers, amnion and chorion. These thin elastic membranes allow the tissue form to conform to the surface or surgical site.
Trinity Elite will be available in four different quantities.
Brad Mason, Orthofix’s president and CEO, said initial feedback from early adopters has been “universally and extremely positive.” Bruce Stroever, MTF’s CEO said the five-year partnership with Orthofix has proven to be a successful endeavor. “We plan to continue being innovators in this space, ” added Mason.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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