P103. Seven-year outcomes for single-level total disc replacement with a novel viscoelastic artificial cervical disc

• Published in: The spine journal Vol. 24; no. 9; pp. S112 - S113
• Main Authors: Phillips, Frank M., Lavelle, William F., Lanman, Todd H., Milam, Robert Alden, Ledonio, Charles Gerald Tan
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.09.2024
• ISSN: 1529-9430
• DOI: 10.1016/j.spinee.2024.06.125

An Artificial Cervical Disc, with a compressible viscoelastic nuclear core and an annular structure, is substantially different from first generation articulating surface designs. To determine safety and efficacy of subjects who underwent cervical total disc replacement using M6-C A prospective, multicenter, controlled, IDE clinical trial A total of 160 subjects with one-level symptomatic degenerative cervical radiculopathy. NDI, pain scores and subsequent surgical intervention IDE clinical trial is currently in long-term follow-up. Twelve investigational sites are participating in the study, with preoperative assessments followed by 6 weeks, 3 months, 6 months, 1 year, and annually out to 10 years post-implantation. 160 subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled. NDI, pain scores and subsequent surgical interventions were analyzed. NDI and Pain Scores are available for 93 subjects at 7 years postop. Subjects had a mean Neck Disability Index (NDI) score of 9.3 on a 100-point scale, indicating mild disability. There was a mean NDI improvement from baseline of 46.5 points at 7-years. A mean neck Pain VAS Score of 0.8 (out of 10) and a mean shoulder/arm pain VAS Score (worst side) of 0.5 were collected. Through 7 years postop, 11 of the 160 enrolled subjects (6.9%) experienced Subsequent Surgical interventions (SSI) at the index level. These included 9 Removals, 1 Reoperation, and 1 Supplemental Fixation. 5 of the removals were associated with osteolysis, with confirmed infection reported for all 5 subjects. The mean timeframe for removal for osteolysis was 73 months postop (range 54–86 months.) The mean time frame for SSI for other causes was 35 months (range 1-77 months.) The significant reduction in disability and pain associated with subjects who underwent 1-level cervical disc arthroplasty in earlier follow-up periods are maintained at 7-years postop. Seven-year SSI rates are comparable to other commercially available artificial discs. The safety and performance of this novel viscoelastic disc is at par with other disc designs and will continue to be monitored out to 10-years postop. M6-C (Approved for this indication).