Newswise — DENVER (April 11, 2011) − Thousands of Americans suffer from episodes of acute or persistent neck and arm pain every year as a result of underlying cervical disc disease. Anterior cervical discectomy and fusion (ACDF) has been the mainstay treatment for many years. More than 200,000 cervical procedures are performed each year to relieve compression on the spinal cord or nerve roots. Spinal fusion surgery creates a solid union between two or more vertebrae to help strengthen the spine and alleviate chronic neck pain.
The first artificial cervical disc was introduced and received FDA approval in 2007. Since then, two other artificial cervical discs have been FDA approved. The goals of artificial cervical disc surgery are to remove the diseased disc, restore normal disc height, decrease neck pain and associated arm pain/weakness, preserve motion in the affected vertebral segment, and improve patient function. In comparison to spinal fusion surgery, potential benefits of artificial disc surgery (arthroplasty) may include more spine mobility after surgery and less stress on adjacent discs. “Given that this is a relatively new technology, this is the largest combined analysis of class 1 data to date comparing the efficacy of arthroplasty to the ACDF procedure,” said lead author Praveen V. Mummaneni, MD.
Researchers at the University of California, San Francisco, Richland, Washington, Rush University Medical Center, Atlanta Brain and Spine Care, Carolina Neurosurgery & Spine Associates, and University of Wisconsin, Madison, compared the efficacy of three artificial cervical discs: PRESTIGE ST, BRYAN, and Pro-Disc-C with ACDF. The results of this study, Analysis of Three Randomized, Prospective, US FDA IDA Trials Comparing Cervical Arthroplasty and ACDF, will be presented by Dr. Mummaneni, 4:01-4:15 pm, Monday, April 11, during the 79th Annual Scientific Meeting of the American Association of Neurological Surgeons in Denver. Co-authors are Cheerag D. Upadhyaya, MD, MSc, Jau Ching Wu, MD, Regis W. Haid Jr., MD, Vincent C. Traynelis, MD, Bobby Tay, MD, Domagoj Coric, MD, and Gregory Trost, MD.
A total of 1,213 total patients were randomized into two treatment arms in the three FDA IDA trials. The two groups had no statistical differences in age, sex, tobacco usage, litigation involvement, preoperative work status, or workman’s compensation claims. Additional patient demographics:
•Artificial cervical disc received by 621 patients•ACDF received by 592 patients•Mean ages in three FDA-IDE trials: 42-44•Gender: 51 percent male, 44 percent female•Full 2-year follow-up completed by 94 percent of the arthroplasty group, 87 percent of the ACDF group.
Data was analyzed from these two groups and included previously unpublished source data. Statistical analysis was performed with a random effects model. The following results were noted:
•Segmental motion among the arthroplasty group was 7° preoperatively and 8° postoperatively, and all three devices demonstrated maintained range of motion at 2 years.•The fusion group had no segmental motion postoperatively and had a 95 percent fusion rate. •The 2-year pooled risk ratio for adjacent level surgery was 0.48 (95 percent CI 0.24-0.96, I²=1.7 percent, p<0.05).•The pooled risk ratio for supplemental surgery was 0.14 (95 percent CI 0.03-0.72, I²=0.0 percent, p<0.05).•Other parameters such as NDI score and SF-36 showed no statistical differences between groups.
“ACDF and artificial cervical discs both have excellent two year surgical results for one-level cervical disc disease with radiculopathy. We found that the artificial cervical discs were associated with lower rates of repeat surgery two years after implantation compared to ACDF. While both of these procedures yielded good results, the most important factor is proper patient selection,” said Dr. Mummaneni.
Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons (AANS) is a scientific and educational association with more than 8,000 members worldwide. The AANS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. All active members of the AANS are certified by the American Board of Neurological Surgery, the Royal College of Physicians and Surgeons (Neurosurgery) of Canada or the Mexican Council of Neurological Surgery, AC. Neurological surgery is the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affect the entire nervous system, including the spinal column, spinal cord, brain and peripheral nerves.
Disclosure: Dr. Mummaneni is a consultant for DePuy Spine, a Johnson & Johnson company and receives royalties from DePuy unrelated to this study. He was a consultant for Medtronic in the past.
Media Representatives: If you would like to cover the meeting or interview a neurosurgeon − either on-site or via telephone − please contact the AANS Communications Department at (847) 378-0517 or call the Annual Meeting Press Room beginning Monday, April 11 at (303) 228-8431.
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