 |
|
|
Physiatrists Surgeons |
CINN
has specialists available to evaluate job requirements and susceptibility
to back injuries. If you are interested in this service, please contact
Lisa Dombro at ldombro@cinn.org
Editor’s MessageThe Discussant before you represents our commitment to providing you and your patients, clients or employees with the latest news on pivotal advancements in the treatment of spine disorders. As patients age, degenerative conditions of the cervical spine can cause debilitating pain in the neck and arm, as well as numbness and weakness in the hands and legs. In fact, neck pain accounts for almost one percent of all visits to a primary care physician in the United States. In this issue, we provide a preview of artificial cervical discs, a new option to treat radicular and myelopathic pain associated with degenerative disc disease in the neck. While results of the pivotal IDE study have not yet been released, a recent study did show that patients implanted with a cervical artificial disc returned to work in fewer days, compared to those receiving cervical fusion. We anticipate that the FDA will approve the first cervical disc in early 2007. Similar to CINN’s leadership role in lumbar disc arthroplasty, neurosurgeon, Dean Karahalios, M.D. and I have been selected to be two of three physicians in Chicagoland that will train other interested surgeons. As such, CINN will be one of the first to offer this exciting new option for patients. In this issue we also look at surgical options for treating intractable or chronic pain. Studies show that pain is the chief complaint in 40 percent of primary care visits. Persistent chronic pain is reported in 20 percent of these visits. Dr. Sami Rosenblatt, neurosurgeon, reports on the efficacy of two modalities – implantable neurostimulators and implantable drug delivery systems (IDDS) – typically reserved for patients with debilitating chronic pain that has stopped responding to medical management, and for those with chronic pain that has not subsided with surgical intervention. Members of our team are consistently developing and implementing advancements in spine care. This means you and your patients, clients or employees benefit from our advanced knowledge of better treatment options. Noam
Y. Stadlan, M.D. |
|
|
FDA Approval for the First Cervical Artificial Disc is Expected in Early 2007
 |
Cervical arthroplasty after anterior cervical decompression at one or more levels is another exciting tool in the management of degenerative disc disease. Used extensively in Europe, the first cervical artificial disc, the Prestige‚ Cervical Disc System, from Medtronic, has received a unanimous recommendation for approval from the United State’s Food and Drug Administration’s (FDA) Orthopedic and Rehabilitation Devices advisory panel. Typically the FDA follows the advisory board’s recommendations.
Artificial cervical discs are indicated in patients with cervical degenerative disc disease (DDD). Cervical DDD is defined as intractable radiculopathy and/or myelopathy with symptomatic nerve root and/or spinal cord compression which is documented by patient history and radiographic studies.
Currently, more than 200,000 cervical procedures are performed each year to relieve compression on the spinal cord or nerve root and to implant a metal plate to rigidly fuse the vertebrae together. The theoretic advantages of a cervical artificial disc include the benefits of conventional decompression and fusion. In addition, there is the promise of preservation of motion and the elimination of adjacent level degeneration which may be a problem leading to further surgery in patients undergoing conventional fusion procedures.
Studies show artificial cervical disc replacement is a satisfactory management option for the treatment of degenerative disc disease after anterior cervical decompression, with good medium term results. Low morbidity combined with an excellent postoperative outcome and avoidance of the known problems associated with cervical arthrodesis or allograft/autograft usage indicates that this procedure may play an important role in the management of spondylotic cervical disease.
As one example of the clinical studies recently completed or underway, the Prestige Cervical Disc System underwent a prospective, multi-centered randomized clinical trial to assess the safety and effectiveness based on comparisons between data collected from skeletally mature patients with single level symptomatic cervical DDD at one level between C3-C7. The investigational group of 276 patients was implanted with the artificial disc while the control group of 265 patients received an anterior plated surgical fusion utilizing bone graft and plate stabilization.
For more information regarding cervical disc arthroplasty, please contact Noam Stadlan, M.D. or Dean Karahalios, M.D. at 773/250-0500.
Return to Work Analysis of Patients Treated with an Artificial Cervical Disc or an Athrodesis
INTRODUCTION
Return to work data provides valuable information concerning the efficacy of a treatment from a medical and economical perspective. Return to work data was assessed for patients enrolled in both the Bryan and Prestige Cervical Disc IDE studies.
METHODS
Patients from the Bryan and Prestige IDE studies were examined separately to maintain statistical integrity. Both IDE studies prospectively followed patients with single-level symptomatic cervical spinal disease who were randomly assigned to receive either an instrumented ACDF or a cervical disc replacement. The return to work data was analyzed for both treatment groups.
RESULTS
The Bryan data included 240 patients Bryan discs and 222 patients with an arthrodesis. The median returns to work (days) for the Bryan patients were 50 and for the controls it was 74. There was no statistical difference in the demographics or preoperative status between the treatment groups, however the difference in median return to work time was statistically significant.
The Prestige data consisted of 250 patients who received a Prestige disc and 260 individuals who were treated with an arthrodesis. There was no statistical difference in the demographics or preoperative status between treatment groups. Patients receiving the Prestige device had an overall median return to work of 46 days, which was significantly different than the median return to work time for patients receiving an arthrodesis, which was 63 days.
CONCLUSION
Patients treated with an artificial cervical disc return to work more rapidly than those treated with an arthrodesis and the difference between the two is statistically significant.
Vincent Traynelis, M.D.; Abstract presented at the Congress of Neurosurgeons and American Association of Neurological Surgeons annual meetings, 2006
Surgical Options for Chronic Pain Management
One in three Americans suffer with some form of chronic pain. In fact, chronic pain has been estimated to cost the American society approximately $120 billion a year in treatment, lost revenues, and wages. The annual estimated total cost for back pain itself, including disability and litigation, is more than $100 billion. Studies show that pain is the chief complaint in 40% of primary care visits. Of these visits, persistent chronic pain is reported in 20%. A sample of primary care practices identified that chronic pain required pain medications and treatment in 14% of patients, and 6% of patients reported high levels of disability because of pain.
There is a subset of this patient population for which conventional pain management therapies may not be effective, or fail over time and require more invasive approaches. Two modalities – implantable neurostimulators and implantable drug delivery systems (IDDS) – are considered safe and effective alternatives for patients with very difficult pain issues. Etiologies demonstrating efficacy include complex regional pain syndrome (CRPS), failed back syndrome (FBSS), peripheral vascular disease (PVD), angina, metastatic disease, lower limb pain caused by multiple sclerosis (MS), and spasticity resulting from MS, spinal cord injury, cerebral palsy (CP), brain injury, and stroke.
Spinal Cord Stimulation
 |
In recent years, SCS has been applied with increasing effectiveness because of improved patient selection criteria, improved accuracy in electrode placement, and improvements made to the multipolar and multichannel devices.
“Spinal cord stimulation attempts to effectively block out the pain signal,” says Dr. Sami Rosenblatt. This approach is ideal for patients with unilateral neuropathic extremity pain, which in general does not respond to narcotics. Such patients tend to describe a burning type of pain.” Dr. Rosenblatt explains.
Results of a 22-year study by Krishna Kumar, M.D. and colleagues suggest SCS can provide significant long-term pain relief with improved quality of life and employment. The team studied 410 patients, all of whom had used narcotic medications for pain control and were gated through a multidisciplinary pain clinic where they received conventional pain management that eventually failed to provide adequate pain control. At that point, the patients were referred for consideration of SCS therapy. All patients who were considered suitable candidates for SCS initially underwent a trial period of stimulation for four to seven days to ascertain their response to stimulation. Only those patients who achieved 50 percent or greater pain relief on trial stimulation had their systems internalized.
Kumar, et al. reported that with trial stimulation, 80% of the patients studied experienced greater than 50% pain relief according to visual analog scale (VAS) and subsequently had their systems internalized. Eighty-two (20%) patients who failed trial stimulation were classified as early failures. At the mean follow-up period of 97.6 months, 243 (74%) of the patients with internalized systems continued to receive satisfactory pain relief. Eighty-five patients were thus considered late failures (post-internalization) because of progressive loss of effective pain relief on follow-up. Among the 243 patients receiving long-term, satisfactory pain relief, 62 (25.5%) reported excellent results (>75% pain relief), whereas the remaining 181 (74.5%) reported good pain relief (>50% pain relief). Therefore, of the 410 patients who received trial stimulation, effective long-term pain control was achieved in 59.3 percent of the patients enrolled.
Of the 410 patients studied, only 19 were able to work before SCS therapy. After SCS therapy, this number increased to a total of 58 employed patients in the study group. Fifteen patients who were employed on a part-time basis before the procedure reported significant increases in their time and activity level at work after SCS therapy. No patient who was previously employed became unemployed as a result of SCS therapy. None of the patients who failed trial stimulation were able to return to work during the study period.
Implantable Drug Delivery Systems
Intrathecal drug delivery (IDD) is a proven and effective treatment alternative in carefully selected patients with chronic pain that cannot be controlled by a well-tailored drug regime and/or spinal cord stimulation (SCS), and may be specifically tested in patients who fail to respond to SCS. While the lack of randomized controlled trials is often perceived as a limitation of IDD, many studies attest to the efficacy of this therapy. Good to excellent pain relief is achieved in many patients who have failed more conservative therapies, and there is often a reduced need for analgesia. The advent of patient-controlled analgesia allows flexibility of dosing according to the patient’s needs. Consequently, quality of life improves in many patients and the majority express satisfaction with treatment. Some patients are able to return to work.
The benefits of IDD (including a potent analgesic response with a more stable therapeutic drug level, decreased latency, increased duration of action, and decreased pharmacological complications) mean that side effects such as nausea, vomiting, sedation, and constipation are reduced. In addition, IDD demonstrates long-term cost-effectiveness when compared to conventional pain therapies, addressing a concern that affects many physicians in clinical practice today.
The following criteria are used to determine whether implantable intrathecal drug delivery is appropriate for chronic pain sufferers:
- More conservative therapies have failed to help the pain adequately.
- An observable pathology exists that is associated with the pain.
- Further traditional surgical intervention is not indicated.
- No serious untreated drug habituation exists.
- Psychological evaluation and clearance for implantation have been received.
- No medical issues exist that would present problems with doing the surgery.
- The screening trial is successful.
Studies show that 80% of patients receiving appropriate screening trials experience good to excellent pain relief. For patients with non-malignant pain, withdrawal of all pain medications for seven to 10 days prior to the first stage of the trial assures an ucompromised test and demonstrates the patient’s commitment. Under these conditions, if the bolus injection does not provide pain reduction greater than 60-70%, no further testing with this therapy is warranted. If response to the first stage of the test is positive, however, the patient progresses to the second stage of the test: a two-week trial with an epidural catheter and external pump system. During this second stage patients have the opportunity to test their expectations of the therapy more fully. If the patient experiences continued relief, the system is implanted.
The typical IDD system consists of a pump and catheter. Implantation of the catheter and pump is usually done under general anesthesia, but can be done under local or spinal anesthesia with monitored anesthesia care if the physician desires or the patient’s condition warrants. The pump is implanted subcutaneously, usually in the right or left abdomen. A catheter is introduced into the upper lumbar intrathecal space and the catheter tip is positioned appropriately. The catheter is then tunneled under the skin and connected to the pump.
The pump is programmed to release the medication at a set rate, and the medication flows from the pump, through the catheter to the site of delivery in the intrathecal space. Regular monitoring for dosage adjustments and refills is necessary.
CINN Welcomes Min Kyung Kim, MD to the Physiatry Team
CINN is pleased to announce that Min Kim, MD has joined the Chicago Institute of Neurosurgery and Neuroresearch. Dr. Kim is trained in the diagnosis and treatment of patients with pain of spinal origin, treating occupational and sports related injuries, joint, nerve and musculoskeletal ailments. Her current interests encompass women’s health and obesity.
Dr. Kim specializes in treating back and neck pain, as well as neurologic and orthopedic disorders that lead to a variety of rehabilitative conditions. She performs interventional diagnostic testing, such as discography, selective spinal blocks, and electrodiagnostic testing. She utilizes injection therapy including fluoroscopically guided spinal and peripheral joint injections, minimally invasive spinal interventions, and botox treatments. She also employs an integrated, multi-disciplinary approach to reduce pain and improve the quality of life of her patients.
Dr. Kim earned her medical degree in 2002 from the SUNY Health Science Center at Brooklyn in New York, New York. After receiving her degree, Dr. Kim held an internship at New York Hospital of Queens, Cornell University in New York, New York and a residency in Physical Medicine and Rehabilitation at the Rehabilitation Institute of Chicago, which is affiliated with the Northwestern University Feinberg School of Medicine. Following the completion of her residency in 2006, Dr. Kim joined CINN.
Dr. Kim is bilingual in Korean and English and can be reached at CINN at the Neurologic & Orthopedic Hospital of Chicago at 773/250-0400.