scholarly journals Long-Term Clinical Experience with Selectively Constrained SECURE-C Cervical Artificial Disc for 1-Level Cervical Disc Disease: Results from Seven-Year Follow-Up of a Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial

10.14444/5044 ◽  
2018 ◽  
Vol 12 (3) ◽  
pp. 377-387 ◽  
Author(s):  
ALEXANDER VACCARO ◽  
WILLIAM BEUTLER ◽  
WALTER PEPPELMAN ◽  
JOSEPH MARZLUFF ◽  
ANDREW MUGGLIN ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Experience ◽  
Cervical Disc ◽  
Artificial Disc ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Randomized Controlled ◽  
Investigational Device Exemption

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 The authors analyzed the 2-year data from these 3 trials including previously unpublished source data.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.

Prospective randomized controlled study of the Bryan Cervical Disc: early clinical results from a single investigational site

2006 ◽  
Vol 4 (1) ◽  
pp. 31-35 ◽  
Author(s):  
Domagoj Coric ◽  
Frederick Finger ◽  
Peggy Boltes
Keyword(s):  
Short Form ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Controlled Study ◽  
Artificial Disc ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Cervical Discectomy ◽  
Randomized Controlled ◽  
Bryan Disc

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.

Prospective long-term longitudinal radiographic follow-up after treatment of cervical disc disease with the Bryan cervical disc prosthesis

2009 ◽  
Vol 72 (5) ◽  
pp. 515
Author(s):  
J. Walraevens ◽  
J. Vander Sloten ◽  
P. Demaerel ◽  
P. Suetens ◽  
J. van Loon ◽  
...  
Keyword(s):  
Cervical Disc ◽  
Disc Prosthesis ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Cervical Disc Prosthesis

scholarly journals Adjacent-level arthroplasty following cervical fusion

2017 ◽  
Vol 42 (2) ◽  
pp. E5 ◽  
Author(s):  
Deshpande V. Rajakumar ◽  
Akshay Hari ◽  
Murali Krishna ◽  
Subhas Konar ◽  
Ankit Sharma
Keyword(s):  
Cobb Angle ◽  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Cervical Fusion ◽  
Adjacent Level ◽  
Cervical Disc Disease ◽  
Disc Disease ◽  
Cervical Arthroplasty ◽  
Arm Pain

OBJECTIVE Adjacent-level disc degeneration following cervical fusion has been well reported. This condition poses a major treatment dilemma when it becomes symptomatic. The potential application of cervical arthroplasty to preserve motion in the affected segment is not well documented, with few studies in the literature. The authors present their initial experience of analyzing clinical and radiological results in such patients who were treated with arthroplasty for new or persistent arm and/or neck symptoms related to neural compression due to adjacent-segment disease after anterior cervical discectomy and fusion (ACDF). METHODS During a 5-year period, 11 patients who had undergone ACDF anterior cervical discectomy and fusion (ACDF) and subsequently developed recurrent neck or arm pain related to adjacent-level cervical disc disease were treated with cervical arthroplasty at the authors' institution. A total of 15 devices were implanted (range of treated levels per patient: 1–3). Clinical evaluation was performed both before and after surgery, using a visual analog scale (VAS) for pain and the Neck Disability Index (NDI). Radiological outcomes were analyzed using pre- and postoperative flexion/extension lateral radiographs measuring Cobb angle (overall C2–7 sagittal alignment), functional spinal unit (FSU) angle, and range of motion (ROM). RESULTS There were no major perioperative complications or device-related failures. Statistically significant results, obtained in all cases, were reflected by an improvement in VAS scores for neck/arm pain and NDI scores for neck pain. Radiologically, statistically significant increases in the overall lordosis (as measured by Cobb angle) and ROM at the treated disc level were observed. Three patients were lost to follow-up within the first year after arthroplasty. In the remaining 8 cases, the duration of follow-up ranged from 1 to 3 years. None of these 8 patients required surgery for the same vertebral level during the follow-up period. CONCLUSIONS Artificial cervical disc replacement in patients who have previously undergone cervical fusion surgery appears to be safe, with encouraging early clinical results based on this small case series, but more data from larger numbers of patients with long-term follow-up are needed. Arthroplasty may provide an additional tool for the management of post-fusion adjacent-level cervical disc disease in carefully selected patients.

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