A RCT comparing 7-year clinical outcomes of one level symptomatic cervical disc disease (SCDD) following ProDisc-C total disc arthroplasty (TDA) versus anterior cervical discectomy and fusion (ACDF)

Abstract

The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.

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].…”

“…The authors found similar clinical outcomes between the Prodisc C (n = 103) and ACDF group (n = 106), however, with lower rates of second surgery observed in the cTDR cohort. Loumeau et al [3] assessed the data from an RCT and compared the results from monosegmental treatments between Prodisc C versus ACDF with 7 years of FU. Revision surgeries had to be carried out in 27% of all cases in the cohort of fusion candidates, 9% thereof at the adjacent segment and 18% at the index segment due to pseudoarthrosis.…”

“…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].…”