Long-term observational studies are generally aligned with findings from the recent meta-analyses and 5-year randomized controlled trials (RCTs). As indicated previously, there are numerous studies that evaluate lumbar TDR for 5 or more years in duration. Several of these are observational studies, including commercially available lumbar TDR implants, which have reported a low risk of long-term complications with lumbar TDR (e.g., device migration, subsidence, reoperations).9–12 Siepe et al 13 conducted a long-term study of the ProDisc-L implant, with a mean follow-up of 7.4 years, and concluded that “fears of excessive late complications or reoperations with TDR cannot be substantiated with the present data.” In a 6-year single-center post-hoc analysis of IDE data including both the activL and ProDisc-L devices, implant subsidence was reported to be low for both devices (activL: 1.4%, ProDisc-L: 1.9%).14
There are now six RCTs, five of which are IDE trials, of lumbar TDR for the treatment of DDD with long-term 5-year follow-up data. Although definitions of adverse events varied across studies, the body of evidence demonstrates a good safety profile for lumbar TDR devices over this follow-up duration. Overall, very low device migration or subsidence rates were observed. In fact, in one RCT, lumbar fusion was reported to have a significantly greater number of severe or life-threatening adverse events compared with TDR (i.e., 0.58 vs. 0.38 per patient respectively; P = 0.0364).15 In this same study, lumbar fusion patients were three times more likely to have ASD than TDR (see Figure 1). Across trials, low rates of reoperations, and extremely low levels of particulate wear debris complications, were observed over 5 years.
Although the focus of the panel discussions was on the evidence that supports the long-term safety of lumbar TDR, additional complication considerations arose as part of discussion and questions within the survey. In brief, the evidence demonstrates that success with lumbar TDR is improved with appropriate patient selection.16,17 For example, Park et al 16 reported that there is a higher risk of revision surgeries in those not adherent to strict selection criteria for lumbar TDR. Many panel members confirmed the importance of adhering to selection criteria to minimize patient complications. A common theme generated through discussions and survey results was the use of experienced access surgeons, as well as tailored small incisions to help address complication risk. Common procedural challenges, when they do occur, included gaining full access to the disc space, ensuring an adequate release, and precisely positioning and sizing the implant. Use of experienced and trained surgeons for access was considered important to address these challenges. Additional techniques suggested to help minimize risk included having good intraoperative imaging, and maintaining appropriate imaging follow-up with specific measurements for potential migration. A detailed guideline of optimal techniques is not within the current scope of this article; however, as one surgeon noted, “good access, good visualization, a good release, and good judgment” are the bases for successful TDR procedures in the subpopulation of DDD sufferers who are candidates for TDR.
In summary, in reviewing the body of short and long-term evidence on lumbar TDR technology and considering the panel members’ practical experience, consensus opinion of experienced spinal surgeons was that lumbar TDR is well tested with a sufficient evidence base to support the safety of this technology for patients meeting well-established selection criteria.
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