180 Long-Term Outcomes of Arthroplasty for Cervical Myelopathy Versus Radiculopathy, and Arthroplasty Versus Arthrodesis for Cervical Myelopathy

Neurosurgery ◽  
2017 ◽  
Vol 64 (CN_suppl_1) ◽  
pp. 247-247
Author(s):  
Jeffrey McConnell ◽  
Matthew F Gornet ◽  
K Daniel Riew ◽  
Todd H Lanman ◽  
J Kenneth Burkus ◽  
...  
Keyword(s):  
Neck Pain ◽  
Cervical Myelopathy ◽  
Neurological Status ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Disc Disease ◽  
Arm Pain ◽  
Similar Improvement ◽  
Sf 36

Abstract INTRODUCTION Cervical disc arthroplasty (CDA) is an effective treatment for symptomatic cervical disc disease (SCDD). Concerns remain about the appropriateness of CDA to treat patients with myelopathy. This study compares long-term safety and effectiveness of CDA in patients with myelopathy versus radiculopathy. METHODS Retrospective analysis of prospective 84-month data from IDE clinical trial of CDA vs ACDF for SCDD at 2 adjacent levels: NDI, neck/arm pain, SF-36 PCS, neurological status, adverse events (AEs), secondary surgeries at index and adjacent levels. A total of 397 patients were enrolled: 287 radiculopathy alone and 110 myelopathy +/− radiculopathy. Two comparisons were performed: 1)CDA for myelopathy vs radiculopathy. 2)CDA vs ACDF for myelopathy. RESULTS >All groups significantly improved for NDI, neck/arm pain, and PCS at 84 months. Comparison#1: Myelopathy and radiculopathy groups showed similar improvement for NDI (37.8 vs 35.8, P = 0.352), neck pain (12.0 vs 12.1, P = 0.477), arm pain (11.6 vs 9.6, P = 0.480), and PCS (14.1 vs 13.7, P = 0.863). Both groups had similar maintenance or improvement in neurological status (87.2% vs 93.5%, P = 0.218), serious AEs (54.5% vs 57.5%, P = 0.291) secondary surgeries at index (3.7% vs 4.4%, P = 0.839) and adjacent levels (3.7% vs 7.6%, P = 0.367). Comparison#2: The CDA and ACDF groups showed similar improvement for NDI (37.8 vs 31.1, P = 0.147), neck pain (12.0 vs 10.4, P = 0.337), arm pain (11.6 vs 11.4, P = 0.791) and PCS (14.1 vs 11.2, P = 0.363). Both groups had similar maintenance or improvement in neurological status (87.2% vs 96.2%, P = 0.409) and similar rates of secondary surgeries at the index (3.7% vs 9.4%, P = 0.374) and lower rates of surgeries at adjacent levels (3.7% vs 15.4%, P = 0.088). Compared to ACDF, CDA group demonstrated lower rates of serious AEs (54.5% vs 65.9%, P = 0.019). CONCLUSION Long-term, CDA is safe and effective for the treatment of myelopathy. Myelopathy patients gain similar improvement from CDA to patients with radiculopathy only. Furthermore, myelopathy patients report similar levels of improvement from CDA compared with ACDF, but suffer fewer serious AEs

174 Comparison of 7-Year Results of One-Level versus Two-Level Cervical Disc Arthroplasty and Fusion

Neurosurgery ◽  
2017 ◽  
Vol 64 (CN_suppl_1) ◽  
pp. 245-245
Author(s):  
Todd H Lanman
Keyword(s):  
Clinical Trials ◽  
Neck Pain ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Propensity Score Method ◽  
Disc Disease ◽  
Disc Arthroplasty ◽  
Arm Pain ◽  
Sf 36 ◽  
Level Versus

Abstract INTRODUCTION Two independent clinical trials concluded that cervical disc arthroplasty (CDA) is as safe and effective as anterior cervical discectomy and fusion (ACDF) for treating cervical disc disease (CDD) at one and two levels. This study compared the safety and effectiveness at 7-year follow-up for subjects treated with CDA versus ACDF at 1 and 2-levels. METHODS Retrospective analysis of combined data from 1 and 2-level FDA IDE clinical trials. Outcomes were compared between 1-level and 2-level CDA and ACDF subjects. Propensity score method was used for an adjusted means analysis. RESULTS >There were no preoperative differences between 1 and 2-level CDA and ACDF patients for NDI, neck/arm pain, and SF-36 PCS. Comparing 1 vs 2-level CDA: there were no differences between 1 and 2-level CDA for NDI improvement (38.2 vs 39.0, P = 0.768), neck pain (11.7 vs 12.3, P = 0.374), arm pain (11.3 vs 11.0, P = 0.736), SF-36 PCS (12.6 vs 14.5, P = 0.220), or rates of neurological success (92.8% vs 91.6%, P = 0.867). Secondary surgeries were numerically higher for 1-than 2-level CDA at index and adjacent levels (7.3% vs 4.2%, P = 0.566) and (11.6% vs 6.5%, P = 0.056) respectively. Rates of serious AEs were significantly higher for 1 than 2-level CDA (67.8% vs 56.7%, P = 0.004). Comparison of 1 vs 2-level ACDF: there were no differences between 1 and 2-level ACDF for NDI improvement (31.1 vs 31.6, P = 0.859), neck pain (9.7 vs 9.9, P = 0.796), arm pain (9.9 vs 10.1, P = 0.848), SF-36 PCS (10.8 vs 12.1, P = 0.424), rates of neurological success (79.7% vs 82.1%, P = 0.421), or rates of secondary surgeries at index levels (13.6% vs 14.7%, P = 0.631) or adjacent levels (10.9% vs 12.5%, P = 0.366). Rates of serious AEs were similar for 1 and 2-level ACDF (61.8% vs 68.2%, P = 0.200) but rates of all AEs (94.5% vs 98.2%, P < 0.001) and device-related AEs (18.9% vs. 27.7%, P = 0.036) were significantly lower for 1 versus 2-level ACDF. CONCLUSION One and 2-level CDA appear to be equally safe and effective in the treatment of CDD at 7-years. Two-level ACDF was equally effective as 1-level, but 2-level ACDF had a higher rate of device-related AEs.

scholarly journals P.229 Epidemiology and Outcomes of Neck Pain Following Surgery for Degenerative Cervical Radiculopathy

2021 ◽  
Vol 48 (s3) ◽  
pp. S86-S86
Author(s):  
MA MacLean ◽  
A Dakson ◽  
F Xavier ◽  
SD Christie ◽  
C Investigators
Keyword(s):  
Neck Pain ◽  
Short Form ◽  
Neck Disability Index ◽  
Cervical Radiculopathy ◽  
Research Network ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Arm Pain ◽  
Composite Scale ◽  
Neck Disability

Background: Many studies have demonstrated improved arm pain (AP) following surgery for degenerative cervical radiculopathy (DCR); however, axial neck pain (NP) is generally not felt to improve. The purpose of this study was to determine whether surgery for DCR improves NP. Methods: A ambispective cohort study of the Canadian Spine Outcomes Research Network (CSORN) registry for patients who received 1-level, 2-level, 3-level ADCF (anterior cervical discectomy and fusion) or cervical disc arthroplasty (CDA) for DCR. Outcomes: 12-month post-operative Visual Analogue Scale for NP (VAS-NP), Neck Disability Index (NDI), VAS for AP (VAS-AP), Short-Form Physical Health Composite Scale (SF36-PCS), and Mental Health Composite Scale (SF36-MCS). Results: We identified 603 patients with DCR. CDA patients were the youngest (ANOVA; p<0.001). Patients reported similar pre-operative AP, NP, disability, and health-related quality of life, regardless of procedure (ANOVA; all P>0.05). All procedures offered a statistically significant reduction in VAS-NP, VAS-AP, and NDI (ANOVA; all P<0.001). Mean change from baseline in NP, AP, and disability, were similar across procedures. At 12 months, mean reduction in VAS-AP, VAS-NP, and NDI exceeded minimal clinically important differences for nearly all procedures. Conclusions: Patients undergoing surgery for DCR can expect a clinically significant, approximate 50% reduction in NP, AP, and neck-related disability.

Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial

Neurosurgery ◽  
2020 ◽  
Author(s):  
Kee Kim ◽  
Greg Hoffman ◽  
Hyun Bae ◽  
Andy Redmond ◽  
Michael Hisey ◽  
...  
Keyword(s):  
Neck Disability Index ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Adjacent Segment ◽  
Disc Disease ◽  
Cervical Arthroplasty ◽  
Disc Arthroplasty ◽  
Arm Pain ◽  
Pain Outcomes ◽  
Neck Disability

Abstract BACKGROUND Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. OBJECTIVE To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. METHODS This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. RESULTS At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. CONCLUSION Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.

scholarly journals Delayed periprosthetic collection after cervical disc arthroplasty

2020 ◽  
Vol 32 (4) ◽  
pp. 584-591
Author(s):  
Lauren Harris ◽  
Edward Dyson ◽  
Matthew Elliot ◽  
David Peterson ◽  
Christian Ulbricht ◽  
...  
Keyword(s):  
Case Series ◽  
Delayed Type Hypersensitivity ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Failure Rates ◽  
Body Type ◽  
Disc Disease ◽  
Disc Arthroplasty ◽  
Cervical Disc Replacement

Cervical disc arthroplasty is a treatment option for symptomatic cervical disc disease. There is a paucity of literature on long-term safety outcomes, durability, and device-related failure rates. The M6-C artificial cervical disc is a device with titanium alloy endplates and a complex polymeric centerpiece. To date, trials have exhibited acceptable safety profiles.This case series describes the presentation, management, and pathological findings of a delayed prevertebral periprosthetic mass anterior to the M6-C disc. Four patients at 3 different institutions underwent cervical disc replacement with the M6-C disc. Two to seven years postoperatively, they presented with dysphagia secondary to a compressive mass anterior to the disc. Case notes were reviewed to collect data on symptoms, management, and outcomes. The patients were systemically well and presented with progressive dysphagia. They had imaging findings of a mass anterior to the disc. They underwent a decompressive procedure, with 2 patients undergoing device removal and fusion. In 2 cases, a soft-tissue mass was seen intraoperatively, with frank pus. In 3 cases, Propionibacterium acnes was identified and antibiotic treatment given. Histopathology demonstrated mixed inflammatory infiltrates with foreign body–type granulomas. Postoperatively, the dysphagia resolved.The development of delayed dysphagia in a patient with an M6-C disc should prompt investigation to identify a mass lesion. To the authors’ knowledge, this is the first report of delayed infection, or suspected delayed-type hypersensitivity reaction, following M6-C disc implantation. It is important for this to be added to the device safety concerns. Further prospective studies are needed to establish the incidence and the long-term safety and failure rates of the M6-C disc.

scholarly journals Cervical disc arthroplasty at C2–3: illustrative case

2021 ◽  
Vol 2 (5) ◽  
Author(s):  
Jason Ku ◽  
Johnson Ku ◽  
Hsuan-Kan Chang ◽  
Jau-Ching Wu
Keyword(s):  
Disc Herniation ◽  
Magnetic Resonance Images ◽  
Disc Replacement ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Illustrative Case ◽  
Viable Option ◽  
Disc Disease ◽  
Disc Arthroplasty ◽  
Arm Pain

BACKGROUND Since the beginning of the 21st century, cervical disc arthroplasty (CDA) has been accepted as an alternative to anterior cervical discectomy and fusion for surgical management of disc problems. The published clinical trials of CDA have included patients with radiculopathy or myelopathy caused by one- or two-level disc herniation at C3–7. However, it remains uncertain whether CDA is a viable option for C2–3 disc herniation. OBSERVATIONS In this report, a 52-year-old man presented with hand numbness, arm pain, and myelopathic symptoms that were refractory to medical treatment for more than 6 months. The magnetic resonance images demonstrated herniated discs at C2–3, C3–4, and C4–5, causing stenosis. There was no ossification of posterior longitudinal ligament and the spine was mobile, so he received anterior discectomies with artificial disc replacement at each of the C2–3, C3–4, and C4–5 levels. The surgery went smoothly, and his neurological symptoms were promptly relieved. The postoperative radiographs at 24 months demonstrated a preserved range of motion at each level. LESSONS To date, this was the first report of CDA performed at C2–3, which also involved three consecutive levels of disc replacement. The report suggested that both C2–3 and three-consecutive-level CDA may be a viable option for cervical disc disease.

scholarly journals Clinical Course of Cervical Percutaneous Epidural Neuroplasty in Single-Level Cervical Disc Disease with 12-Month Follow-up

2017 ◽  
Vol 6 (20;6) ◽  
pp. E941-E949
Author(s):  
Dong Ah Shin
Keyword(s):  
Neck Pain ◽  
Clinical Course ◽  
Cervical Disc ◽  
Control Group ◽  
Consecutive Series ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Single Level ◽  
Arm Pain

Background: Cervical disc disease is a common and occasionally disabling condition, occurring as a natural consequence of aging in the vast majority of the adult population. Percutaneous epidural neuroplasty (PEN) has been used to deliver highly concentrated drugs for chronic neck pain and to prevent scarring in cases refractory to conventional epidural blocks. However, the clinical course after PEN in cervical disc disease is not well-documented. Objective: The purpose of this study was to evaluate the efficacy of cervical PEN for single-level cervical disc disease. Study Design: A retrospective observational study. Methods: A consecutive series of 100 patients who underwent cervical PEN for single-level disc disease (bulging or protrusion) were included in this study. Preoperatively, all patients underwent magnetic resonance imaging (MRI), and visual analog scale (VAS) scores as well as Odom’s criteria were measured preoperatively and at post-operative follow-up visits (one, 3, 6, and 12 months). Limitations: The results of this study are limited by the lack of a control group that did not undergo treatment with PEN. Results: Additional block therapy was performed in 58 patients (58.0%). Subsequent surgery was performed in 10 patients (10.0%, excluded from data of clinical follow-up). Mean neck pain and VAS arm pain scores for all follow-up patients decreased from 6.82 and 4.74 preoperatively to 2.18 and 1.87 at 12 months after PEN (P < 0.001). More than 80% and 40% of all patients with and without additional block therapy after cervical PEN, respectively, showed good and excellent outcomes according to Odom’s Criteria during 12 months of follow-up. During this follow-up period, no severe complications related to the procedure were observed. Conclusion: Cervical PEN was shown to be a safe and effective treatment for neck and arm pain in single-level disc disease during 12 months of follow-up.

scholarly journals Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study

2015 ◽  
Vol 23 (5) ◽  
pp. 558-573 ◽  
Author(s):  
Matthew F. Gornet ◽  
J. Kenneth Burkus ◽  
Mark E. Shaffrey ◽  
Perry J. Argires ◽  
Hui Nian ◽  
...  
Keyword(s):  
Propensity Score ◽  
Neurological Status ◽  
Historical Control ◽  
Bayesian Probability ◽  
Cervical Disc ◽  
Work Status ◽  
Control Group ◽  
Arm Pain ◽  
Sf 36 ◽  
The Mean

OBJECT This study compared the safety and efficacy of treatment with the PRESTIGE LP cervical disc versus a historical control anterior cervical discectomy and fusion (ACDF). METHODS Prospectively collected PRESTIGE LP data from 20 investigational sites were compared with data from 265 historical control ACDF patients in the initial PRESTIGE Cervical Disc IDE study. The 280 investigational patients with single-level cervical disc disease with radiculopathy and/or myelopathy underwent arthroplasty with a low-profile artificial disc. Key safety/efficacy outcomes included Neck Disability Index (NDI), Neck and Arm Pain Numerical Rating Scale scores, 36-Item Short Form Health Survey (SF-36) score, work status, disc height, range of motion, adverse events (AEs), additional surgeries, and neurological status. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Predefined Bayesian statistical methods with noninformative priors were used, along with the propensity score technique for controlling confounding factors. Analysis by independent statisticians confirmed initial statistical findings. RESULTS The investigational and control groups were mostly similar demographically. There was no significant difference in blood loss (51.0 ml [investigational] vs 57.1 ml [control]) or hospital stay (0.98 days [investigational] vs 0.95 days [control]). The investigational group had a significantly longer operative time (1.49 hours vs 1.38 hours); 95% Bayesian credible interval of the difference was 0.01–0.21 hours. Significant improvements versus preoperative in NDI, neck/arm pain, SF-36, and neurological status were achieved by 1.5 months in both groups and were sustained at 24 months. Patient follow-up at 24 months was 97.1% for the investigational group and 84.0% for the control group. The mean NDI score improvements versus preoperative exceeded 30 points in both groups at 12 and 24 months. SF-36 Mental Component Summary superiority was established (Bayesian probability 0.993). The mean SF-36 PCS scores improved by 14.3 points in the investigational group and by 11.9 points in the control group from baseline to 24 months postoperatively. Neurological success at 24 months was 93.5% in the investigational group and 83.5% in the control group (probability of superiority ~ 1.00). At 24 months, 12.1% of investigational and 15.5% of control patients had an AE classified as device or device/surgical procedure related; 14 (5.0%) investigational and 21 (7.9%) control patients had a second surgery at the index level. The median return-to-work time for the investigational group was 40 days compared with 60 days for the control group (p = 0.020 after adjusting for preoperative work status and propensity score). Following implantation of the PRESTIGE LP device, the mean angular motion was maintained at 12 months (7.9°) and 24 months (7.5°). At 24 months, 90.0% of investigational and 87.7% of control patients were satisfied with the results of surgery. PRESTIGE LP superiority on overall success (without disc height success), a composite safety/efficacy end point, was strongly supported with 0.994 Bayesian probability. CONCLUSIONS This device maintains mean postoperative segmental motion while providing the potential for biomechanical stability. Investigational patients reported significantly improved clinical outcomes compared with baseline, at least noninferior to ACDF, up to 24 months after surgery.

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