Cervical Disc Replacement · Mr Patrick J. McKenna

Overview

Motion Preservation for the Cervical Spine

Cervical total disc replacement (c-TDR) is now a well-established alternative to anterior cervical discectomy and fusion (ACDF) for appropriately selected patients with cervical radiculopathy or myelopathy. Nine devices currently hold FDA approval for single-level use, with several extended to two contiguous levels on the strength of long-term IDE trial data.

Mr McKenna selects between four cervical prostheses depending on patient anatomy, level, and clinical presentation. Each device below is summarised with its design rationale, key features, and the long-term, FDA and IDE evidence supporting its use — with direct links to the primary studies.

For a broader summary of the cervical arthroplasty evidence base, see the Cervical Spine Evidence page.

The Implants

The Cervical Disc Replacements Used by Mr McKenna

Four next-generation cervical disc prostheses, each engineered to restore natural motion at the treated level while avoiding the biomechanical consequences of fusion.

FH Orthopaedics

CP-ESP® Cervical Disc

A one-piece viscoelastic cervical total disc replacement with a polycarbonate-urethane core bonded to hydroxyapatite-coated titanium endplates, designed to reproduce the natural shock-absorbing behaviour of the intervertebral disc without a mechanically articulating bearing surface.

One-piece viscoelastic PCU core — no articulating-surface wear debris
Hydroxyapatite-coated titanium endplates for bony ingrowth
Anatomically contoured for single- and two-level use, C3–C7
Over 5,000 implantations across Europe since 2012

Long-term evidence: a two-year multicentre follow-up (Chin et al., J Spine Surg 2018) and a dedicated cervical myelopathy cohort (J Pers Med 2023) both report sustained improvement in pain and disability scores. CP-ESP is CE-marked and used throughout Europe; it is not yet the subject of a completed US FDA IDE trial, so device-specific 5–10 year data continues to accumulate.

Centinel Spine

prodisc® C Vivo

The latest generation of the prodisc ball-and-socket cervical disc, using a fixed-core articulation with modular keel fixation. Part of the most extensively studied total disc replacement platform in the world, with over 300,000 prodisc implantations globally.

Fixed-core ball-and-socket articulation
FDA-approved for both one- and two-level cervical disc disease
Highest reported two-level composite clinical success of any approved cervical TDR in its pivotal trial
Backed by the prodisc family's 25+ year clinical pedigree

Long-term evidence: a single-centre five-year follow-up (PubMed 33988531) reported satisfactory clinical and radiographic outcomes. Two-level use received FDA IDE approval on the strength of an 87.1% composite clinical success rate (vs. 83.7% for the control TDR), from the registered IDE studies NCT03367052 and NCT03367039.

Spineart

Baguera®C Disc

A self-centring, mobile-bearing cervical disc with diamond-like-carbon-coated articulating surfaces — the cervical counterpart to the Baguera®L lumbar prosthesis Mr McKenna also uses. Its mobile core dynamically finds its optimal position, closely mimicking natural disc kinematics.

Self-centring mobile polyethylene bearing
Diamond-like carbon (DLC) coated articulating surfaces
Longest published follow-up (10 years) of any device in this cohort
US IDE trials completed enrolment for both one- and two-level indications

Long-term evidence: a 10-year clinical and radiological follow-up (Eur Spine J, 2023) of 91 patients (113 prostheses) reported 82.7% of patients pain-free, patient satisfaction over 90%, and a 1% reoperation rate, with no migration, subsidence or dislocation. Spineart's US IDE programme comparing BAGUERA®C against Mobi-C has completed enrolment at both one level (NCT04520776) and two contiguous levels (NCT04564885).

Synergy Spine Solutions

Synergy® Disc

An alignment-driven cervical disc with a lordotic polyethylene core engineered to restore and maintain physiological cervical curvature while preserving segmental motion — the newest addition to Mr McKenna's cervical arthroplasty practice, FDA-approved in February 2026.

Lordotic polyethylene core restores physiological alignment
FDA Premarket Approval (PMA) granted February 2026, one-level use C3–C7
Statistically superior composite clinical success vs. ACDF in its pivotal US trial
Over 10 years of commercial experience outside the United States

Long-term evidence: the multicentre US ALIGN-1L IDE trial (177 patients, 20 sites) found the Synergy Disc achieved 87.1% composite clinical success at 24 months versus a historical ACDF control (p<0.0001), supporting FDA approval in February 2026. Post-market long-term follow-up is registered under NCT06383962.

Why cervical disc replacement over fusion? Motion-preserving cervical arthroplasty removes the diseased disc while maintaining segmental mobility — reducing the biomechanical stress on adjacent levels that drives adjacent segment disease. Long-term FDA IDE trial data consistently shows lower reoperation rates and higher patient satisfaction compared with ACDF for appropriately selected patients.

Selected Literature

Long-Term, FDA & IDE References

The studies below underpin the long-term, FDA-regulatory and Investigational Device Exemption (IDE) evidence for each cervical disc prosthesis used by Mr McKenna, together with two broader reviews of the FDA IDE literature for cervical arthroplasty as a whole.

FH OrthopaedicsCP-ESP® Cervical Disc

Chin KR, et al. Clinical experience and two-year follow-up with a one-piece viscoelastic cervical total disc replacement. J Spine Surg. pmc.ncbi.nlm.nih.gov/articles/PMC5760417
Clinical and Radiological Outcome of Disc Arthroplasty for the Treatment of Cervical Spondylotic Myelopathy. J Pers Med. 2023;13(4):592. doi.org/10.3390/jpm13040592

Centinel Spineprodisc® C Vivo

Single-level Cervical Arthroplasty with prodisc-C Vivo Artificial Disc: Five-year Follow-up Results From One Center. pubmed.ncbi.nlm.nih.gov/33988531
Centinel Spine Receives Two-Level FDA Approval for prodisc C Vivo and prodisc C SK Match-the-Disc Cervical Total Disc Replacement Devices. prnewswire.com
A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of prodisc-C Vivo. ClinicalTrials.gov NCT03367039
Clinical and Radiological Outcomes: Two-level Cervical prodisc-C Vivo Versus Hybrid Construct. ClinicalTrials.gov NCT03367052

SpineartBaguera®C Disc

Cervical disc arthroplasty with the Baguera C prosthesis: clinical and radiological results of a 10-year follow-up study. Eur Spine J. 2023. spineart.com/us/publications
A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C for the Treatment of Single Level Cervical Disc Disease. ClinicalTrials.gov NCT04520776
A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C for the Treatment of Cervical Disc Disease at 2 Contiguous Levels. ClinicalTrials.gov NCT04564885
Spineart Completes Enrollment in the BAGUERA®C IDE Trial for Two-Level Cervical Disc Replacement. prnewswire.com

Synergy Spine SolutionsSynergy® Disc

Synergy Spine Solutions Receives FDA Approval for its Synergy Disc, Expanding Cervical Disc Replacement Options for U.S. Patients. prnewswire.com
Dr. Todd H. Lanman Presented Alignment-Driven Synergy Disc Results and Case Experience — ALIGN-1L IDE trial. accessnewswire.com
Post-Market Data Collection to Evaluate the Performance of the Synergy Disc. ClinicalTrials.gov NCT06383962

Broader FDA IDE LiteratureCervical Arthroplasty in General

Parish JM, Coric D. Cervical Arthroplasty: Long-Term Outcomes of FDA IDE Trials. Global Spine J. 2020. pubmed.ncbi.nlm.nih.gov/32528808
Long-Term Outcomes of Cervical Disc Replacement and Anterior Cervical Discectomy and Fusion: A Review of FDA IDE Trials With Real-World Comparison. pmc.ncbi.nlm.nih.gov/articles/PMC12474576

Provided for clinical reference. Device approval status, indications and available follow-up duration vary by prosthesis and are subject to change as further data is published.

Cervical DiscReplacement