P4. A clinical and radiographic comparison of the prestige cervical disc system to fusion for the treatment of single level degenerative disease

2003 ◽  
Vol 3 (5) ◽  
pp. 152 ◽  
Author(s):  
Thomas Zdeblick ◽  
J. Brotchi ◽  
S. Gill ◽  
R. Haid ◽  
R. Nelson ◽  
...  
Keyword(s):  
Degenerative Disease ◽  
Cervical Disc ◽  
Single Level ◽  
The Prestige

scholarly journals Long-term Follow-Up Results of Dynamic Cervical Implant in Patients with Cervical Disc Diseases: Compared with Prestige LP

2021 ◽  
Author(s):  
Li Zou ◽  
Hao Liu ◽  
Xin Rong ◽  
XIjiao Liu ◽  
Chen Ding ◽  
...  
Keyword(s):  
Short Form ◽  
Degenerative Disease ◽  
Cervical Disc ◽  
Neural Function ◽  
Cervical Disc Replacement ◽  
Dynamic Cervical Implant ◽  
Functional Spinal Unit ◽  
Flexion Extension ◽  
The Prestige

Background and Study Aims: Prestige LP arthroplasty has been proven to be a safe and effective treatment for patients with cervical disc degenerative disease (DDD). Dynamic Cervical Implant (DCI) has emerged as a novel implantation device for cervical DDD. This study aimed to compare the outcomes of these procedures after 5 years of follow-up in the DCI and Prestige LP groups. Key words: cervical disc degenerative disease; cervical disc replacement; Dynamic Cervical Implant; Prestige LP Materials and Methods: This study retrospectively enrolled 79 consecutive cervical DDD patients with 41 DCI and 47 Prestige LP prostheses implanted. Radiographs were analyzed for intervertebral height and range of motion (ROM). Neural function of the participants was assessed using the Neck Disability Index score, Visual Analog Scale, Japanese Orthopaedic Association score and 36-Item Short Form Survey. Results: The DCI group had statistically lesser flexion/extension and bilateral bending ROM than the Prestige LP group at the operated level(s) (p<0.05). The DCI group showed improved lordotic alignment of C2–C7 and operated functional spinal unit than the Prestige LP group (p<0.05). No statistical difference was observed in the neural function of the two groups. Heterotopic ossification was found in 7 and 14 patients in the DCI and Prestige LP groups, respectively. Conclusion: The 5 years follow-up results were comparable between the two groups. We believe that DCI implantation is a safe and effective procedure and could possibly become an alternative treatment for cervical DDD.

Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial

2007 ◽  
Vol 6 (3) ◽  
pp. 198-209 ◽  
Author(s):  
Praveen V. Mummaneni ◽  
J. Kenneth Burkus ◽  
Regis W. Haid ◽  
Vincent C. Traynelis ◽  
Thomas A. Zdeblick
Keyword(s):  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Control Group ◽  
Adjacent Segment ◽  
Segmental Motion ◽  
Disc Arthroplasty ◽  
Cervical Discectomy ◽  
Single Level ◽  
The Prestige

Object The authors report the results of a prospective randomized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical degenerative disc disease (DDD). Methods Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and randomly assigned to one of two treatment groups: 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System (Medtronic Sofamor Danek); 265 patients in the control group underwent decompressive ACDF. Eighty percent of the arthroplasty-treated patients (223 of 276) and 75% of the control patients (198 of 265) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery. Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group. The arthroplasty group also had a statistically significant higher rate of neurological success (p = 0.005) as well as a lower rate of secondary revision surgeries (p = 0.0277) and supplemental fixation (p = 0.0031). The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months, as was relief of neck pain. The patients in the investigational group returned to work 16 days sooner than those in the control group, and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well (p = 0.0492, log-rank test). The cervical disc implant maintained segmental sagittal angular motion averaging more than 7°. In the investigational group, there were no cases of implant failure or migration. Conclusions The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success, improved clinical outcomes, and a reduced rate of secondary surgeries compared with ACDF.

scholarly journals Cervical arthroplasty: what does the labeling say?

2017 ◽  
Vol 42 (2) ◽  
pp. E2 ◽  
Author(s):  
Mazda K. Turel ◽  
Mena G. Kerolus ◽  
Owoicho Adogwa ◽  
Vincent C. Traynelis
Keyword(s):  
Outcome Measures ◽  
Revision Surgery ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Specific Treatment ◽  
The United States ◽  
Cervical Disc ◽  
Cervical Arthroplasty ◽  
Single Level ◽  
Level Group

OBJECTIVE The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)–approved labels of 7 total cervical disc replacements, assess the exact methodology in which the trial was conducted, and provide a broad comparison of these devices to allow each surgeon to determine which disc best suits his or her specific treatment goals based on the specific labels and not the studies published. METHODS The FDA-approved labels for each of the 7 artificial discs were obtained from the official FDA website. These labels were meticulously compared with regard to the statistical analysis performed, the safety and efficacy data, and the randomized controlled trial that each artificial disc was involved in to obtain the FDA approval for the product or device. Both single-level and 2-level approvals were examined, and primary and secondary end points were assessed. RESULTS In the single-level group, 4 of the 7 artificial discs—Prestige LP, Prestige ST, Bryan, and Secure-C—showed superiority in overall success. Prestige ST showed superiority in 3 of 4 outcome measures (neurological success, revision surgery, and overall success), while the other aforementioned discs showed superiority in 2 or fewer measures (Prestige LP, neurological and overall success; Bryan, Neck Disability Index [NDI] and overall success; Secure-C, revision surgery and overall success; Pro-Disc C, revision surgery). The PCM and Mobi-C discs demonstrated noninferiority across all outcome measures. In the 2-level group, Prestige LP and Mobi-C demonstrated superiority in 3 outcome measures (NDI, secondary surgery, and overall success) but not neurological success. CONCLUSIONS This paper provides a comprehensive analysis of 7 currently approved and distributed artificial discs in the United States. It compares specific outcome measures of these devices against those following the standard of care, which is anterior cervical discectomy and fusion. This information will provide surgeons the opportunity to easily answer patients' questions and remain knowledgeable when discussing devices with manufacturers.

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.

Cost-effectiveness analysis: comparing single-level cervical disc replacement and single-level anterior cervical discectomy and fusion

2013 ◽  
Vol 19 (5) ◽  
pp. 546-554 ◽  
Author(s):  
Sheeraz A. Qureshi ◽  
Steven McAnany ◽  
Vadim Goz ◽  
Steven M. Koehler ◽  
Andrew C. Hecht
Keyword(s):  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Cost Effective ◽  
Anterior Cervical Discectomy ◽  
Disc Replacement ◽  
Cervical Disc ◽  
Reference Case ◽  
Cervical Disc Replacement ◽  
Single Level

Object In recent years, there has been increased interest in the use of cervical disc replacement (CDR) as an alternative to anterior cervical discectomy and fusion (ACDF). While ACDF is a proven intervention for patients with myelopathy or radiculopathy, it does have inherent limitations. Cervical disc replacement was designed to preserve motion, avoid the limitations of fusion, and theoretically allow for a quicker return to activity. A number of recently published systematic reviews and randomized controlled trials have demonstrated positive clinical results for CDR, but no studies have revealed which of the 2 treatment strategies is more cost-effective. The purpose of this study was to evaluate the cost-effectiveness of CDR and ACDF by using the power of decision analysis. Additionally, the authors aimed to identify the most critical factors affecting procedural cost and effectiveness and to define thresholds for durability and function to focus and guide future research. Methods The authors created a surgical decision model for the treatment of single-level cervical disc disease with associated radiculopathy. The literature was reviewed to identify possible outcomes and their likelihood following CDR and ACDF. Health state utility factors were determined from the literature and assigned to each possible outcome, and procedural effectiveness was expressed in units of quality-adjusted life years (QALYs). Using ICD-9 procedure codes and data from the Nationwide Inpatient Sample, the authors calculated the median cost of hospitalization by multiplying hospital charges by the hospital-specific cost-to-charge ratio. Gross physician costs were determined from the mean Medicare reimbursement for each current procedural terminology (CPT) code. Uncertainty as regards both cost and effectiveness numbers was assessed using sensitivity analysis. Results In the reference case, the model assumed a 20-year duration for the CDR prosthesis. Cervical disc replacement led to higher average QALYs gained at a lower cost to society if both strategies survived for 20 years ($3042/QALY for CDR vs $8760/QALY for ACDF). Sensitivity analysis revealed that CDR needed to survive at least 9.75 years to be considered a more cost-effective strategy than ACDF. Cervical disc replacement becomes an acceptable societal strategy as the prosthesis survival time approaches 11 years and the $50,000/QALY gained willingness-to-pay threshold is crossed. Sensitivity analysis also indicated that CDR must provide a utility state of at least 0.796 to be cost-effective. Conclusions Both CDR and ACDF were shown to be cost-effective procedures in the reference case. Results of the sensitivity analysis indicated that CDR must remain functional for at least 14 years to establish greater cost-effectiveness than ACDF. Since the current literature has yet to demonstrate with certainty the actual durability and long-term functionality of CDR, future long-term studies are required to validate the present analysis.

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