Safety Evaluation of Intradiscal Delivery of Nucleus Pulposus Allograft for Lumbar Discogenic Pain.

BackgroundPersistent concerns remain about the deleterious pathological effects of minimally invasive transannular puncture, such as occurs during discography and therapeutic intradiscal procedures. The objective of this study was to estimate the safety profile associated with fluoroscopically guided intradiscal delivery of nucleus pulposus (NP) allograft under clinical trial and real-world conditions.MethodsThis was a retrospective pooled analysis of adverse events (AEs) and clinical complaints captured from 4 different treatment populations (n = 392) and a database of commercial cases (n = 19,392 discs treated) with lumbar discogenic pain who underwent minimally invasive intradiscal NP allograft supplementation. All AEs were graded for severity as mild, moderate, or severe, and relatedness was judged as possibly, probably, or definitely. All serious AEs were adjudicated for outcome.ResultsThere were 51 total AEs reported across all 4 clinical cohorts, and 6 AEs (12%) were judged to be related to the NP allograft product and the intradiscal procedure, with an additional 4 AEs (8%) related solely to the intradiscal procedure. None of the AEs was associated with infection (ie, discitis), neurological compromise, or escalation to surgical treatment. The product-attributable serious AE incidence was 0.26% (1/392). Of the commercial cases (n = 19,392 discs treated), no clinical AEs were reported from this cohort, with only 101 device complaints (0.521%) related primarily to delivery interface or packaging integrity.ConclusionsIntradiscal NP allograft supplementation for symptomatic degenerative disc disease demonstrates a favorable safety profile. These findings serve to temper concerns about the risk of disc complications and accelerated degeneration following transannular puncture.Clinical relevanceThese findings validate that the NP allograft product and procedure have an exemplary safety profile. As a microinvasive, motion-preserving intervention, this procedure has the potential to bridge the therapeutic gap between conservative care and invasive spine surgery for patients suffering from discogenic back pain.Level of evidence: 4