Our very own Dr. Erik Bendiks performed the first 1-level M6-C ADR surgery in the state of GA.

What is cervical disc degeneration?


Cervical disc degeneration is a common condition that can cause pain in the neck, shoulders, arms and hands and lead to numbness and weakness in the arm or hands. Often this condition is the result of a vertebral disc that has deteriorated or been damaged due to the natural aging process or an injury. For many patients with cervical disc degeneration, spine surgeons have used the M6-C disc to replace the patient’s damaged disc with one that closely mimics their natural disc, enabling the patient to regain motion and return to their normal activities.


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.


M6 C Disc


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.


Results


Secondary outcomes at 24 months include:
Patients who received the M6-C disc demonstrated statistically significant improvement in the Neck Disability Index as measured at week six and months three, six, 12 and 24.
Meaningful clinical improvement was seen in the following pain scores:
– 91.2 percent of patients who received the M6-C disc reported an improvement in neck pain compared to 77.9 percent in patients who underwent the ACDF procedure.
– 90.5 percent of the M6-C patients reported improvement in arm pain scores compared to 79.9 percent in ACDF patients.


M6-C-Disc-with-Cutaway


Prior to surgery, 80.6 percent of the M6-C disc patients and 85.7 percent of the ACDF patients were taking some type of pain medication for the treatment of their cervical spine condition. At 24 months, the rate of M6-C patients who were still taking some type of pain medication dropped to 14.0 percent compared to 38.2 percent of the ACDF patients.
Of these, there was a seven times higher rate of opioid use with the ACDF patients than with patients who received the M6-C disc.
– There was a statistically significant difference in the average mean surgery time – 74.5 minutes for patients receiving the M6-C disc versus 120.2 minutes for those patients having the ACDF procedure.
– In addition, there was a statistically significant difference in the mean length of hospital stay – 0.61 days for the M6-C patients versus 1.10 days for ACDF patients.
– Subsequent surgery at the treated level was needed in 4.8 percent of the ACDF patients compared to 1.9 percent of the M6-C disc patients.
– There were no device migrations reported in the study.
– Overall patients receiving the M6-C disc reported a 92-percent satisfaction rate with the surgery,
and 93 percent said they would have the surgery again.
– There were 3.8 percent serious adverse events related to the device or procedure in the M6-C
disc group versus 6.1 percent in the ACDF group.


The M6-C disc received U.S. Food and Drug Administration (FDA) approval in February 2019 based on the results of this study.

Security policy

GEORGIA SPINE AND ORTHOPAEDICS

PRIVACY NOTICE

THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION.   PLEASE REVIEW IT CAREFULLY.

This Privacy Notice is being provided to you as a requirement of a federal law, the Health Insurance Portability and Accountability Act (HIPAA). This Privacy Notice describes how we may use and disclose your protected health information to carry out treatment, payment or health care operations and for other purposes that are permitted or required by law.  It also describes your rights to access and control your protected health information in some cases. Your “protected health information” means any written and oral health information about you, including demographic data that can be used to identify you. This is health information that is created or received by your health care provider, and that relates to your past, present or future physical or mental health or condition.I. Uses and Disclosures of Protected Health Information

1. Uses and Disclosures of Protected Health Information The Organizations may use your protected health information for purposes of providing treatment, obtaining payment for treatment, and conducting health care operations.  Your protected health information may be used or disclosed only for these purposes unless the facility has obtained your authorization, or the use or disclosure is otherwise permitted by the HIPAA privacy regulations or state law.  Disclosures of your protected health information for the purposes described in this Privacy Notice may be made in writing, orally, or by facsimile.

II. Uses and Disclosures beyond Treatment, Payment and Health Care Operations Permitted without Authorization or Opportunity to Object

Federal privacy rules allow us to use or disclose your protected health information without your permission or authorization for several reasons including the following:

The facility may release your health information to comply with worker’s compensation laws or similar programs.

III. USES AND DISCLOSURES PERMITTED WITHOUT AUTHORIZATIONS BUT WITH OPPORUTNITY TO OBJECT

We may disclose your protected health information to your family member if it is directly relevant to the person’s involvement in your care or payment related to your care.  We can also disclose your information in connection with trying to locate or notify family members or others involved in your care concerning your location, condition or death.

You may object to these disclosures. If you do not object to these disclosures, in the exercise of our professional judgment, that it is in your best interest for us to make disclosure of information that is directly relevant to that person’s involvement with your care, we may disclose your protected health information as described.

IV. USES AND DISCLOSURES WHICH YOU AUTHORIZE

Other than stated above, we will not disclose your health information other than with your written authorization.  You may revoke your authorization in writing at any time except to the extent that we have acted in reliance upon the authorization.  We specifically require your written authorization for marketing or the sale of your protected health information. If our facility maintains psychotherapy notes, we will require your written authorization for the use or disclosure of psychotherapy notes other than by the creator of those notes, by the facility for its training programs or for the facility to defend itself in a legal action brought by you.

V. YOUR RIGHTS
You have the following rights regarding your health information:

 

VI. OUR DUTIES

The facility is required by law to maintain the privacy or your health information and report to you any breach of unsecured protected health information.  We are also required to provide you with this Privacy Notice of our duties and privacy practices. We are required to abide by terms of this Notice as may be amended from time to time. We reserve the right to change the terms of this Notice and to make the new Notice provisions effective for all future protected health information that we maintain.  If the facility changes this Notice, we will post notification at each office location and provide a copy of the revised Notice on our website.

VII. COMPLIANTS

You have the right to express complaints to the facility and to the Secretary of Health and Human Services if you believe that your privacy rights have been violated.  You may complain to the facility by contacting the Privacy Officer verbally or in writing, using the contact information below. We encourage you to express any concerns you may have regarding the privacy of your information. You will not be retaliated against in any way for filing a complaint.

VIII. CONTACT PERSON

The facility’s contact person for all issues regarding patient privacy and your rights under the federal privacy standards is the Privacy Officer.  Information regarding matters covered by this Notice can be requested by contacting the Privacy Officer. If you feel that your privacy rights have been violated by this facility you may submit a complaint to:

Georgia Spine & Orthopaedics

Attn: Privacy Officer

11650 Alpharetta Hwy, Suite 100,

Roswell, GA 30076

Phone: 404-596-5670

 

Anonymous HIPAA Hotline: 844-333-0850

 

If you are unable to get your issue resolved, you may file a complaint with the U.S. Department of Health and Human Services Office for Civil Rights by sending a letter to 200 Independence Avenue, S.W., Washington, D.C. 20201, or by calling 1-877-696-6775.

 

Last Revised:9/19

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