Clinical Evidence · Cervical Arthroplasty
Evidence Overview
Cervical total disc replacement (c-TDR) has moved from an emerging alternative to a well-evidenced, established option for degenerative disc disease of the neck. Nine devices now hold FDA approval for single-level use, with three of those extended to two contiguous levels on the strength of long-term IDE trial data.
The evidence base spans FDA Investigational Device Exemption (IDE) randomised controlled trials, post-market registries, and long-term follow-up studies now extending to 7 and 10 years for several devices — a level of scrutiny and maturity comparable to that seen in lumbar disc arthroplasty.
Mr McKenna offers cervical disc replacement using the CP-ESP, prodisc® C Vivo, Baguera®C and Synergy® Disc prostheses. See the Cervical Disc Replacement page for a device-by-device breakdown with full study references.
Summary of Key Arguments
Randomised, multicentre US FDA IDE trials — the same rigorous regulatory pathway required of any new spinal device — have repeatedly shown cervical arthroplasty to be non-inferior, and in several trials statistically superior, to anterior cervical discectomy and fusion (ACDF).
By preserving motion at the treated level, cervical arthroplasty reduces the abnormal compensatory loading on neighbouring discs that drives adjacent segment disease — historically the leading long-term cause of reoperation after ACDF.
Segmental range of motion is maintained at the treated level in the large majority of patients, with perioperative complication rates equivalent to fusion across FDA IDE cohorts.
Published follow-up now extends to 7 years for Mobi-C and 10 years for Baguera®C, with patient-reported outcomes maintained or improved beyond the 5-year mark rather than deteriorating.
Across pivotal IDE trials, patients treated with cervical arthroplasty have consistently required fewer reoperations, revisions and supplemental fixations at the index and adjacent levels than fusion controls.
Newer alignment- and viscoelastic-focused designs — including the Synergy Disc and CP-ESP — continue to refine outcomes, with FDA approvals as recent as February 2026 reflecting continued innovation in the space.
The Evidence at a Glance
Sources: International Journal of Spine Surgery 2017 (Mobi-C 7-year IDE data); Eur Spine J 2023 (Baguera®C 10-year follow-up); Centinel Spine and Synergy Spine Solutions FDA IDE submission data. Full citations with links are provided on the Cervical Disc Replacement page.
Patient Selection
Comparison
| Cervical Disc Replacement | ACDF (Fusion) | |
|---|---|---|
| Principle | Motion preservation — replaces the disc with an articulating or viscoelastic implant | Motion elimination — fuses the segment with bone graft and a plate |
| Adjacent Segment Risk | Reduced — maintains near-normal segmental loading | Elevated — the established leading cause of long-term reoperation |
| Reoperation Rate | Lower across FDA IDE trials and long-term (7–10yr) follow-up | Higher; remains the traditional benchmark comparator |
| Range of Motion | Preserved at the treated level in the large majority of patients | Permanently eliminated at the fused level |
| Recovery | Comparable or faster — no fusion mass required to consolidate | Typically 3–6 months for solid arthrodesis |
| Patient Satisfaction | Equal to or higher than fusion in head-to-head IDE trials | Good, but consistently at or below TDR in comparative trials |
| Evidence Base | 9 FDA-approved devices; up to 10-year published follow-up | Extensive — decades of long-term data; remains the traditional standard |
| Applicability | Requires preserved anatomy and a mobile motion segment | Broader indications, including deformity, instability and multi-level disease |
Further Reading
Two broad reviews of the cervical arthroplasty FDA IDE literature are listed below. Device-specific long-term, FDA and IDE study references for the CP-ESP, prodisc® C Vivo, Baguera®C and Synergy® Disc — each with direct links to the primary source — are provided in full on the Cervical Disc Replacement page.