One-Year NDI and VAS Outcomes from the Single-Level PEEK-on-Ceramic SimplifyTM Disc FDA IDE Trial

Ceramics in total disc replacements: A scoping review

“…NDI scores of patients who received TDR were significantly lower, i.e. superior (Geisler et al, 2019;Gornet et al, 2019b;Guyer et al, 2021;Phillips et al, 2013) or not statistically different (Shi et al, 2016), when compared to fusion outcomes.…”

“…Reported rates of secondary surgeries following treatment with ceramic TDR were in the range from <1% (1/148) at 1 y. p.o. (Geisler et al, 2019) to 10.3% at 10 y. p.o. (Gornet et al, 2019a).…”

“…Reported patient outcomes following treatment with cervical ceramic TDRs were found to be significantly better than after fusion when evaluated as the overall treatment success (Gornet et al, 2019b;Phillips et al, 2013;Guyer et al, 2021), and comparable (Shi et al, 2016) or better (Geisler et al, 2019;Gornet et al, 2019b;Phillips et al, 2013;Guyer et al, 2021) when evaluated using NDI. This is in line with the literature, as significantly more favorable treatment outcomes (Findlay et al, 2018;Hu et al, 2016;Cai et al, 2020) and lower NDI values (Zhang et al, 2015) were reported for cervical TDRs when compared to fusion in previous meta-analyses of randomized controlled trials.…”

“…There are inter-study methodological variations in the reporting of pain scores: (Enan et al, 2011;Phillips et al, 2013;Ramadan et al, 2007) used a simple VAS scale from 0 mm-100 mm, (Gornet et al, 2019a) used a numeric scale and multiplied duration (0− 10) with intensity (0-10) for neck and arm pain, whereas (Gornet et al, 2019b) used numeric ratings based on frequency and intensity. Others did not report arm and neck pain separately but used a single value for both (Choi et al, 2012;Geisler et al, 2019;Guyer et al, 2021) or only improvement (Pimenta et al, 2007).…”