Food and Drug Administration–approved investigational device exemption (IDE) studies have provided level I evidence supporting cervical disc arthroplasty (CDA) as a safe and effective alternative to anterior cervical discectomy and fusion (ACDF). Long-term CDA outcomes continue to be evaluated. Here, the authors present outcomes at 10 years postoperatively for the single-level CDA arm of an IDE study (postapproval study).
The primary endpoint was overall success, a composite variable composed of five criteria: 1) Neck Disability Index score improvement ≥ 15 points; 2) maintenance or improvement in neurological status; 3) no decline in anterior or posterior functional spinal unit (FSU) height of more than 2 mm compared to 6 weeks postoperatively; 4) no serious adverse event (AE) caused by the implant or the implant and the surgical procedure; and 5) no additional surgery classified as a failure. Additional safety and effectiveness measures included numeric rating scales for neck pain and arm pain, SF-36 quality-of-life physical and mental components, patient satisfaction, range of motion, and AEs.
From the reported assessments at 7 years postoperatively to the 10-year postoperative follow-up, the scores for all patient-reported outcomes, rate of overall success (without FSU), and proportion of patients at least maintaining their neurological function remained stable for the CDA group. Nine patients had secondary surgery at the index level, increasing the secondary surgery cumulative rate from 6.6% to 10.3%. In that same time frame, four patients experienced a serious implant or implant/surgical procedure–related AE, for a 10-year cumulative rate of 7.8%. Seven patients had any second surgery at adjacent levels, for a 10-year cumulative rate of 13.8%. Average angular motion at both the index and adjacent levels was well maintained without creating hypermobility. Class IV heterotopic ossification increased from 1.2% at 2 years to 4.6% at 7 years and 9.0% at 10 years. Patient satisfaction was > 90% at 10 years.
CDA remained safe and effective out to 10 years postoperatively, with results comparable to 7-year outcomes and with high patient satisfaction.
Correspondence Matthew F. Gornet: The Orthopedic Center of St. Louis, St. Louis, MO. firstname.lastname@example.org.
INCLUDE WHEN CITING Published online May 10, 2019; DOI: 10.3171/2019.2.SPINE1956.
Disclosures The investigational device exemption study was sponsored by Medtronic (Memphis, TN). The authors report the following potential or perceived conflicts: Dr. Gornet: consulting: Aesculap and Medtronic; stock ownership: Bonovo, International Spine & Orthopedic Institute, LLC, Nocimed, OuroBoros, and Paradigm Spine; royalties: Medtronic and RTI. Dr. Burkus: consulting: NuVasive; royalties: Zimmer-Biomet. Ms. Schranck: stock ownership: Nocimed.
BurkusJKTraynelisVCHaidRWJrMummaneniPV: Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: clinical article. J Neurosurg Spine21:516–5282014
CoricDNunleyPDGuyerRDMusanteDCarmodyCNGordonCR: Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine15:348–3582011
GuyerRDShellockJMacLennanBHanscomDKnightRQMcCombeP: Early failure of metal-on-metal artificial disc prostheses associated with lymphocytic reaction: diagnosis and treatment experience in four cases. Spine (Phila Pa 1976)36:E492–E4972011
HackerFMBabcockRMHackerRJ: Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site. Spine (Phila Pa 1976)38:2223–22262013
HarrodCCHilibrandASFischerDJSkellyAC: Adjacent segment pathology following cervical motion-sparing procedures or devices compared with fusion surgery: a systematic review. Spine (Phila Pa 1976)37 (22 Suppl):S96–S1122012
HermansenAHedlundRVavruchLPeolssonA: A comparison between the carbon fiber cage and the Cloward procedure in cervical spine surgery: a ten- to thirteen-year follow-up of a prospective randomized study. Spine (Phila Pa 1976)36:919–9252011
HiseyMSZiglerJEJacksonRNunleyPDBaeHWKimKD: Prospective, randomized comparison of one-level Mobi-C cervical total disc replacement vs. anterior cervical discectomy and fusion: results at 5-year follow-up. Int J Spine Surg10:102016
JanssenMEZiglerJESpivakJMDelamarterRBDardenBVIIKopjarB: ProDisc-C total disc replacement versus anterior cervical discectomy and fusion for single-level symptomatic cervical disc disease: seven-year follow-up of the prospective randomized U.S. Food and Drug Administration Investigational Device Exemption Study. J Bone Joint Surg Am97:1738–17472015
LanmanTHBurkusJKDryerRGGornetMFMcConnellJHodgesSD: Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial. J Neurosurg Spine27:7–192017
LavelleWFRiewKDLeviAFlormanJE: 10-year outcomes of cervical disc replacement with the BRYAN® cervical disc: results from a prospective, randomized, controlled clinical trial. Spine (Phila Pa 1976)44:601–6082019
PhillipsFMGeislerFHGilderKMReahCHowellKMMcAfeePC: Long-term outcomes of the US FDA IDE prospective, randomized controlled clinical trial comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. Spine (Phila Pa 1976)40:674–6832015
SassoRCAndersonPARiewKDHellerJG: Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. J Bone Joint Surg Am93:1684–16922011
SinghVSkiporAKSelimAAJacobsJJ: Chromium and nickel concentrations in subjects with a stainless steel metal-on-metal cervical disc arthroplasty: results from a prospective longitudinal study with 7 years follow-up. Int J Spine Surg12:460–4682018
VermaKGandhiSDMaltenfortMAlbertTJHilibrandASVaccaroAR: Rate of adjacent segment disease in cervical disc arthroplasty versus single-level fusion: meta-analysis of prospective studies. Spine (Phila Pa 1976)38:2253–22572013