We now have data from the early disc arthroplasty patients. In a 17 year follow-up study of 51 disc arthroplasty (non-fusion) patients, the data suggest that both the technology and the surgeons employing it have been walking up a steep learning curve.
European artificial disc experience
We looked back at two decades of European disc arthroplasty experience to understand what will happen in the US. The European experience is instructive. For example:
- The learning curve for surgeons is steep. It is very surgeon specific and requires significant attention to detail.
- When performed well, the average operative time is 90 minutes with minimal blood loss.
- Patient selection is critical. Best patients are young, active, motivated with chronic discogenic low back pain at either L4-L5 or L5-S1 levels.
US study results
The U.S. IDE study led by the Texas Back Institute for Johnson and Johnson reported that 88% of the patients expressed satisfaction with the SB Charite at 24 months. 82% said they would choose the Charite artificial disc again.
Not included in those U.S. study results were the complication rates in the first 71 cases. The vast preponderance of major complications occurred in these “training patients.” Most surgeons using the Charite artificial disc experience learning curve related problems in the first five discal arthroplasties. Until those are under their belt, outcomes are worse than fusion.