Here are 10 key points on artificial disc replacement and where the market is headed.
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1. The global artificial disc replacement market is expected to hit $4.5 billion by 2024, according to a Global Market Insights report. The metal-on-biopolymer segment was the largest in 2017, hitting $1 billion. Over the next five years, the cervical disc segment is expected to have a compound annual growth rate of 22.3 percent.
2. Many insurance companies have policies that cover cervical artificial disc replacement; in July 2018, UnitedHealthcare issued a new policy to cover single-level lumbar total disc replacement in patients with degenerative disc disease after a patient forced a third-party review.
3. The FDA granted clearance for the M6-C cervical disc, originally developed by Spinal Kindetics and acquired by Orthofix. The next-generation disc technology was designed to restore physiologic motion of the spine, including an artificial visco-elastic nucleus and fiber annulus incorporated into the disc. The device is expected to have a limited, controlled release in the U.S. this year to accommodate surgeon training and education.
4. Centinel Spine acquired assets of the prodisc Total Disc Replacement portfolio from DePuy Synthes in late 2017. The products include cervical and lumbar total disc replacement technology. A study published in the European Spine Journal in 2017 examined clinical and radiological outcomes 10 years after total disc replacement with the prodisc-C technology and found a low implant-related reoperation rate and low rate of symptomatic adjacent segment disease.
5. The International Journal of Spine Surgery published an article in 2017 examining the long-term evidence of cervical disc replacement with Mobi-C technology, developed by LDR and acquired by Zimmer Biomet. The study included 599 patients who underwent spine surgery, 164 who underwent one-level total disc replacement, 225 who underwent two-level disc replacement, 81 who underwent one-level anterior cervical discectomy and fusion, and 105 who underwent two-level ACDF.
After an average of seven year follow-ups, the success of two-level disc replacement was 60.8 percent, compared to 34.2 percent for ACDF. One-level disc replacement success was 55.2 percent at seven years after surgery, compared to 50 percent for one-level ACDF. The study authors concluded "At seven years, the composite success analysis demonstrated clinical superiority of two-level TDR over ACDF and non-inferiority of single-level TDR versus ACDF."
6. Total disc replacement is also safe and effective in the outpatient setting, according to a study published in a 2018 edition of the International Journal of Spine Surgery. The study included data from 145 patients who underwent cervical disc replacement in ASCs, 348 who underwent the surgery as hospital outpatients and 65 who had the procedure inpatient. Study authors found:
• Surgery times were the shortest in ASCs at 63.6 minutes.
• Blood loss was lowest in the ASC at 18.5 mL, compared to 43.7 mL in the HOPD and 65.7 mL in the hospital inpatient.
• One device or surgery related adverse event was reported in the ASC, compared to 10 in the hospital setting.
7. CMS updated its payment policies to include total disc replacement in 2018. The agency calculates the total cost for disc replacement in the ASC as $11,213, compared to $15,371 in the hospital outpatient department.
Two key thoughts from spine surgeons about disc replacements:
Justin Park, MD. The Maryland Spine Center at Mercy Medical Center (Baltimore): I think that motion-preservation technologies such as cervical disc replacement will become a bigger player in the surgical toolbox of spine surgeons. As insurance companies such as Medicare have become more open minded in approving these surgeries in the last five years, we will see a growing population of patients with excellent results from long-term follow-up.
Jason M. Cuéllar, MD, PhD. Assistant Professor in the Department of Orthopaedic Surgery at Cedars-Sinai Medical Center (Los Angeles): Our patients are expecting to be more physically active at greater ages than in prior generations. Motion-preservation devices will allow spine surgeons to improve patients while taking into consideration the long-term health of the spine, reducing rates of future surgery caused by adjacent-segment failure. In addition to taking into consideration our patients' long-term spinal health, we have some responsibility for the cost-effectiveness and durability of the procedures that we utilize. There is significant evidence that artificial disc replacement is more cost-effective than fusion. (Ament JD, Yang Z, Nunley P, et al. Cost Utility Analysis of the Cervical Artificial Disc vs Fusion for the Treatment of 2-Level Symptomatic Degenerative Disc Disease: 5-Year Follow-up. Neurosurgery 2016;79:135-45.)