Artificial Disc Replacement Surgery (ADR) Has Become the Standard of Care Vs. ACDF

What Is Artificial Disc Replacement Surgery?

Simply put, Artificial Disc Replacement (ADR) surgery removes and replaces diseased discs in the neck to treat cervical spine problems while maintaining motion.  Traditionally, the same patient would have received a fusion, commonly an Anterior Cervical Discectomy and Fusion (ACDF).  ACDF remains highly effective, however it requires fusion after removing diseased discs in the neck.  The fusion is designed to stop movement at the operated levels.

Early research into artificial disc replacement began in the 1960s because of the complications sometimes caused by spinal fusion. Insurance coverage changes over the last few years have enabled more and more patients to receive this alternative procedure to become the fastest growing procedure in spine; representing nearly 10% of fusions.
 
Cervical TDR-ADR has a very high Neck Disability Index (NDI) success rate compared to ACDF – and motion is preserved!
During disc replacement surgery, Dr. Larson removes your damaged disc and replaces it with an artificial disc. The goals of total disc replacement surgery are to maintain spinal balance and motion, reduce adjacent level degeneration and allow patients to get back to activities of daily living.
 
Disc replacement surgery is performed by Dr. Larson in either the cervical or neck region of the spine, or in the lumbar or lower back region. The surgical approach for the neck and lower back is through the front, referred to as an anterior approach. Disc replacement surgery starts with surgical access to the spine, followed by removal of the patient’s diseased disc. Once the diseased disc has been removed, the total disc replacement is implanted.

Prodisc-C

The OG

Mobi-C

FDA Approved ADR for 1 and 2 Levels

M6

A Viscoelastic Cervical Disc

Simplify

FDA Approved ADR for 1 and 2 Levels – PEEK vs. Metal

Mobi-C

What Is A Mobi-C Cervical Disc

Mobi-C® Cervical Disc replaces diseased discs in the neck and is designed to maintain motion.  Traditionally, the same patient would have received a fusion. Fusion surgery, while also replacing diseased discs in the neck, is designed to stop movement at the operated levels.

How It Works

Mobi-C contains patented mobile bearing technology that allows the polyethylene core to slide and rotate inside the disc for self-adjustment to the cervical spine movements. This means that Mobi-C can react to the normal motion in the cervical spine.

Mobi-C provides bone sparing fixation without chisel cuts into the small vertebral bodies of the cervical spine, making it bone sparing.

Mobi-C Facts

Where is Mobi-C used?

The Mobi-C Cervical Disc is one of the most widely used cervical discs in the world. First implanted in France in November 2004, Mobi-C has now been implanted in more than 75,000 spinal levels in 25 countries.

Is Mobi-C FDA approved?

Mobi-C entered an FDA clinical trial in 2006, in which 647 levels of Mobi-C were implanted. A total of 599 patients were involved in the clinical trial at 24 study centers across the U.S.  This represents the largest clinical trial ever conducted in the U.S. for cervical disc replacement.  Mobi-C received FDA approval in August of 2013, making it the first cervical disc with both one and two-level indications.

What is Mobi-C made of?

Mobi-C is made with two Cobalt Chromium alloy endplates that are plasma sprayed with titanium and coated with hydroxyapatite, and has an Ultra High Molecular Weight Polyethylene plastic insert (UHMWPE). These are proven materials that have been used in orthopedic applications for over 60 years.

Who is a candidate?

Mobi-C is intended for adult patients (skeletally mature) with arm pain and/or neurological symptoms (such as weakness or numbness) with or without neck pain at one or two adjacent levels from C3 – C7 in the cervical spine. Patients should have failed non-surgical care (such as physical therapy or medications) for at least 6 weeks, or shown signs of progressively worsening symptoms.  Disc damage needs to be confirmed by a doctor’s review of CT, MRI, or x-ray images.  A doctor should always be consulted for proper indications and use of Mobi-C.

Here’s How It Works

Prodisc C

What Is A Prodisc C

TOTAL DISC REPLACEMENT

The treatment goal of the prodisc C Total Disc Replacement is to restore the normal dynamic function of the spine and to significantly reduce pain.

The function of the spine is restored through the mechanism of action of the device.  Pain reduction is achieved through the re-establishment of the disc height, and maintained by the prosthesis. The increase in height and the elimination of the herniated disc “opens” constricted nerve paths and the vertebral joints are restored to their physiological position.

Prior to the development of artificial discs the only surgical option was a fusion, in which adjacent vertebral bodies are “fused together” permanently using implants, bone chips and/or cages. The goal of prodisc C is to maintain mobility at the affected intervertebral disc and to reduce the extra loading on the adjacent intervertebral discs.

Prodisc C 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. In order to provide constraint, the prodisc mechanism of action enables movement with a fixed center of motion, enabling A/P translation only with flexion / extension.

In order to provide constraint, the prodisc mechanism of action enables movement with a fixed center of motion, enabling A/P translation only with flexion / extension.

Prodisc C Philosophy

MECHANISM OF ACTION

The pro disc 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.

M6 DISC

What is the M6-C™ artificial cervical disc?

The M6-C artificial cervical disc is a next-generation artificial disc developed to replace a vertebral disc damaged by cervical disc degeneration. The M6-C disc is designed to help restore motion to the spine and is an option for patients needing artificial disc replacement as an alternative to cervical fusion. By allowing your spine to move naturally, the M6-C artificial disc is designed to potentially minimize the stress to adjacent discs and other vertebral structures..

What else is unique about the M6-C artificial cervical disc?

The M6-C disc is the only disc designed with a shock-absorbing nucleus and fiber annulus that work together to replicate the controlled range of movement and cushioning effect of the natural disc. This unique product is designed to mimic your spine’s natural structure and movement, including backward and forward, side to side, up and down, and rotate left and right.

When did the M6-C artificial cervical disc receive approval?

Orthofix Medical Inc. announced U.S. Food and Drug Administration (FDA) approval of the M6-C artificial cervical disc for patients suffering from cervical disc degeneration in early February 2019. The M6-C disc received CE Mark approval for distribution in the European Union and other international geographies in 2006. There have been more than 45,000 implants of the M6-C disc outside of the U.S. to date.

 

Simplify Cervical Disc

What is the Simplify Cervical Disc?

The Simplify Cervical Disc is one of the newest cervical prosthetic discs to come to market in the USA.  It is part part of the NuVasive C360 portfolio. It has U.S. Food and Drug Administration (FDA) approval for one- and two-level cTDR, and is one of three devices approved for use in two-level cTDR procedures.

The device is designed with key performance functions, including:

Biologic material: The disc is uniquely comprised of polyetheretherketone (PEEK) on ceramic materials with no metal on articulating surfaces, low wear and nickel free. This composition helps optimize the disc’s biocompatibility.

Radiologic design: The materials of the disc allow for enhanced visualization postoperatively through MRI, a key imaging modality in spine.

Anatomic disc heights: The disc is anatomically designed and includes 4, 5 and 6 mm height options. The 4 mm disc, the lowest disc height in the market, closely matches the native disc height of a wide range of patients and was the most used height in the clinical trials.

Physiologic motion: The Simplify Artificial Disc design provides articulation which allows for a variable center of rotation for each treated level and is designed to closely mimic the motion dynamics of a natural spine segment.

What does the Simplify Cervical Disc help treat?

Like all cervical artificial discs, the Simplify Cervical Disc is used to treat a damaged or degenerated disc(s) in the cervical spine through the cTDR procedure. Artificial discs are designed to alleviate or reduce symptoms, such as pain, tingling, numbness, and/or weakness in the neck and arms, while maintaining a patient’s natural range of motion in the spine.

What is ACDF (anterior cervical discectomy and fusion)?

ACDF is a surgical procedure to treat the symptoms of cervical disc degeneration or nerve root or spinal cord compression. The surgeon decompresses the spinal cord or nerve root by removing a damaged vertebral disc, followed by fusing two or more vertebral bodies to stabilize the cervical anterior column. This may reduce motion at the treated segment and may lead to higher stresses on the adjacent anatomy which can lead to increased rates of secondary surgeries.

What is cTDR or ADR?

cTDR (total disc replacement) or ADR (artificial disc replacement) are abbreviations commonly used for the same procedure, that is a procedure used to treat the symptoms of cervical disc degeneration at one or two-levels, in eligible patients. In this procedure, the surgeon replaces a degenerated intervertebral disc(s) with an artificial cervical disc, like the Simplify Cervical Disc, which helps maintain a patient’s natural range of motion in the spine. With the goal of maintaining natural motion, cTDR or ADR provides comparable or favorable outcomes to ACDF.

Cervical TDR-ADR has a very high Neck Disability Index (NDI) success rate compared to ACDF – and motion is preserved!