Degeneration of the cervical disc occurs as we age. Injury, daily wear and tear, and genetics also contribute to this process. Degeneration consists of damage to the cervical disc, which may then become narrowed or may herniate. This causes symptoms of pain, numbness, tingling, and/or weakness in the arms or shoulders, and may also cause neck pain. The available treatments are directed at these symptoms and do not represent a cure for the degenerative process.
The following provides an overview of standard, non-surgical and surgical treatments for cervical disc degeneration.
If cervical disc degeneration is established as a diagnosis, your doctor will likely recommend one or more of the following treatments:
Your doctor can discuss recommended treatment options based on your individual needs.
Cervical spine surgery for pain and other symptoms of cervical disc degeneration or herniation begins by making an incision in the neck, once anesthesia has been administered. During surgery, the surgeon will access the cervical spine from the front of your neck, and will remove the damaged disc and any tissue that is compressing the spinal cord and/or nerves. After removing the disc, the surgeon will implant a device to help stabilize the joint. Anterior cervical discectomy and fusion (ACDF) and cervical disc replacement procedures are comparable in their surgical approach and length of surgery time.
ACDF is the current standard of care for cervical disc disease. Fusion surgery consists of removing the damaged disc. After the disc is removed, bone graft (bone taken from another area) or a synthetic spacer is placed into the disc space and a cervical plate with screws is used for stabilization. The goal of this procedure is to permanently fuse two or more vertebrae together so they do not move except as a single unit. This procedure may alleviate the pain and other symptoms of cervical disc disease. While an ACDF usually relieves pain and other symptoms, it does result in loss of motion in the fused joints.
An alternative procedure to an ACDF is a cervical disc replacement surgery, which aims to stabilize the spine allowing motion to occur at the joint instead of fusing the vertebrae together. For that reason, artificial cervical disc replacement devices such as the NuVasive® PCM® Cervical Disc have been developed.
The PCM® Cervical Disc is designed to replace the diseased disc, providing support for the vertebrae while allowing for movement of the joint. The PCM Cervical Disc consists of the following parts: an upper metal (cobalt chromium molybdenum alloy) endplate, and a lower metal endplate to which a plastic (polyethylene) spacer is attached. These materials are the same as the ones used for most spinal and orthopedic devices. Several device sizes are available to best fit the disc space.
The PCM® Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-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 disc space and manifested by 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 as compared to adjacent levels. The PCM Cervical Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the PCM Cervical Disc.
The clinical study was limited to patients that met certain criteria, therefore the safety and effectiveness of the PCM® device has not been established in patients with the following conditions:
The PCM Cervical Disc has not been evaluated for safety and compatibility in the MRI environment. The PCM Cervical Disc has not been tested for heating or migration in the MRI environment.
As with any surgery, there are some possible serious risks that can occur when receiving the PCM Cervical Disc. Potential risks associated with the use of the PCM Cervical Disc include: 1) those commonly associated with any surgery; 2) those specifically associated with cervical spinal surgery using an anterior approach; and 3) those associated with a spinal implant, as well as those pertaining to the PCM Cervical Disc. However, the causality of these adverse events is not exclusive to these categories. Some of the following effects were observed in the clinical study.
It is also possible that the surgery will not reduce or relieve your symptoms, and that treatment may not result in therapeutic or direct health benefits or may cause worsening of preoperative symptoms. Promptly notify your surgeon if the preoperative symptoms fail to improve or worsen, or new symptoms develop. This cannot be predicted for either the PCM implant or fusion surgery. If the implant does not relieve symptoms or if there is a problem with the device, it is usually possible to have it removed. This would require another surgery.
In the U.S. clinical study of 214 patients who received the PCM® Cervical Disc, the most commonly or clinically significant reported device or surgery related adverse events included neck and arm pain 9.8% (21 patients), dysphagia/dysphonia 6.5% (14 patients), incision site complications 5.6% (12 patients), neurologic 5.6% (12 patients), spinal events 5.6% (12 patients), and implant loosening or dislodgement 4.7% (10 patients). In addition, 6.1% (13 patients) required removal of the PCM device and 1.4% (3 patients) required reoperations. There may be other risks associated with using the PCM Cervical Disc. Of the 190 patients who underwent ACDF, the most commonly reported device or surgery related adverse events included neck/arm pain 17.4% (33 patients), adjacent level disease 14.2% (27 patients), dysphagia/dysphonia 12.1% (23 patients), spinal events 6.3% (12 patients), nonunion 5.8% (11 patients), and neurologic 5.3% (10 patients). Although many of the major risks are listed here and in the patient information brochure, more comprehensive safety information is provided in the physician’s package insert for the product. Please ask your doctor for more information and an explanation of these risks.
If the PCM Cervical Disc procedure is a success, it may result in the relief of symptoms such as decreased neck/arm pain. In addition, the joint may retain some degree of motion. The PCM Cervical Disc may allow patients to preserve cervical motion at the level of surgery, including axial rotation (turning your neck), lateral bending (side-to-side bending), and flexion-extension (nodding up or down). This may allow you to return to many of your normal activities.
Your doctor will review your condition and explain all of your treatment options, including medications, physical therapy, and other surgeries such as removal of the diseased disc, fusion, etc. Your doctor may also speak with you about preparations that you should make at your home, arranging for assistance, and the risks and benefits of this procedure. Please ensure that you have read and that you understand this entire brochure.
During the PCM® Cervical Disc surgery, you will be under general anesthesia. The surgeon will access your spine from the front of your neck, and will remove the damaged disc and any tissue or obstructions that are compressing the nerves or spinal cord. After shaping the edges of the vertebrae to ensure a proper fit, the PCM Cervical Disc is inserted. The surgery lasts approximately one-to-two hours and most patients leave the hospital the following day.
Treatment with the PCM Cervical Disc is major surgery. As with any major surgery, you should expect some discomfort as well as a period of rehabilitation. Your doctor may prescribe medications to manage any pain or nausea you might experience. On average, you should expect to stay in the hospital for one or two days.
You and your doctor should discuss your recovery plan while the healing process takes place. It is very important to follow your doctor’s instructions. Your doctor may give you the following instructions:
Your doctor will instruct you on how to limit postoperative activity to reduce the risk of adverse events. The use of a cervical collar may be prescribed, depending on the doctor’s assessment of your activity level and overall condition. Generally, at one day postoperatively, you may start physical therapy but, non-impact exercises are preferred. Generally, at 3 weeks postoperative, you may do Pilates or light weight training with a 40lb weight-lifting restriction. Generally, after the 6 week visit, you may be unrestricted with regard to weight training provided radiographs demonstrate good alignment. Repetitive cervical flexion and extension bending or the extremes of lateral bending and rotation should be avoided for 6 weeks postoperatively. Remember to consult with your doctor before performing any of these activities.
Depending on your surgical incision, you may have showering restrictions. Ask your doctor for appropriate instructions.
The surgical incision is usually about one inch long and usually heals so that it is barely visible. Ask your doctor for more information as every patient is different.
For a period of time after your surgery, you may be cautioned about activities such as driving. Your doctor will tell you when you may drive again.
The PCM Cervical Disc may interfere with metal detection devices depending on the sensitivity of the equipment. Because of increased airport security measures, please call your local airport authority before traveling to get information that might help you pass through security more quickly and easily. Ask your surgeon to provide a patient identification card.
If you have any questions about the PCM Cervical Disc or cervical spine surgery, please call or see your doctor, who is the only one qualified to diagnose and treat your spinal condition. This patient information is not a replacement for professional medical advice.
The PCM® Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate. A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.
Patients were evaluated before surgery, during the operation, immediately after surgery, and then at 6 weeks, 3 months, 6 months, 12 months and 24 months, and yearly after surgery. The patients were recommended to have a physical therapy program for non-impact exercises and active range of motion exercises after surgery. Patients were also instructed to avoid repetitive cervical flexion and extension bending and lateral bending and rotation for 6 weeks following surgery.
The safety of the PCM Cervical Disc was assessed by comparing the adverse events, any additional surgical procedures, and the neurological outcomes to those in the ACDF control group. The effectiveness of the PCM Cervical Disc was assessed by evaluating patients’ pain and function outcomes using a standard questionnaire, the Neck Disability Index (NDI), the severity of neck and arm pain based on a Visual Analog Scale (VAS) assessment, quality of life using a standard questionnaire, the Short Form-36 (SF-36), as well as a patient satisfaction questionnaire compared to the ACDF control group.
In addition, the patients were evaluated using radiographic evaluations, including spinal range of motion, spinal disc height, device displacement or migration, spinal fusion status, and heterotopic ossification (abnormal bone formation).
In the study, the average patient age was 45-years-old and 52% of the patients were men. Before surgery, approximately 80% of patients had symptoms of radiculopathy (a pathologic condition of the nerve roots) and approximately 19% had both radiculopathy and myelopathy (a disease or disorder of the spinal cord) symptoms.
The primary endpoint of the IDE trial was a composite measure termed “overall success,” which was evaluated at 24 months postoperatively, and was defined as at least 20% improvement in neck disability index (NDI) from preoperative score; absence of reoperation, revision, or removal; maintenance or improvement in neurological status; and absence of radiographic or major complications during the 24-month follow-up period. At the 24 months, overall success was achieved by 75.1% of the PCM patients compared to 64.9% of the ACDF patients.
In the U.S. clinical study of 214 patients who received the PCM Cervical Disc, the most commonly reported device or surgery related adverse events included neck and arm pain 2.3% (5 patients), incision site complications 5.6% (12 patients), dysphagia/dysphonia 5.1% (11 patients), and implant loosening or dislodgement 2.3% (5 patients). In addition, 6.0% (13 patients) required removal of the PCM device and 1.4% (3 patients) required reoperations. There may be other risks associated with using the PCM Cervical Disc. Of the 190 patients that were treated with ACDF, the most commonly reported device or surgery related adverse events included neck/arm pain 16.8% (32 patients), adjacent level disease 14.2% (27 patients), dysphagia/dysphonia 12.1% (23 patients), nonunion 5.8% (11 patients), and neurologic 5.3% (10 patients). Although many of the major risks are listed in this patient information webpage, more comprehensive safety information is provided in the physician’s package insert for the product. Please ask your doctor for more information and an explanation of these risks.
Complete information will be available in the PCM PMA Summary of Safety and Effectiveness Data (P100012) at www.fda.gov.
The growing body of evidence supports the fact that in well-selected patients, cervical arthroplasty is at least as successful (defined in several clinically meaningful ways) as the “gold standard” treatment of ACDF and may indeed offer advantages. Historic FDA-approved randomized, multicenter IDE clinical trials comparing cervical arthroplasty to ACDF were designed as non-inferiority clinical trials. These trials, conducted with the goal of FDA product approval, used more stringent success criteria than the historical ACDF studies and yet each individually showed at least non-inferiority of cervical arthroplasty compared with fusion. However, individually, the trials were not statistically powered to demonstrate a statistically significant improvement in clinical outcomes or “superiority” of one procedure over the other. A recently published paper using a meta-analysis was performed to pool the data from four approved cervical arthroplasty devices, including the PCM Cervical Disc, in an attempt to improve the statistical strength of the analysis.¹ The results of this meta-analysis suggest that for the common indications studied (1-level cervical disc degeneration with radiculopathy and/or myelopathy), cervical arthroplasty is not statistically different from ACDF in NDI success (15-point improvement from baseline) but is statistically superior to ACDF in the overall success (a composite risk-benefit endpoint), neurological success (maintenance of improvement neurological status from baseline) and survivorship (absence of revisions) outcomes 24 months postoperatively.
Read the full, published meta-analysis paper in Spine by clicking below.