An Alternative to Lumbar Fusion
prodisc L Total Disc Replacement
Neck and Cervical Spine Anatomy
The vertebral bodies encase the spinal cord to provide protection. When stacked on top of each other, they form the spinal column which provides stability for the head and upper body. The spinal cord and the nerve exits are located within the spinal canal.
The intervertebral discs are located between the vertebral bodies. These discs cushion shock forces, acting as “shock absorbers”. The discs in conjunction with the vertebral joints facilitate motion by turning, stretching and bending of the neck.
prodisc L has a very long clinical history (25+ years) and has been widely used throughout the world. The prodisc line of total disc replacements (TDRs) are the most widely studied TDRs, with over 400 peer-reviewed published studies, reporting on over 13,000 patients. The first implantation of a prodisc L took place in 1990, and the second generation design received US PMA approval in 2006.
This page outlines some of the clinical studies, biomechanical, and cost-effectiveness evaluations that have been published on prodisc L.
No other disc replacement system has been studied more: nearly 40% of all TDR papers report on prodisc. More published lives than for any other system with over 13,000 patients reported on in over 400 articles.
- The prodisc design has been validated with over 125,000 device implantations and a reported reoperation rate of less than 1%.
prodisc L Goals
Maintain Spinal Balance and Motion
Degenerative disc disease can destabilize segments over time. In addition, performing the surgical discectomy is inherently destabilizing, as it involves the removal of the Anterior Longitudinal Ligament, the disc, and often, the Posterior Longitudinal Ligament. In the absence of these restricting structures, it is
important for a disc replacement to have constraints in order to protect the facet joints.
Controlled and Predictable Motion
- Allows a normal range of motion while providing segmental stability through controlled translation.
- Highly conforming surfaces of the superior endplate and UHMWPE inlay prevent the endplates from translating independently.
- Translation is provided by rotation of the superior endplate around the ball on the inferior endplate.
Range of Motion
- The prodisc C is designed to allow for a normal range of motion in flexion /extension, lateral bending, and axial rotation.*
* L5, LD5, XL5 and XLD5 sizes allow 17.5° in flexion / extension and lateral bending.
Decelerate Adjacent Level Reoperations
The historical treatment for degenerative disc disease is to conduct an ACDF and fuse the joint. However, immobilizing a segment of the spine has been shown to increase the rate of adjacent-level degeneration. By enabling motion, prodisc is intended to decelerate adjacent level degeneration. A paper published on the results with the US IDE PMA clinical study on prodisc showed that, at seven years follow-up, patients had four times fewer reoperations of adjacent segments, compared to patients that received an ACDF.
Range of Motion
- The prodisc C is designed to allow for a normal range of motion in flexion /extension, lateral bending, and axial rotation.1
- Long-term prospective randomized multi-center evidence illustrates that patients retained range of motion of 8.12° for 7 years.1
- Fusion patients from the study had a range of motion of 0.66°.1
1 Janssen ME, et al, ProDisc-C Total Disc Replacement Versus ACDF for Single-Level Symptomatic Cervical Disc Disease, JBJS, 2015, 97:1738-47.
Accelerate the Resumption of Activities of Daily Living
The operative procedure to conduct a discectomy can be invasive and require recuperation. Special care has been taken to design the technique and instrumentation to minimize the recovery associated with the procedure. A review of nearly 7,000 patients in the Blue Health Intelligence Claims Database showed that patients who received a prodisc C experienced significantly shorter length of hospital stays compared to patients who received an ACDF.2