Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion

Abstract

1.

Clinical and radiological outcome at 10 years of follow-up after total cervical disc replacement

“…Similar observations were verified in a number of studies, which demonstrated comparable post-operative scores at different long-term observation periods, ranging between 4 and 30 years, and irrespective of the type of prosthesis used [2][3][4][16][17][18][19].…”

“…These findings can, however, no longer be upheld based on the data from current comparative long-term studies, as previously published RCTs demonstrated statistically significantly superior clinical results for the cTDR group in comparison to the patients treated with ACDF [3,4]. As an explanation for these findings, the significantly lower longterm revision rates, especially at the adjacent segment, should be taken into consideration.…”

“…At short term FU, no significant differences can be found between both technologies as long as the same adequate decompression techniques are performed. Numerous studies have demonstrated, however, that both cTDR and ACDF achieved comparatively similar improvements in all clinical outcome parameters [3,4,6,8,9,13,14]. However, a number of studies demonstrated that at short-and mid-term FU, the rates of post-operative revision surgeries were significantly lower and in favour of cTDR [1,3,5,15].…”

“…Clinical studies have demonstrated this procedure to be a viable treatment alternative to the gold standard anterior cervical discectomy and fusion (ACDF) [1][2][3][4][5][6][7][8][9].…”

CORR Insights®: Reoperation After Cervical Disc Arthroplasty Versus Anterior Cervical Discectomy and Fusion: A Meta-analysis

“…A meta-analysis can help detemine whether this aspiration will come to fruition. A number of intermediate-term trials [5][6][7][8][9][10] have suggested an increased rate of reoperation and poor health-related quality of life outcomes with anterior cervical discectomy and fusion when compared to cervical disc replacement. However, these findings have not been consistent.…”