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

Lanman, Todd H.; Burkus, J. Kenneth; Dryer, Randall G.; Gornet, Matthew F.; McConnell, Jeffrey R.; Hodges, Scott D.

doi:10.3171/2016.11.spine16746

Cited by 90 publications

(49 citation statements)

References 22 publications

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“…The specific methods and procedures for this clinical trial have been described in detail elsewhere, including inclusion and exclusion criteria and detailed definitions of all outcome measures. 11,15 Key components of the research protocol are summarized below.…”

Section: Methodsmentioning

confidence: 99%

“…A postapproval study (PAS) with patient follow-up to 10 years was required by the FDA, and 7-year follow-up results have been reported. 15 Those results continued to show the noninferiority of CDA compared to ACDF as well as superiority in overall success and other measures.…”

mentioning

confidence: 88%

“…A lthough anterior cervical discectomy and fusion (ACDF) is the standard surgical treatment for cervical degenerative disc disease (DDD) associated with radiculopathy and myelopathy, clinical studies have demonstrated the safety and efficacy of total cervical disc replacements, variously referred to as total disc replacement (TDR), cervical total disc replacement (cTDR), cervical disc replacement (CDR), cervical disc arthroplasty (CDA), and artificial disc replacement (ADR), for both one-and two-level disease. [2][3][4][5]7,[10][11][12]15,20,21,24,25,27 These studies used ACDF as the control group/standard treatment against which to assess noninferiority and potential superiority of CDA.…”

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confidence: 99%

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

Gornet

Lanman

Burkus³

et al. 2019

Journal of Neurosurgery: Spine

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102

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OBJECTIVEThe 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).METHODSA 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.RESULTSFrom 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%).CONCLUSIONSThe 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)

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Section: Methodsmentioning

confidence: 99%

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confidence: 88%

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confidence: 99%

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

Gornet

Lanman

Burkus³

et al. 2019

Journal of Neurosurgery: Spine

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102

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“…Neurological success was reported in six studies [16][17][18][19][20][21] that comprised 944 patients in the CDA group and 747 patients in the ACDF group. The pooled results indicated that the neurological success rate in the CDA group was significantly higher than that in the ACDF group (OR = 1.54, 95% confidence interval [CI]: 1.14-2.08, p = 0.004) with moderate heterogeneity (I 2 = 34.0%, p = 0.18) ( Fig.…”

Section: Meta-analysis Outcomementioning

confidence: 99%

Comparison of cervical disc arthroplasty and anterior cervical discectomy and fusion for the treatment of cervical disc degenerative diseases on the basis of more than 60 months of follow-up: a systematic review and meta-analysis

Zhang

et al. 2020

BMC Neurol

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Background: This meta-analysis was designed to investigate the long-term efficacy and safety between cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) in treating cervical disc degenerative diseases (CDDDs). Methods: Literature search was performed on Pubmed, Embase, Cochrane Library, and Web of Science before Jan 2019. Surgical details, clinical outcomes, range of motion (ROM), complications, and reoperation rates between CDA and ACDF groups were compared and analyzed. A fixed-or random-effects model was applied based on different heterogeneity. STATA (Version 11.0) software was used to perform data analysis. Results: A total of 13 randomized controlled trial studies with more than 60 months of follow-up (mean 83.1 months) were enrolled in this meta-analysis. Pool results indicated that the CDA group exhibited significantly better outcomes in clinical scores (odds ratio [OR] = 1.54, 95% confidence interval [CI]: 1.15-2.08, p = 0.004) and preservation of ROM (mean difference = 1.77, 95% CI: 1.60-1.95, p < 0.001) than the ACDF group. Meanwhile, the incidence of adjacent segment disease (ASD) (OR = 0.51, 95% CI: 0.35-0.76, p = 0.001) and occurrence of reoperation (OR = 0.41, 95% CI: 0.25-0.69, p = 0.001) were lower in the CDA group than in the ACDF group.

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“…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.…”

Section: Resultsmentioning

confidence: 99%

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

Wang

et al. 2019

Orthopaedic Surgery

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Objective Whether cervical disc arthroplasty (CDA) is superior to anterior cervical discectomy and fusion (ACDF) remains controversial, especially in relation to long‐term results. The present study aimed to evaluate the long‐term safety and efficiency of CDA and ACDF for cervical disc disease. Methods We performed this study according to the Cochrane methodology. An extensive search was undertaken in PubMed, Embase, and Cochrane databases up to 1 June 2019 using the following key words: “anterior cervical fusion,” “arthroplasty,” “replacement” and “artificial disc”. RevMan 5.3 (Cochrane, London, UK) was used to analyze data. Safety and efficiency outcome measures included the success rate, functional outcome measures, adverse events (AE), adjacent segment degeneration (ASD), secondary surgery, and patients’ satisfaction and recommendation rates. The OR and MD with 95% confidence interval (CI) were used to evaluate discontinuous and continuous variables, respectively. The statistically significant level was set at P < 0.05. Results A total of 11 randomized controlled trials with 3505 patients (CDA/ACDF: 1913/1592) were included in this meta‐analysis. Compared with ACDF, CDA achieved significantly higher overall success (2.10, 95% CI [1.70, 2.59]), neck disability index (NDI) success (1.73, 95% CI [1.37, 2.18]), neurological success (1.65, 95% CI [1.24, 2.20]), patients’ satisfaction (2.14, 95% CI [1.50, 3.05]), and patients’ recommendation rates (3.23, 95% CI [1.79, 5.80]). Functional outcome measures such as visual analog score neck pain (−5.50, 95% CI [−8.49, −2.52]) and arm pain (−3.78, 95% CI [−7.04, −0.53]), the Short Form‐36 physical component score (SF‐36 PCS) (1.93, 95% CI [0.53, 3.32]), and the Short Form‐36 mental component score (SF‐36 MCS) (2.62, 95% CI [0.95, 4.29]), revealed superiority in the CDA group. CDA also achieved a significantly lower rate of symptomatic ASD (0.46, 95% CI [0.34, 0.63]), total secondary surgery (0.50, 95% CI [0.29, 0.87]), secondary surgery at the index level (0.46, 95% CI [0.29, 0.74]), and secondary surgery at the adjacent level (0.37, 95% CI [0.28, 0.49]). However, no significant difference was found in radiological success (1.35, 95% CI [0.88, 2.08]), NDI score (−2.88, 95% CI [−5.93, 0.17]), total reported AE (1.14, 95% CI [0.92, 1.42]), serious AE (0.89, 95% CI [0.71, 1.11]), device/surgery‐related AE (0.90, 95% CI [0.68, 1.18]), radiological superior ASD (0.63, 95% CI [0.28, 1.43]), inferior ASD (0.45, 95% CI [0.19, 1.11]), and work status (1.33, 95% CI [0.78, 2.25]). Furthermore, subgroup analysis showed different results between US and non‐US groups. Conclusion Our study provided further evidence that compared to ACDF, CDA had a higher long‐term clinical success rate and better functional outcome measurements, and resulted in less symptomatic ASD and fewer secondary surgeries. However, worldwide multicenter RCT with long‐term follow up are still needed for further evaluation in the future.

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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

Cited by 90 publications

References 22 publications

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

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

Comparison of cervical disc arthroplasty and anterior cervical discectomy and fusion for the treatment of cervical disc degenerative diseases on the basis of more than 60 months of follow-up: a systematic review and meta-analysis

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

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