Surgery With Synergy Disc

Artificial Disc Replacement Surgery with the Synergy Disc^®

The Synergy Disc is a cervical artificial disc used in disc replacement surgery. The Synergy Disc is used in patients with cervical degenerative disc disease in one disc space.

The Synergy Disc is made of two titanium alloy endplates that sandwich a plastic core made of ultra-high molecular weight polyethylene, which is a very dense, commonly used medical-grade plastic material. The endplates and core move together to restore motion in the cervical spine.

The outside of both the top and bottom endplates are coated with a titanium spray that helps bone attach and grow onto the endplates. Along with the coating, the fins on the top and bottom endplates anchor the Synergy Disc to the bone above and below the disc space.

The Synergy Disc is available in different sizes so your surgeon can choose the best size to fit your disc space. After a damaged disc is removed, the surgeon measures the space where the damaged disc was, and the surgeon picks the size that fits best in that space. The Synergy Disc is made to match the shape of the disc space, so it fits properly between the bones of the spine to help restore natural motion and alignment.

Who Is A Candidate for Artificial Disc Replacement Surgery with the Synergy Disc?

A candidate for the Synergy Disc, a cervical artificial disc replacement device, is a patient with degenerative disc disease who is suffering from serious neck pain, arm pain, numbness, or weakness caused by a damaged disc in the neck.

Surgeons will usually recommend trying other conservative treatments before recommending surgery. Conservative treatments include anti-inflammatory medications, physical therapy, or injections. After some time, if these conservative treatments don’t help relieve the pain or symptoms that are affecting daily life, artificial disc replacement surgery may be considered.

This type of surgery is usually best for someone who is in good overall health, has one damaged disc, and wants to keep normal neck movement after surgery. A cervical spine surgeon will review the patient’s symptoms, health history, and imaging tests (like an MRI) to decide if artificial disc replacement is the right option.

Please talk to a cervical spine surgeon to learn more about artificial disc replacement surgery, its benefits, and risks. After reviewing your health history, performing an exam, and reviewing X-ray images, an experienced cervical spine surgeon will decide if you are a candidate for this surgery.

What are the Indications for the Synergy Disc?

The Synergy Disc is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. The Synergy Disc is implanted using an anterior approach.

Patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite non-operative treatment before implantation of the Synergy Disc.

Who Should Not Receive a Synergy Artificial Disc Replacement (Contraindications)?

Not every person with neck or arm pain is a candidate for cervical artificial disc replacement surgery. This surgery may not be a good choice for a patient who has more than one diseased or damaged disc, or bones that are not healthy enough or too mobile to support an artificial disc.

Contraindications to the Synergy Disc include, but are not limited to:

Tumor or trauma
Intractable radiculopathy or myelopathy necessitating surgical treatment at more than one cervical level
Allergy or sensitivity to the implant materials (e.g. titanium and polyethylene)
Bridging osteophytes
Radiographic instability on lateral, coronal, or flexion/extension radiographs
Facet disease or degeneration
Active systemic infection or local infection
Osteoporosis is defined as Dual-Energy X-ray Absorptiometry (DEXA) bone mineral density T-score less than -2.5
Advanced cervical spine conditions or diseases at the index level other those included in the
Indications for Use (e.g., rheumatoid arthritis, (diffuse idiopathic skeletal hyperostosis (DISH), ankylosing spondylitis).

The expected clinical benefits of cervical disc replacement devices, such as the Synergy Disc implant, when used according to instructions for use and recommended technique, are to restore motion and balance to the intervertebral disc, resulting in a reduction in pain and disability (clinical improvement in function).

What are the Warnings for the Synergy Disc?

The Synergy Disc should be used by experienced cervical spine surgeons after receiving individualized training on the use of the Synergy Disc.

Proper selection of implant size, including lordotic angle, and positioning of the Synergy Disc is critical to making sure the Synergy Disc works as expected. Information about correct implant size selection and placement is provided to your doctor.

Due to the closeness to vascular and neurological structures to the implantation site, there are risks of serious or fatal bleeding. There is also a risk of neurological damage or injury to nearby organs. Care must be taken to protect these critical areas.

There is a risk of extra bone growth with all artificial disc replacement implants. This could lead to reduced neck motion or fusion at the treated spinal level or at spinal levels next to the implant.

Exercise care not to damage the implant (articulation surfaces) during installation. The Synergy Disc Implant and a Synergy Disc Instrument System (consisting of the instruments and trials) should be used together for proper implantation.

The Synergy Disc Implant is single patient use only. Do not resterilize or reuse the Synergy Disc. Resterilization and/or reusing the Synergy Disc may result in impaired performance and could cause patient injury and/or the transmission of infectious diseases between patients.

What are the Precautions Associated with the Synergy Disc?

Below is a list of precautions to be aware of as the safety and effectiveness of the Synergy Disc has not been established in patients with the following conditions:

Over the age of 70
Previous spine surgery at the level of the currently requiring surgery (other than nominal removal of part of the vertebral bone with spine joints intact)
Only symptom is soreness of the neck muscles
Very limited motion of the level requiring surgery
Diseases which affect bone development or mineral levels
Autoimmune diseases
Insulin-dependent diabetes
Current or extended use (more than 6 months) of any drug that may interfere with bone or soft tissue healing

What are the Potential Risks and Adverse Events Associated with This Type of Surgery?

All surgical procedures carry risks and potential adverse events. Below is a partial list of risks, not a complete list, which may occur in any surgical procedure, with anterior interbody surgeries, and with the Synergy Disc and other disc replacement procedures. Please ask your cervical spine surgeon to explain any risks involved in the surgery in greater detail if you have questions.

Risks associated with any surgical procedure include, but are not limited to:

Wound infection, cellulitis, abscess
Wound dehiscence/reopening
Adverse reactions to anesthesia
Pulmonary complications, embolism, pulmonary embolism, thromboembolism
Hemorrhage
Death

Risks associated with anterior interbody surgery of the cervical spine include, but are not limited to:

Difficulty swallowing (dysphasia), or speaking (dysphonia)
Nerve deficits or damage
Hoarseness, sore throat, or vocal cord paralysis
Spinal cord, nerve, or nerve root damage, possibly resulting in paralysis or pain, or dural tear, or leaking
Loss of disc height, loss of proper curvature, correction, height, or reduction of the spine
Herniation or degeneration of adjacent discs

Risks associated with any implants in the spine, including the Synergy Disc implant, include, but are not limited to:

Early or late loosening of the components, disassembly, bending, or breakage of any or all of the components
Implant migration
Implant fracture
Foreign body reactions to the implant, including allergic reactions
Infection development of new radiculopathy, myelopathy, or pain
Persistent pain
Bone overgrowth, termed heterotopic ossification (HO)

Synergy Cervical Disc U.S. Clinical Trial

The Synergy Disc system was evaluated in a clinical trial conducted in the United States. It was studied for the safe and effective treatment of cervical degenerative disc disease in people with one-level cervical degenerative disc disease. Patients in the trial had disc disease that caused problems with nerve function due to pressure on the nerve roots and/or the spinal cord.

The clinical trial enrolled 175 patients who were implanted with the Synergy Disc and followed for at least 24 months. The patients with the Synergy Disc were compared with 184 similar “control” patients who received an anterior discectomy and fusion (ACDF) in a previous clinical trial.

The control group had the standard ACDF procedure using an anterior approach (from the front of the neck) followed by the removal of the diseased disc. The empty disc space was filled with allograft (a type of tissue), and anterior plates were placed as is standard for the ACDF procedure.

Patients in the Synergy Disc study had to be between 18 and 70 years of age, have symptoms of either radiculopathy or myelopathy at only one cervical level, and have failed 6 weeks of conservative care. Osteoporotic patients, patients with other diseases that affect the musculoskeletal system or who were taking medications that interfere with bone/soft tissue healing, and those with a body mass index of more than 40 were excluded from the study. Patients who had a prior ACDF surgery at a different, single cervical (neck) level were allowed in the study.

The clinical benefits of the Synergy Disc system are briefly summarized below; these results include some of the benefits as well as the adverse effects from the Synergy Disc clinical trial through 24 months.

Two years after surgery, 87.1% of patients who received the Synergy Disc and completed the study achieved overall study success compared to 56.6% of the control ACDF patients. Patients were counted as a success only if they met all of the following criteria: at least 15-point improvement in the Neck Disability Index, maintenance or improvement in neurological status, no study failure due to secondary surgical interventions (e.g. surgery at the same disc space as the implant), no device-related serious adverse event, and no evidence of radiographic failure.

Other key results from the study at 24 months after surgery include:

There were 5 device-related serious adverse events (SAE) in 2.8% (5/177) of the Synergy Disc patients, which was less than the 21 device-related SAEs reported in 10.9% (21/192) of the ACDF patients.
There were 6 procedure-related SAEs in 3.4% (6/177) of the Synergy Disc patients, which was less than the 23 procedure-related SAEs reported in 12.0% (23/192) of the ACDF patients.
Another surgery at the treated disc space was needed in 4 of the Synergy Disc patients, compared to 8 of the ACDF patients.
At two-years, 91.7% (143/156) of the Synergy Disc patients achieved a meaningful improvement (greater than 15-point change) on the Neck Disability Index (NDI), compared to 75.2% (112/149) of ACDF patients.
NDI is an outcome measure designed to evaluate a patient’s neck function.
At two-years, 83.9% (130/155) of Synergy Disc patients achieved a greater than 20-point improvement in VAS – Neck Pain score compared to 75.33% (113/150) of ACDF patients.
At two-years, in response to the question, “How satisfied are you with your treatment?,” 84.5% (131/155) of the Synergy Disc patients responded, “Very Satisfied,” compared to 61.6% (93/151) of ACDF patients.

The clinical benefit of the Synergy Disc system has not been studied beyond two years. Your cervical spine surgeon can give you more information about this clinical trial and the results.

What are the Expected Outcomes and Benefits of the Synergy Disc?

For patients who are Synergy Disc candidates, this surgery offers an additional option of treatment. It may help stop, or reduce, the pain and tingling in your arms and other problems caused by a damaged cervical disc.

Artificial cervical disc replacement with the Synergy Disc should relieve symptoms of nerve root or spinal cord compression caused by degenerative disc disease. Additionally, it may:

Minimize pain in your back and/or arms
Minimize tingling in your arms
Help your neck move more naturally and in all directions
Help you return to your normal activities of work, family, and recreation.

Preparation for Cervical Artificial Disc Replacement Spine Surgery

Before cervical artificial disc replacement surgery, your surgeon will discuss the procedure with you, including what to expect before and after the surgery. It is important to follow their guidance and instructions and ask questions when you don’t understand what is being said.

Before surgery, they may discuss the following:

Available treatment options, along with the benefits and risks of each
Your current medications and which ones you may need to stop taking before surgery
Instructions on what to do the night before the surgery, including when you should stop eating and drinking.
Review any medications and items that you may need at home after surgery
Answer any questions you may have about the surgery and recovery.

What Happens During Cervical Artificial Disc Replacement Surgery with the Synergy Disc?

During cervical artificial disc replacement surgery, a spine surgeon removes the diseased or damaged disc and replaces it with an artificial disc. The steps of the procedure include the cervical spine surgeon:

Making a small incision across the front of the neck and gently moving aside the muscles and soft tissue
Removing the worn-out spinal disc and osteophytes/bone spurs so that the space where the disc was is prepared for the new cervical artificial disc
Measuring for the best artificial disc size
Placing the new artificial disc into the disc space
Taking a few X-ray pictures to ensure the Synergy Disc is placed correctly
The incision in the neck is closed with stitches when the surgeon is sure the Synergy Disc is properly placed

What Happens After Cervical Disc Replacement Surgery with the Synergy Disc?

Cervical artificial disc replacement surgery is considered a major surgery. After the surgery is complete, you will stay in the recovery room for several hours before being moved either to a hospital room or being discharged home. Patients undergoing this type of surgery are typically discharged within a day of surgery.

A nurse will review the discharge instructions with you. It is important to follow these instructions to ensure a complete recovery.

The following topics are important to discuss in the post-operative recovery discussion with your surgeon or nurse.

Expectations for recovery
At-home wound care instructions
Timing of when to take a shower or bath
Movements or activities that should be avoided
Timeline of when to start activities
Post-operative medications
Physical therapy recommendations
Follow-up appointments
When to call if there is a problem after surgery

It is important to contact your surgeon if you are in severe pain or discomfort following surgery. Some pain is expected, but extreme pain is not. After surgery, if you are experiencing any of the following symptoms, please call your surgeon immediately.

Neck or arm pain, weakness, or numbness is increased or new
The incision feels warm, looks red, or is very painful
There is fluid leaking from the incision
You have a fever or trouble breathing or swallowing

Frequently-Asked Questions

Will I have a scar after the surgery?

Yes, a small scar (about 1 inch) may be visible on the front of your neck, but the scar usually fades over time.

What if my surgery doesn’t work?

If you continue to experience pain, or you experience new pain in your neck and/or arms, call your surgeon immediately so he can assess the effectiveness of the surgery. Your surgeon will discuss your problems with you and may suggest different treatment options.

How often do I have to see my doctor after my surgery?

Typically, your surgeon will see you shortly after your surgery, then again at 6 weeks, and then on a recurring schedule, they will discuss with you. It is important to come in for these appointments so the surgeon can be certain the implant is functioning as it was designed.

Can I return to exercise or sports after surgery?

Your surgeon will discuss your recovery with you and let you know when it is okay to return to exercise and sports. Many patients do return to their activities after surgery.

Can I have an MRI after surgery with the Synergy Disc?

Yes. The Synergy Disc is MRI-compatible. However, MRI machines can vary. Please consult your surgeon before any MRI study.

Will the Synergy Cervical Disc last forever?

The Synergy Disc is designed to last for the life of the patient; however, everyone is different, and follow-up visits are important to make sure the Synergy Disc is continuing to work well.