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

Abstract

<jats:sec><jats:title>OBJECTIVE</jats:title><jats:p>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).</jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p>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%).</jats:p></jats:sec><jats:sec><jats:title>CONCLUSIONS</jats:title><jats:p>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.</jats:p><jats:p>Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)</jats:p></jats:sec>

Long‐term Results Comparing Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

“…A total of 814 studies were removed because they were duplicates, 1076 studies were excluded based on their titles and abstracts, and 43 studies were excluded for other reasons. As a result, 21 studies were included for further evaluation. Among them, 2 studies were partial results of multicenter RCT and 8 studies included duplicated data for publication.…”

“…The basic characteristics of the included studies and patients are summarized in Table . Among them, 8 studies compared single‐level CDD, 1 study compared two‐level CDD, and 2 studies compared both single‐level and two‐level CDD independently.…”

“…In addition, all included RCT failed to achieve blinding to patients and care providers due to the specialty of this kind of trial. The patients were informed immediately after surgery about the type of surgical procedure they had been underwent, and care providers were aware of which kind of surgery was to be performed during surgery. Almost all the studies described the dropout rate and 2 studies with a follow‐up rate below 70% were considered as having high risk of bias.…”

“…Of all the parameters identified for meta‐analysis, 6 studies compared overall success and NDI success, 7 studies compared neurological success, 3 studies compared radiological success, 7 studies compared NDI score, 5 studies compared neck pain score, 4 studies compared arm pain score , 5 studies compared SF‐36 PCS, 4 studies compared SF‐36 MCS, 8 studies compared any AE, 4 studies compared serious AE, 6 studies compared device/surgery‐related AE and symptomatic ASD, 2 studies compared radiological superior and inferior ASD, 8 studies compared total secondary surgeries and secondary surgeries at the index level, 9 studies compared secondary surgeries at the adjacent level, 2 studies compared work status, 4 studies compared patients’ satisfaction rate, and 2 studies compared patients’ recommendation rate.…”

“…Heterogeneity definitely existed in the included studies. First, various different types of CDA devices were used in the 11 RCT, including Kineflex|C, Bryan, Discover Secure‐C, Prestige, Mobi‐C, ProDisc‐C, and PCM, differing in design and biomechanical properties. Second, the surgical level was different among studies.…”