Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc

Abstract

<jats:p content-type="fine-print"><jats:italic>Object.</jats:italic> Arthrodesis is the gold standard for surgical treatment of lumbar degenerative disc disease (DDD). Solid fusion, however, can cause stress and increased motion in the segments adjacent to the fused level. This may initiate and/or accelerate the adjacent-segment disease process. Artificial discs are designed to restore and maintain normal motion of the lumbar intervertebral segment. Restoring and maintaining normal motion of the segment reduces stresses and loads on adjacent level segments. A US Food and Drug Administration Investigational Device Exemptions multicentered study of the Charité artificial disc was completed. The control group consisted of individuals who underwent anterior lumbar interbody fusion involving BAK cages and iliac crest bone graft. This is the first report of Class I data in which a lumbar artificial disc is compared with lumbar fusion.</jats:p> <jats:p content-type="fine-print"><jats:italic>Methods.</jats:italic> Of 304 individuals enrolled in the study, 205 were randomized to the Charité disc-treated group and 99 to the BAK fusion—treated (control) group. Neurological status was equivalent between the two groups at 6, 12, and 24 months postoperatively. The number of patients with major, minor, or other neurological complications was equivalent. There was a greater incidence of both major and minor complications in the BAK fusion group at 0 to 42 days postoperatively. Compared with data reported in the lumbar fusion literature, the Charité disc—treated patients had equivalent or better mean changes in visual analog scale and Oswestry Disability Index scores.</jats:p> <jats:p content-type="fine-print"><jats:italic>Conclusions.</jats:italic> The Charité artificial disc is safe and effective for the treatment of single-level lumbar DDD, resulting in no higher incidence of neurological complications compared with BAK-assisted fusion and leading to equivalent or better outcomes compared with those obtained in the control group and those reported in the lumbar fusion literature.</jats:p>

Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up

“…The total improvement of pain in the FDA trials [4,10,27] was larger than in this study and the difference could be the effect of a different case mix in our series.…”

“…Subsequently, three ''IDE'' trials were designed and undertaken comparing different TDR techniques to fusion in order to reach FDA approval in the USA [4,10,27]. Extraction of pedicular screws 0 20 20…”

“…These studies were on highly selected cases and without equal randomisation to compare the effect of TDR with fusion. Many studies dealing with TDR [4,10,15,23,26,27] include patients with only one symptomatic level causing pain and dysfunction due to DDD, being discographypositive and without spondylosis or facet joint arthritis, the patients sampled thus representing a subgroup of all patients with painful motion segments. Based on these studies, TDR cannot be recommended for a wide group of patients with degenerative problems.…”

“…Follow-up at 1 and 2 years included a question on patient satisfaction with their treatment and a global outcome score of pain: total relief, much better, better, unchanged, or worse [8], which also constituted the primary outcome variable at 2 years. ODI success was described as [25% improvement, as in some FDA studies on TDR [4,10,27]. Complications and reoperations, including patients scheduled for reoperation, were recorded as they occurred.…”

Letter to the Editor concerning “Charité total disc replacement: clinical and radiographical results after an average follow-up of 17 years” (M. Putzier et al.)

“…The majority of opponents of TDR make the erroneous assumption that a lumbar fusion procedure is a winning procedure for the patient each and every time, despite ample evidence to the contrary, most recently described by Geisler et al [9]. Bringing forth the results in the earliest patients, as Putzier et al have done, with the procedures performed prior to all of the changes described above combined with the collective knowledge gained over two decades; and pronouncing that the long-term results are not at least as good as fusion, demonstrates a misunderstanding of how to interpret clinical literature.…”