29/03/2007
AO Technical Commission Approved

ProDisc-L

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-L
Patients with degenerative disc disease (DDD) in lumbar spine are often treated with spinal fusion. While some patients do well after fusion, there are a significant number that do not find pain relief or go on to experience long-term degenerative changes from the rigid immobilization of their spine.

The ProDisc-L total disc replacement is indicated for spinal arthroplasty in skeletally mature patients with DDD at one level from L3-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than grade 1 degenerative spondylolisthesis at the involved level. Patients receiving the ProDisc-L total disc replacement should have failed at least 6 months of conservative treatment prior to implantation of the ProDisc-L total disc replacement.

An FDA Investigation Device Exemption (IDE) clinical study with Pro-Disc-L was started in 2001 in the USA. The IDE study for single-level indications involved nearly 300 patients at 17 centers across the USA, comparing ProDisc-L to circumferential fusion. The study showed that ProDisc-L is a safe and reproducible procedure with a minimal learning curve. The patients were more satisfied with the ProDisc-L total disc replacement than fusion (81% satisfaction vs 69% for fusion). 94% of ProDisc-L patients had a normal range of motion at 24 months. ProDisc-L patients have significantly greater improvement in ODI scores than fusion patients (46% improvement over baseline vs 38% for fusion).

Case 1

44-years-old Firefighter2 years of increased low back pain

 

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