Becker's Spine Review

30 Spine Device & Innovation Short-term data shows cervical spinal arthroplasty could deliver the same — po- tentially better — outcomes than spinal fusion for appropriately indicated patients. Still, many surgeons in the field have held out for long-term data, which is just beginning to roll in. "In the properly selected patients, cervical disc replacement is at least as ben- eficial as fusion," says Todd Albert, MD, President of Rothman Institute in Philadelphia. "The long term data generally shows us favorable results. In some studies the outcomes appear better than fusion. Also a small number of studies have suggested a higher re-operation rate in the fusion group. These findings will lower one barrier to usage in properly indicated patients." An article published in an early 2014 edition of The Spine Journal examined the ProDisc II from Synthes and followed patients for five to 10 years. Among the 181 patients, researchers found: • Highly significant improvements in baseline visual analog scale and Os- westry disability index scores at all levels postoperatively. • VAS scores had a slight deterioration from 48 months onward • Patient satisfaction remained stable, with 63.6 percent reporting high satisfaction and 22.7 percent reporting satisfactory outcomes. • There was a complication rate of 14.4 percent. • Incidence of revision for general or device-related complications was 7.2 percent. • Two-level replacements also demonstrated significant VAS and ODI scores over baseline, but those results were significantly inferior to one- level cases. A 2013 study published in Spine examining the ProDisc-C at 13 different treatment sites compared cervical disc replacement with spinal fusion. The researchers found: • After five years, patients who underwent TDR had a 97.1 percent prob- ability of no secondary procedures, compared with 85.5 percent for ACDF patients. • No reoperations in TDR patients were due to implant breakage or de- vice failure. • Pseudarthrosis was the most common reason for reoperation at the index level among ACDF patients. • Recurrent neck pain and/or arm pain was the most common reason for reoperation at the adjacent level for both groups. • Only 2.9 percent of TDR patients had reoperations within five years of the initial surgery, compared with 14.5 percent of the ACDF patients. Similar studies with new devices on the market will make an impact on the future of the procedure. In 2012, the U.S. Food and Drug Administration approved two cervical total disc replacement devices. A 2013 Research and Markets analysis predicted non-fusion procedures will gain popularity and adoption in coming years, and surgeons will begin exploring motion preser- vation technologies due to physical restrictions and degeneration of adjacent segments that spinal fusion can cause. "All discs approved now have ranges of motion most compatible with flex- ion/extension, lateral bending," says Dr. Albert. "Future approved discs will hopefully have compliance/cushioning to more closely recapitulate the nor- mal disc." Some surgeons are performing cervical disc arthroplasties in the outpa- tient ambulatory surgery center setting. Richard Wohns, MD, founder of NeoSpine in the Puget Sound Area, Wash., published an article describing the cost-effectiveness of outpatient cervical disc arthroplasty in Surgical Neurology Internation- al in 2010. The article reviewed 26 patients who underwent outpatient cervical disc arthro- plasty and found 100 percent of patients improved after the surgery and no postoperative complications. The cost of outpatient single- level cervical disc arthroplasty was 62 percent less than outpa- tient single-level anterior cervi- cal discectomy with fusion using allograft and plate. The arthro- plasty procedure cost 84 percent less in the outpatient ASC than inpatient hospital setting. Despite the potential for positive outcomes with cervical disc arthroplasty, reimbursement remains a barrier for many surgeons and patients. "Some insurers still will not cover disc replacement despite the excellent and high-quality data demonstrating its safety and efficacy," says Dr. Albert. n Cervical Artificial Disc Replacement: What the Long-Term Data Means for Spine (continued from cover) How Spine Surgeons Treat Recurrent Disc Herniation By Laura Miller A study led by Christoph J. Siepe, MD, PhD, with results pub- lished in an early 2014 edition of The Spine Journal examined the ProDisc II from Synthes and followed patients for five to 10 years. The researchers found: 1. Surgeons who were in practice 15 or more years were more likely to select revision microdiscectomy. 2. Surgeons who had fewer than 15 years of practice were more likely to select revision microdiscectomy with PLIF/TLIF. 3. Surgeons who performed more than 200 surgeries per year were more likely to select revision microdiscectomy with PLIF/TLIF than those with fewer surgeries. 4. There was a 69 percent probability that two randomly selected spine surgeons would disagree on how to treat two-time recurrent disc herniation. 5. There was a 22 percent probability that two randomly selected spine surgeons would disagree on how to treat one-time recurrent disc herniation. There were no significant differences for region of the country, spe- cialty, fellowship training or practice type. n Dr. Todd Albert

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