Seven-year follow-up data for the two-level application of the Prestige LP cervical disc (Medtronic) has shown favourable clinical outcomes and patient satisfaction for the artificial disc over two-level anterior cervical discectomy and fusion (ACDF).
The data was presented at the 84th American Association of Neurological Surgeons meeting in Chicago, USA, by Todd Lanman, a neurosurgeon at the Cedar-Sinai Institute for Spinal Disorders in Los Angeles, USA.
“The seven-year results of this study show that the patients receiving two-level cervical disc replacement exhibited beneficial clinical outcomes and maintained them over time,” says Lanman. “At 84 months, the patients treated with the 2-level Prestige LP disc demonstrated greater rates of overall success compared to the two-level ACDF patients.”
The disc—which is pending US Food and Drug administration premarket approval—is designed to preserve motion at the operated disc level. Its ball-and-trough design is intended to allow the disc to move in a range of motions; bending, rotating and translating.
The randomised controlled investigational device exemption (IDE) trial included a total of 397 study subjects (209 investigational and 188 control) and compared results up to seven years. Key findings of the statistical analysis at seven years show that the two-level Prestige LP disc patients:
- Exhibited greater rates in overall success (78.6%) compared to the patients treated with two-level ACDF (62.7%) (by using Bayesian statistics, probability of superiority = 99.8%).
- Exhibited greater rates in neurological success (91.6%) compared to the patients treated with two-level ACDF (82.1%) (probability of superiority= 99.0%).
- Exhibited greater success rates in patient-reported outcomes, including Neck Disability Index (87.0%), compared to the patients treated with two-level ACDF (75.6%) (probability of superiority = 99.3%).
- Exhibited lower rates of second surgeries (4.2%) at the index levels compared to the patients treated with two-level ACDF (14.7%).
- Adverse event profiles were similar between groups.
- Risks of the Prestige LP disc include, but are not limited to: bone formation (including heterotopic ossification) that may reduce spinal motion or result in a fusion, either at the treated or at adjacent levels.