scholarly journals A multicentre prospective randomized controlled trial comparing efficacy and safety of ProDisc-C to anterior cervical discectomy and fusion for treatment of symptomatic cervical disc disease

2021 ◽  
Vol 1 ◽  
pp. 100208
Author(s):  
Naresh Kumar ◽  
Wai Poon ◽  
Chun-Kun Park ◽  
Ruey-Mo Lin ◽  
Kyoung-Suok Cho ◽  
...  

2006 ◽  
Vol 4 (1) ◽  
pp. 31-35 ◽  
Author(s):  
Domagoj Coric ◽  
Frederick Finger ◽  
Peggy Boltes

Object The authors report on a prospective randomized controlled multicenter trial in which they compared the clinical outcomes obtained in patients who underwent the placement of a Bryan Cervical Disc System with those obtained in patients who underwent anterior cervical discectomy and fusion (ACDF). In the present study, they evaluated the safety and effectiveness of the artificial disc based on data obtained at a single investigational site. Methods Patients with primary, single-level cervical disc disease producing radiculopathy and/or myelopathy were randomized prospectively to undergo anterior cervical discectomy with either fusion or artificial disc placement. The patients were evaluated with pre- and postoperative serial radiographic studies; the authors also evaluated neck disability indices, visual analog scale scores for pain, 36-Item Short Form Health Survey scores, and neurological status at 1.5, 3, 6, 12, and 24 months. Analysis of the early results obtained in the 33 patients indicated an absence of device-related complications. Preliminary analysis revealed that improvement in all clinical outcome measures was excellent for both treatment groups; however, in patients treated with the artificial cervical disc, motion at the treated level was maintained. Conclusions The preliminary results documented at this investigational site are encouraging. Evaluation of data acquired in the Bryan disc treatment group showed that improvements in the clinical parameters were similar to those in the fusion group. Additionally in the artificial disc–treated group, there was radiographic evidence that motion was maintained. It is theorized that motion preservation may potentially reduce the rate of adjacent-level cervical disc disease that has been documented in patients who undergo ACDF.





2022 ◽  
Author(s):  
Valérie N.E. Schuermans ◽  
Anouk Y.J.M. Smeets ◽  
Toon F.M. Boselie ◽  
Math M.J.J. Candel ◽  
Inez Curfs ◽  
...  

Abstract IntroductionTo date, there is no consensus on which anterior surgical technique is more cost-effective in treating cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multi-level symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). The extent to which kinematics, surgery-induced fusion, natural history and progression of disease play a role in the development of CASP remain unclear. Anterior cervical discectomy with arthroplasty (ACDA) is another treatment option that is thought to reduce the incidence of CASP by preserving motion in the operated segment. While ACDA is often discouraged, as the implant costs are higher while the clinical outcomes are similar to ACDF, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long-term.Methods and analysisIn this randomized controlled trial, patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a healthcare and societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline, and every six months until four years post-surgery.DiscussionHigh-quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking; to date, there are no prospective trials from a societal perspective. Considering the ageing of the population and the rising healthcare costs, there is an urgent need for a solid clinical cost-effectiveness trial addressing this question.





2020 ◽  
pp. 219256822092578
Author(s):  
Aditya Dahapute ◽  
Sandeep Sonone ◽  
Shubhanshu Bhaladhare ◽  
Kuber Sakhare ◽  
Nandan Marathe ◽  
...  

Study Design: Prospective randomized controlled trial. Objective: To study the effect of local steroids in the retropharyngeal space after anterior cervical discectomy and fusion (ACDF) in reducing prevertebral soft-tissue swelling (PSTS) and complications associated with it. Methods: A total of 50 consecutive patients operated with ACDF were double-blinded randomized into 2 groups: steroids (25) and control (25). Triamcinolone in collagen sponge was used in the steroid group and normal saline in gelatin sponge in the control group. Patients’ lateral radiographs were taken on the immediate postoperative day; days 2, 4, and 6; at 2 weeks; and 2 and 6 months postoperatively. The PSTS ratio at C3 to C7 and PSTS index were calculated. Patients were clinically evaluated using the Visual Analogue Scale (VAS) score for odynophagia and radiating pain, modified Japanese Orthopedic Association Score (mJOA), and Neck Disability Index (NDI). Results: PSTS showed a significant reduction in the steroid group as compared with the control group on the immediate postoperative day; days 2, 4, and 6; and at 2 weeks. However, at 2 and 6 months, PSTS remained the same. VAS score for odynophagia also showed a significant difference between the 2 groups on the immediate postoperative day; days 2, 4, and 6; and 2 weeks postoperatively, with no significant difference at the 2- and 6-month follow-up. mJOA and NDI showed no significant difference between the 2 groups at the 2- and 6-month follow-up. Conclusion: Use of retropharyngeal steroids helps in reducing the postoperative odynophagia on a short-term basis without any complication.





Nephrology ◽  
2020 ◽  
Vol 3_2020 ◽  
pp. 31-36
Author(s):  
E.V. Shutov Shutov ◽  
G.V. Kotlyarova Kotlyarova ◽  
K.M. Lysenko Lysenko ◽  
G.V. Ryabinskaya Ryabinskaya ◽  
S.V. Lashutin Lashutin ◽  
...  


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