Prospective, Multicenter Study of Two-Level Cervical Arthroplasty With a PEEK-On-Ceramic Cervical Total Disc...

Area of Science:

• Neurosurgery
• Orthopedic Surgery
• Spinal Surgery

Background:

• Cervical total disc replacement (cTDR) is increasingly accepted for cervical degenerative disc disease (DDD).
• Long-term outcomes, especially for two-level procedures, require further investigation.
• Polyetheretherketone (PEEK)-on-ceramic technology is utilized in modern cTDR devices.

Purpose of the Study:

• To assess the 5-year clinical and radiographic outcomes of the Simplify cTDR device.
• To evaluate the safety and efficacy of two-level cTDR for cervical radiculopathy/myelopathy.
• To analyze patient-reported outcomes and reoperation rates at intermediate follow-up.

Main Methods:

• Prospective, nonrandomized cohort analysis of patients undergoing two-level cTDR (Simplify device).
• Patients were followed for 36 to 60 months post-implantation.
• Data collected included clinical success, Neck Disability Index, pain scores, reoperation rates, and range of motion.

Main Results:

• 80% of 181 patients completed 5-year follow-up.
• Clinical success remained high (86% at 5 years vs. 88% at 2 years).
• Sustained improvements in Neck Disability Index, neck pain, and arm pain were observed. Five-year cumulative reoperation rates were 5% at the index level and 2.2% at adjacent levels. Segmental range of motion was preserved.

Conclusions:

• The Simplify cTDR is safe and effective for treating two-level symptomatic cervical DDD.
• Five-year outcomes demonstrate sustained or improved clinical benefits compared to 2-year results.
• The device offers motion preservation and low reoperation rates at index and adjacent levels.