prodisc USAGE

The 1^st implantation of a prodisc L took place in 1990, and the 2^nd generation design received US PMA approval in 2006.

With such a lengthy clinical history and global usage, the prodisc line of total disc replacements are the most widely studied TDRs in the world.

30+
30+ Year Clinical History with Worldwide Usage

prodisc design has been validated with over 225,000 device implantations worldwide¹ and more than 540 published papers²

2L
The only total disc replacement system in the U.S. approved for two-level use in the lumbar spine

More than 225,000 device implantations and a reported reoperation rate of less than 1%

prodisc DESIGN

The prodisc design is based on two critical principles: a mechanism of action & post-operative fixation.

Mechanism of Action

The prodisc implant is a ball and socket design with a fixed center of rotation. This patented design has been in clinical use since 1990 and utilized across the entire product platform. The fixed center of rotation allows physiological range of motion while providing stability to the spine and significantly reducing reoperations at the adjacent levels.

disc replacement designed to resist shear forces

Fixation

Immediate Post-Operative Fixation
Immediate post-operative fixation is provided by the midline keels, ensuring the implant is securely held in place so the patient can begin rehabilitation and return to their normal activities as soon as possible.

Long-Term Fixation
The entire surface of the implant that is in contact with the vertebra is coated with a highly porous plasma sprayed titanium coating. This allows for bony on-growth into the porous surface of the implant for long term, secure fixation.

prodisc OBJECTIVES

prodisc was developed with several specific patient care objectives in mind:

Maintaining Spinal Motion

Degenerative disc disease can destabilize your spine. In order to protect adjacent segments of the spine from diseased segments, prodisc is designed with a fixed center of motion, enabling translation only with bending motion.

Controlled & Predictable Motion
Unlike other designs, prodisc is designed to enable physiologic motion in the degenerated spine.

Range of Motion
prodisc allows a normal range of motion while providing stability through controlled translation.

Reducing Adjacent Level Disease

The ‘gold standard’ for treating degenerative disc disease is to conduct a fusion and fuse the joint. However, immobilizing a segment of the spine has been shown to increase the rate of adjacent level degeneration. prodisc has been shown in multiple long-term studies to decrease the development of adjacent level disease.³

Range of Motion
Long-term prospective randomized multi-center evidence illustrated patients retained range of motion of 8.12° at 7 years.³

Resuming Activities of Daily Living

Degenerative disc disease can be very painful, and recovery from spinal surgery can take time. Special care has been taken to design prodisc to minimize the recovery associated with the procedure. In a study comparing prodisc and fusion, surgeons found that patients that received the fusion treatment option lost nearly twice as much blood during the procedure, spent nearly twice as much time in the OR, and had longer hospital stays.

Patented Midline Keel

The prodisc keel is specifically designed to provide immediate stability, making post-op bracing optional.
A study on military personnel (over 50% of the participants were Navy SEALs) found that 83% returned to active duty after receiving a prodisc L versus 67% that had received an ALIF.⁴

prodisc STUDIES

No other disc replacement system has been studied more than prodisc.

With more than 540 published papers, reporting on experiences with over 13,000 patients, the clinical data for prodisc strongly supports its safety and effectiveness. Here are just a few key takeaways from these numerous clinical studies:

Fewer Reoperations

After 7 Years with prodisc C vs. Patients that Received a Fusion (ACDF)³

Less Likely Adjacent Level Degeneration

After 5 Years with prodisc L vs. Patients that Received a Fusion (ALIF)⁵

LOWER

Change in Range of Motion

Shown in Biomechanical Study of prodisc C vs. a Plate-Based Fusion (ACDF)⁶

MORE treatment options

Total Disc Replacement vs. Spinal Fusion

Though Total Disc Replacement (TDR) offers many benefits, it’s not always the best solution for everyone. For those who are not good candidates for TDR, there are alternatives available. Currently, there is a nationwide clinical trial investigating two devices compared to TDR. The most common alternative recommended right now is spinal fusion, a degenerative disc disease treatment that can stabilize and secure the spine.

While a total/artificial disc replacement involves removing the painful disc and putting in a prosthetic implant, spinal fusion creates a direct bony connection between the vertebrae around the painful disc, stopping the motion that’s causing discomfort. The factors that can help determine which surgery is right for you include where your pain is located, your surgical history and/or other spinal problems, your weight, and whether you have significant joint disease or compression on the nerves of your spine.

Total Disc Replacement

Spinal Fusion

WORKING WITH your insurer

The Patient Assistance Line

While the vast majority of insurance plans cover prodisc, there are a few policies that list it as a non-covered procedure despite the long term clinical evidence. Centinel Spine offers a Patient Assistance Line (PAL) to patients to help them to navigate insurance coverage for this surgery.

The PAL service is dedicated to assisting YOU and will work with your surgeon, medical office, and insurance provider to facilitate coverage.

For further assistance, view the prodisc L Patient Advocacy Guide:

Download the Guide

Call (800) 264-4623

Monday - Friday

9am - 5pm EST

Important Patient Information: The resources provided on this site are for informational purposes only. This website is not a replacement for professional medical advice. You should discuss both surgical and nonsurgical treatment options with your doctor. Only your doctor is qualified to diagnose and treat your condition.

Problems can occur when you have spine surgery, including surgery with prodisc implants. There is a risk that the surgery may not make you feel better or may cause you to feel worse. If this happens, you may need another surgery to help you feel better. View the specific problems that can occur during or after prodisc L or prodisc C surgery.

Reimbursement is dynamic. Coding, coverage and payment are subject to change. Centinel Spine cannot guarantee reimbursement for any procedure associated with the use of its products. Providers should contact their specific payers if they have questions regarding coding, coverage or payment.

¹ Data on file at Centinel Spine compiled from Spine Solutions, Synthes Spine, DePuy Synthes, and Centinel Spine.
² Search performed on Pubmed, Embase, Ovid Medline^® covering 1988 – 2018.
³ Janssen ME, et al, ProDisc-C Total Disc Replacement Versus ACDF for Single-Level Symptomatic Cervical Disc Disease, JBJS, 2015, 97:1738-47.
⁴ Tumialan, L.M., et al., Arthroplasty in the military: a preliminary experience with prodisc C and prodisc L. Neurosurgical focus, 2010. 28(5): p. E18.
⁵ Zigler, J, Delamarter R, Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the prodisc L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease, J Neurosurg Spine, 2012, 17:493-501.
⁶ Crawford NR, et al, Biomechanics of a Fixed-Center of Rotation Cervical Intervertebral Disc Prosthesis, Int J Spine Surg. 2012; 6: 34–42.

They Regained Their Lives

These individuals can inspire your journey to healing and life after disc replacement surgery—and the hope of freedom from spine-induced pain and discomfort.