scholarly journals Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc

2018 ◽  
Vol 28 (3) ◽  
pp. 252-261 ◽  
Author(s):  
Domagoj Coric ◽  
Richard D. Guyer ◽  
Pierce D. Nunley ◽  
David Musante ◽  
Cameron Carmody ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Total Disc Replacement ◽  
Neck Disability Index ◽  
The United States ◽  
Anterior Cervical Discectomy ◽  
Artificial Disc ◽  
Cervical Discectomy ◽  
Metal On Metal ◽  
Ion Analysis

OBJECTIVESeven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up.METHODSAn FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR.RESULTSA total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but was significantly greater than the preoperative mean value at the 12- and 24-month follow-ups and remained significantly improved through the 60-month period. There were no significant differences between the 2 groups in terms of reoperation/revision surgery or device-/surgery-related adverse events. The serum ion analysis revealed cobalt and chromium levels significantly lower than the levels that merit monitoring.CONCLUSIONSCervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy.Clinical trial registration no.: NCT00374413 (clinicaltrials.gov)

Cervical Total Disc Replacement and Anterior Cervical Discectomy and Fusion: Reoperation Rates, Complications, and Hospital Resource Utilization in 72 688 Patients in the United States

Neurosurgery ◽  
2017 ◽  
Vol 82 (4) ◽  
pp. 441-453 ◽  
Author(s):  
Kavelin Rumalla ◽  
Kyle A Smith ◽  
Paul M Arnold
Keyword(s):  
Risk Factors ◽  
Length Of Stay ◽  
Total Disc Replacement ◽  
Surgical Care ◽  
The United States ◽  
Anterior Cervical Discectomy ◽  
Disc Replacement ◽  
Cervical Discectomy ◽  
Discharge Disposition ◽  
Lower Complication

Abstract BACKGROUND Healthcare readmissions are important causes of increased cost and have profound clinical impact. Thirty-day readmissions in spine surgery have been well documented. However, rates, causes, and outcomes are not well understood outside 30 d. OBJECTIVE To analyze 30- and 90-d readmissions for a retrospective cohort of anterior cervical discectomy and fusions (ACDF) and total disc replacement (TDR) for degenerative cervical conditions. METHODS The Nationwide Readmissions Database approximates 50% of all US hospitalizations with patient identifiers to track patients longitudinally. Patients greater than 18 yr old were identified. Rates of readmission for 30 and 90 d were calculated. Predictor variables, complications, outcomes, and costs were analyzed via univariate and multivariable analyses. RESULTS Between January and September 2013, 72 688 patients were identified. The 30- and 90-d readmission rates were 2.67% and 5.97%, respectively. The most prevalent reason for 30-d readmission was complication of medical/surgical care (20.3%), whereas for 90-d readmission it was degenerative spine etiology (19.2%). Common risk factors for 30- and 90-d readmission included older age, male gender, Medicare/Medicaid, prolonged initial length of stay, and various comorbidities. Unique risk factors for 30- and 90-d readmissions included adverse discharge disposition and mechanical implant-related complications, respectively. When comparing ACDF and TDR, ACDFs were associated with increased 90-d readmissions (6.0% vs 4.3%). The TDR cohort had a shorter length of stay, lower complication rate, and fewer adverse discharge dispositions. CONCLUSION Identification of readmission causes and predictors is important to potentially allow for changes in periperative management. Decreasing readmissions would improve patient outcomes and reduce healthcare costs.

Pseudarthrosis in anterior cervical discectomy and fusion with a self-locking, stand-alone cage filled with hydroxyapatite: a retrospective study with clinical and radiological outcomes of 98 levels with a minimum 2-year follow-up

2020 ◽  
Vol 33 (6) ◽  
pp. 717-726
Author(s):  
Eduardo A. Iunes ◽  
Enrico A. Barletta ◽  
Telmo A. B. Belsuzarri ◽  
Franz J. Onishi ◽  
André Y. Aihara ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Neck Disability Index ◽  
Wilcoxon Test ◽  
Anterior Cervical Discectomy ◽  
Adjacent Level ◽  
Disc Disease ◽  
Cervical Discectomy ◽  
Arm Pain ◽  
Pain Status

OBJECTIVEThe goal of this study was to evaluate the incidence of pseudarthrosis after the treatment of cervical degenerative disc disease (CDDD) with anterior cervical discectomy and fusion (ACDF) in which self-locking, stand-alone intervertebral cages filled with hydroxyapatite were used.METHODSThe authors performed a retrospective cohort study of 49 patients who underwent 1- to 3-level ACDF with self-locking, stand-alone intervertebral cages without plates, with a minimum 2 years of follow-up. The following data were extracted from radiological and clinical charts: age, sex, time and type of pre- and postoperative signs and symptoms, pain status (visual analog scale [VAS]), functional status (Neck Disability Index [NDI]), history of smoking, bone quality (bone densitometry), and complications. Pseudarthrosis was diagnosed by a blinded neuroradiologist using CT scans. Clinical improvement was assessed using pre- and postoperative comparison of VAS and NDI scores. The Wilcoxon test for paired tests was used to evaluate statistical significance using a p value of < 0.05.RESULTSThree patients (6%) developed symptomatic pseudarthrosis requiring reoperation, with only 1 patient showing clinical worsening due to pseudarthrosis, while the other 2 with pseudarthrosis had associated disc disease at an adjacent level. The rate of symptomatic pseudarthrosis according to the number of operated levels was 0% for 1 level, 8.7% (2/23 patients) for 2 levels, and 7.7% (1/13 patients) for 3 levels. The total pseudarthrosis rate (including both symptomatic and asymptomatic patients) was 16.4%. Considering the clinical outcomes, there was a significant improvement of 75.6% in neck pain and 95.7% in arm pain, as well as a 64.9% improvement in NDI scores. Complications were observed in 18.4% of patients, with adjacent-level degenerative disease being the most prevalent at 14.3%.CONCLUSIONSACDF with self-locking, stand-alone cages filled with a hydroxyapatite graft can be used for the surgical treatment of 1- to 3-level CDDD with clinical and radiological outcomes significantly improved after a minimum 2-year follow-up period. Comparative studies are necessary.

P148. A Clinical Comparison of a Cervical Artificial Disc and Anterior Cervical Discectomy and Fusion in a Prospective Randomized Trial: Two-Year Follow-Up

2009 ◽  
Vol 9 (10) ◽  
pp. 190S-191S
Author(s):  
Jeffrey McConnell ◽  
Joseph Marzluff ◽  
Christopher Tomaras ◽  
Ildemaro Volcan ◽  
Allan Goodrich ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Anterior Cervical Discectomy ◽  
Prospective Randomized Trial ◽  
Artificial Disc ◽  
Cervical Discectomy ◽  
Clinical Comparison

scholarly journals Is the improvement of cervical alignment really essential after three-level anterior cervical discectomy and fusion? A minimal 5-year follow-up

2020 ◽  
Author(s):  
Yan Liang ◽  
Shuai Xu ◽  
Guanjie Yu ◽  
Zhenqi Zhu ◽  
Haiying Liu
Keyword(s):  
Japanese Orthopaedic Association ◽  
Neck Disability Index ◽  
Adjacent Segment Degeneration ◽  
Anterior Cervical Discectomy ◽  
Adjacent Segment ◽  
Cervical Discectomy ◽  
Cervical Alignment ◽  
Neck Disability

Abstract Purpose: To identify the importance of sagittal alignment with self-locked stand-alone cage (SSC) and anterior cage-with-plate (ACP) system after 3-level anterior cervical discectomy and fusion (ACDF) on cervical spondylotic myelopathy (CSM) after minimal 5-year follow-up.Methods: 38 patients with SSC system (SSC group) and 26 with ACP system (ACP group) from February 2007 to September 2013 were enrolled. Cervical alignment were C2-7 lordosis (CL), operated-segment CL (OPCL), upper and lower adjacent-segment CL (UCL and LCL) at preoperation (POP), immediate postoperation (IPO) and final follow-up (FFU). Clinical outcomes contained the neck disability index (NDI), the Japanese Orthopaedic Association (JOA) score and adjacent segment degeneration (ASD). Patients were divides into CL improved subgroup (IM subgroup) and non-improved subgroup (NIM subgroup).Results: There were improvements on CL and OPCL in both groups. The change of CL and OPCL larger in ACP group (P<0.05) but UAL and LAL were of no significance. NDI and JOA got improvement in both groups at IPO and FFU while ASD was in no difference between SSC and ACP. A total of 40 patients (18 vs 22) acquired CL improvement with a larger population in ACP group. There were no differences on the rate if ASD, NDI, JOA and their change between IM and NIM subgroup and the change of CL were not correlated with NDI, JOA and their change.Conclusion: SSC and ACP both provide long-term efficacy on OPCL correction with little impact on adjacent segment. The improvement of CL after three-level ACDF seems not so essential.

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

2019 ◽  
Vol 31 (4) ◽  
pp. 508-518 ◽  
Author(s):  
Matthew F. Gornet ◽  
Todd H. Lanman ◽  
J. Kenneth Burkus ◽  
Randall F. Dryer ◽  
Jeffrey R. McConnell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neck Disability Index ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Segmental Motion ◽  
Clinical Trial Registration ◽  
Disc Arthroplasty ◽  
Cervical Discectomy

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)

T1 slope minus cervical lordosis in multilevel anterior cervical discectomy and fusion with or without plate: a mean 6-year follow up

2020 ◽  
Author(s):  
Rile Ge ◽  
Peng Yang ◽  
Xin Liu ◽  
Bingtao Wen
Keyword(s):  
Neck Disability Index ◽  
Anterior Cervical Discectomy ◽  
Adjacent Segment ◽  
Cervical Lordosis ◽  
Sagittal Vertical Axis ◽  
Cervical Discectomy ◽  
Cervical Alignment ◽  
Japanese Orthopedic Association ◽  
T1 Slope

Abstract Purpose Cervical alignment between self-locked cage (SLC) and anterior cage-with-plate (ACP) system was debatable, especially in multilevel anterior cervical discectomy and fusion (ACDF). T1 slope minus C2-C7 cervical lordosis (T1S-CL) was critical for cervical-balance while without identified threshold. Thus the study was to compare sagittal alignment between SLC and ACP on 3-level ACDF and to identify the threshold of T1S-CL in 3-level ACDF. Methods 45 patients of 3-level SLC and 28 cases of 3-level ACP with well-matched demographics were retrospectively enrolled with 6.1-year follow-up. Cervical alignment paramters were CL, C2-C7 sagittal vertical axis (C2-C7 SVA), T1S and T1S-CL, as well as adjacent segment degeneration (ASD), obtained on X-ray. Neck disability index (NDI) and Japanese Orthopedic Association (JOA) score were recorded for evaluating quality of life (QOL). NDI of 20 was difined as the cutoff of QOL. Threshold of T1S-CL was determined by both linear and logistic regression model. Result CL, C2-C7 SVA and T1S were insignificant at baseline and all parameters were indifferent at last (P ˃0.05). CL and T1S improved at last in both groups (P < 0.05). The incidence of ASD was comparable between groups (P ˃0.05). Both groups acquired inprovement on NDI and JOA (P < 0.001). There were close correlation among alignment paramters and between parameters and NDI at final follow-up. C2-C7 SVA was independent risk factor for NDI and two regression models predicted C2-C7 SVA with a cutoff of 29.2 mm, corresponded to the threshold on T1S-CL of 20.7°. Conclusions It is comparable on alignment reconstruction between SLC and ACP system. The cutoff on C2-C7 SVA with 29.2 mm corresponds to a thershold of T1S-CL with 20.7° in multilevel ACDF.

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