Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial

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OBJECTIVE

The authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF).

METHODS

A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted comparing the low-profile titanium ceramic composite–based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from a postapproval study were available on 148 CDA and 118 ACDF patients and are reported here. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative follow-up intervals for up to 10 years. The primary endpoint was overall success, a composite variable that included key safety and efficacy considerations. Ten-year follow-up rates were 86.0% for CDA and 84.9% for ACDF.

RESULTS

From 2 to 10 years, CDA demonstrated statistical superiority over ACDF for overall success, with rates at 10 years of 80.4% versus 62.2%, respectively (posterior probability of superiority [PPS] = 99.9%). Neck Disability Index (NDI) success was also superior, with rates at 10 years of 88.4% versus 76.5% (PPS = 99.5%), as was neurological success (92.6% vs 86.1%; PPS = 95.6%). Improvements from preoperative results in NDI and neck pain scores were consistently statistically superior for CDA compared to ACDF. All other study effectiveness measures were at least noninferior for CDA compared to ACDF through the 10-year follow-up period, including disc height. Mean angular ranges of motion at treated levels were maintained in the CDA group for up to 10 years. The rates of grade IV heterotopic ossification (HO) at the superior and inferior levels were 8.2% and 10.3%, respectively. The rate of severe HO (grade III or IV) did not increase significantly from 7 years (42.4%) to 10 years (39.0%). The CDA group had fewer serious (grade 3–4) implant-related or implant/surgical procedure–related adverse events (3.8% vs 8.1%; posterior mean 95% Bayesian credible interval [BCI] of the log hazard ratio [LHR] −0.92 [−1.88, −0.01]). The CDA group also had statistically fewer secondary surgical procedures at the index levels (4.7%) than the ACDF group (17.6%) (LHR [95% BCI] −1.39 [−2.15, −0.61]) as well as at adjacent levels (9.0% vs 17.9%).

CONCLUSIONS

The Prestige LP Cervical Disc, implanted at two adjacent levels, maintains improved clinical outcomes and segmental motion 10 years after surgery and is a safe and effective alternative to fusion.

Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)

ABBREVIATIONS ACDF = anterior cervical discectomy and fusion; AE = adverse event; BCI = Bayesian credible interval; CDA = cervical disc arthroplasty; cTDR = cervical TDR; DDD = degenerative disc disease; FSU = functional spinal unit; HO = heterotopic ossification; HPD = highest posterior density; IDE = investigational device exemption; LHR = log hazard ratio; MCS = Mental Component Summary of SF-36; NDI = Neck Disability Index; PAS = postapproval study; PCS = Physical Component Summary of SF-36; PPS = posterior probability of superiority; ROM = range of motion; TDR = total disc replacement.

Article Information

Correspondence Matthew F. Gornet: The Orthopedic Center of St. Louis, St. Louis, MO. mfgspine@gmail.com.

INCLUDE WHEN CITING Published online June 21, 2019; DOI: 10.3171/2019.4.SPINE19157.

Disclosures The clinical trial was sponsored by Medtronic, Inc., Memphis, TN; they provided access to the data and statistical analyses. The investigational device exemption and postapproval study was also sponsored by Medtronic, Memphis, TN. M. F. Gornet reports being a consultant for Aesculap and Medtronic; direct stock ownership in Bonovo, International Spine & Orthopedic Institute, LLC, Nocimed, OuroBoros, and Paradigm Spine; and receiving royalties from Medtronic and RTI. T. H. Lanman reports being a consultant for Medtronic, NuVasive, and Stryker; receiving royalties from Stryker and Medtronic, and being a patent holder with Medtronic and Stryker. J. K. Burkus reports being a consultant for Medtronic and Zimmer-Biomet; receiving royalties from Zimmer-Biomet; and receiving research support from Medtronic and NuVasive. R. F. Dryer reports being a consultant for and receiving royalties from NuVasive and Globus Medical. J. R. McConnell reports being a consultant for Globus Medical, DePuy/Synthes, and IMSE; receiving royalties from Globus Medical; direct stock ownership in Globus Medical; being on the speakers bureau for Globus Medical and Zimmer-Biomet; and being a patent holder with IMSE. S. D. Hodges reports being a consultant for Medtronic. F. W. Schranck reports direct stock ownership in Nocimed.

© AANS, except where prohibited by US copyright law.

Headings

Figures

  • View in gallery

    Success rates over time for both the CDA and ACDF groups for the efficacy measures overall success (A), NDI success (B), and neurological success (C). PPS > 95% considered statistically superior. Y = years.

  • View in gallery

    Mean scores over time for both the CDA and ACDF groups for efficacy measures NDI score (A), neck pain score (B), arm pain score (C), and SF-36 PCS score (D). For NDI, neck pain, and arm pain, a lower score indicates less disability or pain. For SF-36 PCS, a higher score means better functioning. PPS based on the between-treatment comparisons of score improvements from preoperative; PPS > 95% considered statistically superior. M = months; WK = weeks.

  • View in gallery

    Radiographic outcomes. FSU success rates for the CDA and ACDF groups over time (A), with no statistical difference at any point of long-term follow-ups, and mean ROM over time at superior and inferior levels of the CDA patients (B). deg. = degrees.

  • View in gallery

    Rates of secondary surgeries involved with adjacent levels over time for the CDA and ACDF groups. PPS > 95% considered statistically superior.

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