scholarly journals Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study

2020 ◽  
Author(s):  
Frank M. Phillips ◽  
Domagoj Coric ◽  
Rick Sasso ◽  
Todd Lanman ◽  
William Lavelle ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Degrees Of Freedom ◽  
Cervical Radiculopathy ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Multicenter Clinical Trial ◽  
Cervical Discectomy ◽  
Six Degrees Of Freedom ◽  
Single Level ◽  
Investigational Device Exemption

Outcomes of single-level cervical disc arthroplasty versus anterior cervical discectomy and fusion

2014 ◽  
Vol 21 (11) ◽  
pp. 1905-1908 ◽  
Author(s):  
Robert W. Tracey ◽  
Daniel G. Kang ◽  
John P. Cody ◽  
Scott C. Wagner ◽  
Michael K. Rosner ◽  
...  
Keyword(s):  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Disc Arthroplasty ◽  
Cervical Discectomy ◽  
Single Level

Does smoking have an impact on fusion rate in single-level anterior cervical discectomy and fusion with allograft and rigid plate fixation?

2013 ◽  
Vol 19 (5) ◽  
pp. 527-531 ◽  
Author(s):  
Myles Luszczyk ◽  
Justin S. Smith ◽  
Jeffrey S. Fischgrund ◽  
Steven C. Ludwig ◽  
Rick C. Sasso ◽  
...  
Keyword(s):  
Plate Fixation ◽  
Fusion Rate ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Cervical Discectomy ◽  
Single Level ◽  
Significant Difference ◽  
Solid Fusion ◽  
Cervical Plate ◽  
Anterior Cervical Plate

Object Although smoking has been shown to negatively affect fusion rates in patients undergoing multilevel fusions of the cervical and lumbar spine, the effect of smoking on fusion rates in patients undergoing single-level anterior cervical discectomy and fusion (ACDF) with allograft and plate fixation has yet to be thoroughly investigated. The objective of the present study was to address the effect of smoking on fusion rates in patients undergoing a 1-level ACDF with allograft and a locked anterior cervical plate. Methods This study is composed of patients from the control groups of 5 separate studies evaluating the use of an anterior cervical disc replacement to treat cervical radiculopathy. For each of the 5 studies the control group consisted of patients who underwent a 1-level ACDF with allograft and a locked cervical plate. The authors of the present study reviewed data obtained in a total of 573 patients; 156 patients were smokers and 417 were nonsmokers. A minimum follow-up period of 24 months was required for inclusion in this study. Fusion status was assessed by independent observers using lateral, neutral, and flexion/extension radiographs. Results An overall fusion rate of 91.4% was achieved in all 573 patients. A solid fusion was shown in 382 patients (91.6%) who were nonsmokers. Among patients who were smokers, 142 (91.0%) had radiographic evidence of a solid fusion. A 2-tailed Fisher exact test revealed a p value of 0.867, indicating no difference in the union rates between smokers and nonsmokers. Conclusions The authors found no statistically significant difference in fusion status between smokers and nonsmokers who underwent a single-level ACDF with allograft and a locked anterior cervical plate. Although the authors do not promote tobacco use, it appears that the use of allograft with a locked cervical plate in single-level ACDF among smokers produces similar fusion rates as it does in their nonsmoking counterparts.

scholarly journals Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion

2020 ◽  
pp. 219256822091488
Author(s):  
Paul M. Arnold ◽  
Alexander R. Vaccaro ◽  
Rick C. Sasso ◽  
Benoit Goulet ◽  
Michael G. Fehlings ◽  
...  
Keyword(s):  
Short Form ◽  
Secondary Analysis ◽  
Neck Disability Index ◽  
Cervical Radiculopathy ◽  
Anterior Cervical Discectomy ◽  
Disc Disease ◽  
Cervical Discectomy ◽  
Single Level ◽  
Arm Pain ◽  
Patients With Diabetes

Study Design: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study. Objective: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. We compared 24-month radiological and clinical outcomes in individuals with and without diabetes undergoing single-level ACDF with either i-FACTOR or local autologous bone. Methods: Between 2006 and 2013, 319 individuals with single-level degenerative disc disease (DDD) and no previous fusion at the index level underwent ACDF. The presence of diabetes determined the 2 cohorts. Data collected included radiological fusion evaluation, neurological outcomes, Neck Disability Index (NDI), Visual Analog Scale (VAS) scores, and the 36-Item Short Form Survey Version 2 (SF-36v2) Physical and Mental component summary scores. Results: There were 35 individuals with diabetes (11.1%; average body mass index [BMI] = 32.99 kg/m2; SD = 5.72) and 284 without (average BMI = 28.32 kg/m2; SD = 5.67). The number of nondiabetic smokers was significantly higher than diabetic smokers: 73 (25.70%) and 3 (8.57%), respectively. Preoperative scores of NDI, VAS arm pain, and SF-36v2 were similar between the diabetic and nondiabetic participants at baseline; however, VAS neck pain differed significantly between the cohorts at baseline ( P = .0089). Maximum improvement for NDI, VAS neck and arm pain, and SF-36v2 PCS and MCS scores was seen at 6 months in both cohorts and remained stable until 24 months. Conclusions: ACDF is effective for cervical radiculopathy in patients with diabetes. Diabetes is not a contraindication for patients requiring single-level surgery for cervical DDD.

Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials

2012 ◽  
Vol 16 (3) ◽  
pp. 216-228 ◽  
Author(s):  
Cheerag D. Upadhyaya ◽  
Jau-Ching Wu ◽  
Gregory Trost ◽  
Regis W. Haid ◽  
Vincent C. Traynelis ◽  
...  
Keyword(s):  
Random Effects ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Adjacent Level ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Single Level ◽  
Investigational Device Exemption ◽  
Time Point

Object There are now 3 randomized, multicenter, US FDA investigational device exemption, industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion (ACDF) for single-level cervical disease with 2 years of follow-up. These 3 studies evaluated the Prestige ST, Bryan, and ProDisc-C artificial discs. The authors analyzed the combined results of these trials. Methods A total of 1213 patients with symptomatic, single-level cervical disc disease were randomized into 2 treatment arms in the 3 randomized trials. Six hundred twenty-one patients received an artificial cervical disc, and 592 patients were treated with ACDF. In the three trials, 94% of the arthroplasty group and 87% of the ACDF group have completed 2 years of follow-up. The authors analyzed the 2-year data from these 3 trials including previously unpublished source data. Statistical analysis was performed with fixed and random effects models. Results The authors' analysis revealed that segmental sagittal motion was preserved with arthroplasty (preoperatively 7.26° and postoperatively 8.14°) at the 2-year time point. The fusion rate for ACDF at 2 years was 95%. The Neck Disability Index, 36-Item Short Form Health Survey Mental, and Physical Component Summaries, neck pain, and arm pain scores were not statistically different between the groups at the 24-month follow-up. The arthroplasty group demonstrated superior results at 24 months in neurological success (RR 0.595, I2 = 0%, p = 0.006). The arthroplasty group had a lower rate of secondary surgeries at the 2-year time point (RR 0.44, I2 = 0%, p = 0.004). At the 2-year time point, the reoperation rate for adjacent-level disease was lower for the arthroplasty group when the authors analyzed the combined data set using a fixed effects model (RR 0.460, I2 = 2.9%, p = 0.030), but this finding was not significant using a random effects model. Adverse event reporting was too heterogeneous between the 3 trials to combine for analysis. Conclusions Both anterior cervical discectomy and fusion as well as arthroplasty demonstrate excellent 2-year surgical results for the treatment of 1-level cervical disc disease with radiculopathy. Arthroplasty is associated with a lower rate of secondary surgery and a higher rate of neurological success at 2 years. Arthroplasty may be associated with a lower rate of adjacent-level disease at 2 years, but further follow-up and analysis are needed to confirm this finding.

scholarly journals Anterior Cervical Discectomy with or without Fusion in Non-traumatic Single level Cervical Disc Disorder: Study of 50 Cases

2018 ◽  
Vol 27 (1) ◽  
pp. 29-35
Author(s):  
Sukriti Das ◽  
Md Mamunur Rashid ◽  
Kanij Fatema Ishrat Zahan ◽  
Samsul Islam Khan
Keyword(s):  
Range Of Motion ◽  
Clinical Results ◽  
Small Degree ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Cervical Discectomy ◽  
Single Level ◽  
Medical College ◽  
Anteroposterior Translation ◽  
Mean Time

Objectives: The aim of this study is to compare patients undergoing single level anterior cervical discectomy without fusion (ACD) versus anterior cervical discectomy with fusion (ACDF). Methods: A retrospective analysis of 50 patients with degenerative cervical spondylosis of them 25 had undergone ACD without fusion and remaining 25 undergone ACDF at either C4-C5, C5- C6 level or at C6-C7 level. Results: The kinematic analysis included the range of motion, intervertebral angulations, anteroposterior translation and disc height assessed for the cervical functional spinal units at the operated level and adjacent levels. At the operated level of C4-C5, C5-C6 and C6-C7, the range of motion and the translation were minimal in the anterior cervical discectomy without fusion (ACD) group, but absent in the cervical discectomy with fusion (ACDF) group. The superior adjacent levels range of motion and the translation were greater in the ACDF group compared with the ACD group. But both groups had almost similar results in term of hospital stay, mean time for improvement and patient satisfaction. Conclusion: The clinical results of anterior cervical discectomy without fusion (ACD) and anterior cervical discectomy with fusion (ACDF) were comparable. In cervical discectomy without fusion, the elastic fibrous intradiscal scar at the operated level allows a small degree of mobility and the adjacent cervical levels are not overstressed. Fusion is not routinely required in single level cervical disc herniation until it is associated with instability, loss of cervical lordosis, hard disc, osteophytic bar and multi-segmental disease. So ACD is a better option in single level cervical disc disorder than ACDF. J Dhaka Medical College, Vol. 27, No.1, April, 2018, Page 29-35

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