scholarly journals Adjacent Segment Pathology After Treatment With Cervical Disc Arthroplasty or Anterior Cervical Discectomy and Fusion, Part 1: Radiographic Results at 7-Year Follow-Up

10.14444/7036 ◽  
2020 ◽  
Vol 14 (3) ◽  
pp. 269-277 ◽  
Author(s):  
PIERCE D. NUNLEY ◽  
EUBULUS J. KERR ◽  
DAVID A. CAVANAUGH ◽  
PHILLIP ANDREW UTTER ◽  
PETER G. CAMPBELL ◽  
...  
Keyword(s):  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Adjacent Segment ◽  
Disc Arthroplasty ◽  
Cervical Discectomy

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 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)

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