Impact of a Novel Patient-Specific, Patient-Matched Bezier Parametric Curve Rod Platform on Proximal Junction Biomechanics in an in Silico Thoracolumbar Fusion Model

FORT LAUDERDALE, Fla., Dec. 5, 2024 /PRNewswire/ -- The results of a study released today by Spinal Resources Inc. demonstrate Bezier Parametric Curve Transition Rods offer a smoother load transition and reduced stress on proximal segments. They also reduce disc stress at the UIV. This ability to address the overall stiffness leads to a global construct benefit while still providing necessary correction.

Excessive stiffness may contribute to complications such as stress shielding, implant loosening and Proximal Junctional Kyphosis (PJK). PJK is a well-recognized complication in spinal deformity surgery, occurring in 6% to 62% of patients with potential added treatment costs of $55,547 - $193,277  (Alvarez Reyes et al. 2022; Cho, Shin, and Kim 2014; Han et al. 2017; Theologis et al. 2016; Safaee et al. 2018).

While PJK is a multifactorial challenge, the stiffness of the construct, influenced by the choice of rods, is a risk factor that the surgeon can control. Bezier Parametric Curve Transition Rods achieve stiffness adjustment by varying the rod's section diameter along specific lengths and segment orders. This is accomplished through the strategic placement of Bezier Zones throughout the rod, enabling precise control over stiffness distribution.

A customizable patient-matched platform utilizes a precision manufacturing process to provide spinal 3D correction capabilities while minimizing proximal construct stresses along with overall reduction in construct stiffness. Bezier rods offer surgeons control and may offer superior performance in terms of reducing the risk of (PJK) compared to conventional rod designs.

According to surgeon and researcher Dr. Zach Tempel (Mayfield Clinic), "Bezier rods are patient-specific and patient matched and are designed with greater stiffness where needed for different clinical applications while maintaining flexibility near the upper instrumented vertebra to promote a biomechanical "soft landing" at the junction of instrumented and native spine. This innovative rod design alleviates biomechanical stress at the instrumented-non-instrumented transition, thereby lowering PJK incidence while maintaining robust correction capabilities." 

Dr. Tempel continues, "The Bezier rod portfolio offers a unique solution for deformity surgeons who appreciate a tailored approach for complex patients. Despite the rapid evolution of our field, with respect to biomechanics and the importance of geometric parameters, the current industry players provide surprisingly limited options, exposing an Achilles heel for deformity operations. With a wide range of stiffness combinations in the preservation of strength across transitional zones, the Bezier rod portfolio represents a major step in the evolution of rod customization to address overall construct stiffness and not just a proximal failure point."

Adult and Pediatric Spine Surgeon Dr. Amit Jain (John's Hopkins) recently commented, "As someone who takes care of pediatric and adult patients with spinal problems, I am always thinking about ways to reduce stresses at adjacent levels. This is particularly important in the pediatric population, as kids have a lifetime ahead. Thus, it's important to be conscientious in their care. The Bezier rod caught my attention as it allows mitigation of these stresses throughout the overall construct leading to desired results at ends of the construct."

Bernie Bedor, President and Chief Executive Officer of Spinal Resources Inc. concludes, "Spinal Resources patient-specific and patient-matched rods enable the surgeon to always bring the rod to the patient rather than forcing the patient into a preoperative rod bend when intra–operative changes occur. The Bezier platform provides solutions to allow for deviation from the preoperative plan, giving the surgeon total control of the procedure.

The Bezier technology is also applicable to degenerative applications, providing a potential benefit by reducing the risk of high stress or disease progression in adjacent segments above the lumbar spine. Our goal is to treat these matters globally by addressing the overall construct to yield a better outcome locally."

About Spinal Resources Inc.
Spinal Resources Inc.^® is a Florida-based spinal medical device company that supports cost-effective patient care with innovative mechanical and bio-mechanical products to alleviate pain, shorten recovery time, restore health, and extend quality of life.

Click this link to read or download the white paper.

For more information, visit
www.spinalresourcesinc.com

SOURCE Spinal Resources Inc.