By the age of 60, 90% of people will experience spinal disc degeneration [1].
This condition is marked by symptoms such as chronic back pain, reduced mobility, and nerve compression [1-2]. One of the most common treatment methods is spinal fusion surgery, which involves removing the damaged intervertebral disc and inserting a metal replacement that helps fuse the two adjacent vertebrae together [3].
Fig.1. Examples of Orthofix interbody cages, plates, and screws used in anterior and lateral lumbar fusion surgery [4-5].
The sponsor for this project, Orthofix, is a medical device company specializing in spinal hardware, orthobiologics, and surgical navigation systems. Newly developed surgical tools undergo validation testing to ensure both product performance and user safety. Previously, test engineers assessed the standalone behavior of implants. More recently, evaluating how implants affect spine range-of-motion has emerged as a promising physiologically relevant indicator of clinical effectiveness.
Our project supports the biomechanics testing workflow for product development.
The validation process involves comparing spine biomechanics before and after hardware implantation. Cadaveric spines are isolated from the body and potted in resin to secure their ends. This potting allows spines to be mounted on a test rig that applies a compressive load. After initial testing, a visiting surgeon implants the device into the spine specimen. The spine is then remounted on the test rig for post-implantation testing.
Fig.2. Current biomechanics testing workflow.
Problem: Devices that secure excised spines for surgical manipulation do not exist.
Only excised cadaveric spine specimens are compatible with test apparatuses, but the design of the potted ends can cause specimens to rock around on the surgical table. Current methods for fixing the spine include taping down the potted ends or having an additional person physically hold the potted ends in place. However, tape inhibits rotation of the spine, impeding surgeons' ability to operate. Having hands in the surgical area puts individuals at risk of being injury and can also obstruct the field of view. Broadly, these improvised systems could contribute to inconsistent hardware implantation, reducing validation data accuracy later on.
References
Columbia Neurosurgery in New York City. (2024). Degenerative Disc Disease Diagnosis & Treatment - NYC.
Cedars Sinai. (2025). Degenerative Disc Disease.
MedlinePlus Medical Encyclopedia. (2023).Spinal fusion.
Orthofix. (2025). Regatta.
Orthofix. (2025). Meridian with WaveForm A.
Page Leader: Audrey Iwashita