58. Viable disc tissue allograft supplementation in the treatment of degenerated intervertebral discs the one-year results of a randomized control trial

BACKGROUND CONTEXT A viable disc tissue allograft has been developed to supplement tissue loss associated with degenerative lumbar disc disease and the development of chronic discogenic lower back pain. The goal of an allogeneic disc matrix is to stabilize or restore the disc structure and normalize biomechanical functions and physiological loading to the disc. PURPOSE This unique viable disc allograft was injected into painful degenerated discs to evaluate safety and determine whether it can improve pain and function in patients with chronic discogenic low back pain. STUDY DESIGN/SETTING Randomized, controlled, multicenter study in US. PATIENT SAMPLE A total of 218 patients with chronic low back pain secondary to single-level or two-level degenerative disc disease were enrolled in the study. Patients had back pain for a minimum of 6 months that was recalcitrant to nonoperative treatment modalities. Inclusion criteria also included pretreatment VASPI ≥ 40 and ODI Score ≥ 40. OUTCOME MEASURES Clinical outcome instruments included Oswestry Disability Index (ODI) and visual analog scale of pain intensity (VASPI), neurological exam and adverse events. Plain film radiographs and magnetic resonance (MR) imaging scans were used to assess disc space height and spinal alignment, and to determine the degree of disc degeneration. METHODS Subjects were randomized and blinded to receive intradiscal injections of either viable disc allograft or saline or to continue nonblinded with nonsurgical management (NSM). The NSM group could cross over to the allograft group after 3 months. Patients were assessed at 6 and 12 months. Patient adverse events were continuously assessed. RESULTS At 12 months the VASPI and scores improved 30.5, 34.0, and 46.7 in the saline (S), active allograft (AA), and the crossover to allograft (COA) groups respectively, and the ODI scores improved 23.9, 27.4 and 36.4 in the same groups. This represents a 54% improvement in VASPI and a 53% improvement in ODI in the active allograft group. NSM subjects following crossover attained a 65% improvement in pain at 12 months combined with a 64% improvement in ODI. Responder rates were clinically significant for both ODI and VASPI with 76.5% of patients treated with AA showing improvement in ODI ≥ 15 points at 12 months vs 56.7% of patient treated in the S group (p=0.030) and 91.3% of the COA group vs 56.7% of the S group showing a ≥ 20-point improvement in VASPI (p=.006). In the allograft group, 11 safety adverse events occurred in 141 subjects (3.5%). The safety profile of the supplemental allograft was demonstrated to carry a risk similar to discography. CONCLUSIONS This large, prospective RCT showed safety and efficacy results demonstrating that viable disc tissue allograft is a safe treatment that produces significantly improved function and improved pain at 12 months. This technique may be a beneficial nonsurgical treatment for patients that have chronically painful lumbar degenerative discs. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.