Lumbar artificial disc yielded positive 7-year outcomes for degenerative disc disease
For total disc replacement in patients with degenerative disc disease, an artificial disc is a safe option that improves pain relief, function, range of motion and decreases in opioid use, according to published results.
In an FDA investigational device exemption, prospective study, Kris Radcliff, MD, and colleagues compared 7-year safety and efficacy outcomes of two generations of total disc replacement systems: the activL artificial disc (Aesculap Implant Systems) and the ProDisc-L (Aesculap Implant Systems).
According to the study, researchers randomized 283 patients with symptomatic, single-level lumbar degenerative disc disease who had failed 6 months of nonsurgical management to receive either the activL (n = 218) or the ProDisc-L (n = 65). Outcome measures included safety profile, pain reduction, function, range of motion (ROM) and opioid use.
As both cohorts saw improved outcomes, Radcliff and colleagues determined the activL to be noninferior to the ProDisc-L in pain reduction, function and opioid use. However, they noted that the activL resulted in improved ROM and was potentially the safer option.
“activL was more effective at preserving motion and had a more favorable safety profile than ProDisc-L, although other efficacy outcomes were similar between discs,” the researchers wrote in the study. “A very important finding from this study was that opioid use in this chronic low back pain population was reduced to 0% after 7 years from a preoperative rate of 65%,” they added.