29/03/2007
AO Technical Commission Approved

ProDisc-C

Introduction
Back pain is a leading cause for physician visits, with approximately 6080% of the US population experiencing episodes of acute low back pain at least once in their lives. While the majority of these patients improve with conservative care, a significant number become chronically debilitated and require surgical intervention. Historically, these patients are treated with fusion in lumbar spine or discectomy in cervical spine. Total disc replacement provides spine surgeons a proven alternative. Just like knee and hip arthroplasty, motion preservation of the spine is expected to make a significant impact on the surgical treatment of degenerative disc disease (DDD).

ProDisc
ProDisc was developed using the ball and socket concept successfully used in joint replacement implants for over 40 years. The ProDisc ball and socket implant design has been used clinically since 1990 and continues
to demonstrate excellent long-term clinical results. The ProDisc surgical technique, instrumentation, and implant function as a unified system. It provides a safe and reproducible implantation through a midline, mini open anterior approach. The implant is comprised of three implant componentstwo cobalt chrome alloy (CoCrMo) endplates, and an ultra-high molecular-weight polyethylene (UHMWPE) inlay. These materials have a long-term history of safe and effective use in joint replacement, which in the case of hips and knees is a much more demanding mechanical application.

ProDisc-C
When conservative attempts fail to alleviate the pain and neurological deficits caused by degenerative disc disease, the most common treatment is surgical decompression of the affected nerves and spinal cord. Cervical decompression is most often accomplished via an anterior discectomy. Discectomy involves the surgical removal of soft disc herniations that press against the spinal cord or nerve roots. Most cervical discectomies are followed by the insertion of a bone graft into the space to fuse the adjacent vertebrae together. This is known as an anterior cervical discectomy and fusion (ACDF). ACDF is considered successful when the motion at a painful motion segment is stopped. However, stopping the motion at a vertebral segment changes the mechanics of the cervical spine (which is designed for motion and flexibility). This results in the transfer of the loads and stresses to the adjacent vertebral segments and often leads to the recurrence of neck and arm pain over time. Like ACDF, cervical total disc replacement (CTDR) is intended to reduce pain by allowing for the removal of the diseased disc while restoring disc height. The difference is that CTDR also attempts to replicate a normal physiologic range of motion without increasing the stress and strain on adjacent cervical segments. The ProDisc-C total disc replacement provides the potential for motion in a single vertebral segment from C3-C7. The ProDisc-C provides for immediate fixation into the vertebral bodies through a midline keel that is orientated anterior-posterior. The bone contacting surfaces of the inferior and superior plates as well as both keels are titanium plasma spray coated to allow for long-term fixation by bony integration. Additionally, the implant is provided in a variety of sizes to allow the surgeon to accurately match the patients anatomy.

In the US, the ProDisc-C recently completed the 2 year follow-up of a multicenter, prospective, randomized, controlled clinical trial. The purpose of the trial was to compare the safety and effectiveness of ProDisc-C to traditional spinal fusion surgery for the treatment of symptomatic degenerative disc disease in the C3-C7 cervical vertebral segments. Over 200 patients were randomized to ProDisc-C or ACDF surgery in a 1:1 ratio. 15 clinical sites were selected to assess the primary endpoints of the study which included key clinical outcomes such as the neck disability index (NDI), neurologic parameters, and removal or revision rates. The results of this study will be available soon.

Hazards and labeling

Due to varying countries’ legal and regulatory approval requirements, consult the appropriate local product labeling for approved intended use of the products described on this website. All devices on this website are approved by the AO Technical Commission. For logistical reasons, these devices may not be available in all countries worldwide at the date of publication. 


Legal restrictions

This work was produced by AO Foundation, Switzerland. All rights reserved by AO Foundation. This publication, including all parts thereof, is legally protected by copyright.

Any use, exploitation or commercialization outside the narrow limits set forth by copyright legislation and the restrictions on use laid out below, without the publisher‘s consent, is illegal and liable to prosecution. This applies in particular to photostat reproduction, copying, scanning or duplication of any kind, translation, preparation of microfilms, electronic data processing, and storage such as making this publication available on Intranet or Internet.

Some of the products, names, instruments, treatments, logos, designs, etc referred to in this publication are also protected by patents, trademarks or by other intellectual property protection laws (eg, “AO” and the AO logo are subject to trademark applications/registrations) even though specific reference to this fact is not always made in the text. Therefore, the appearance of a name, instrument, etc without designation as proprietary is not to be construed as a representation by the publisher that it is in the public domain.

Restrictions on use: The rightful owner of an authorized copy of this work may use it for educational and research purposes only. Single images or illustrations may be copied for research or educational purposes only. The images or illustrations may not be altered in any way and need to carry the following statement of origin “Copyright by AO Foundation, Switzerland”.

Check www.aofoundation.org/disclaimer for more information.

 

If you have any comments or questions on the articles or the new devices, please do not hesitate to contact us


"approved by AO Technical Commission" and "approved by AO Foundation"

The brands and labels "approved by AO Technical Commission" and "approved by AO Foundation", particularly "AO" and the AO logo, are AO Foundation's intellectual property and subject to trademark applications and registrations, respectively. The use of these brands and labels is regulated by licensing agreements between AO Foundation and the producers of innovation products obliged to use such labels to declare the products as AO Technical Commission or AO Foundation approved solutions. Any unauthorized or inadequate use of these trademarks may be subject to legal action.

2020 IM covers

AO TC Innovations Magazine

Find all previous issues of the AO TC Innovations Magazine for download here.

Meet the Experts

Directly learn about AO Approved Solutions from the Experts themselves.

Innovation Awards

Innovation awards

Recognizing and fostering excellence in surgical innovation.

X
Cookies help us improve your website experience.
By using our website, you agree to our use of cookies.
Confirm