P53. Allogeneic disc matrix as treatment for disc degeneration: improvement in pain and function at 1- and 2-levels

Abstract

BACKGROUND CONTEXT Chronic back pain has been linked to genetic, metabolic, and mechanical imbalance, and although physical therapy, dieting, core strengthening, and anti-inflammatory medication have offered symptomatic relief, to date there has been no remedy for tissue regeneration of the disc or replenishing tissue loss to degeneration. PURPOSE This study evaluated whether placement of a supplemental structural cellular allograft matrix at either 1 or 2 levels could effectively augment tissue lost to degeneration. Safety, and efficacy over a minimum of 6 months are presented. STUDY DESIGN/SETTING Following IRB approval, a prospective, randomized 3-arm study was designed. Safety and efficacy of structural disc allograft matrix was evaluated up to 6 months. (ClinicalTrials.gov NCT03709901). PATIENT SAMPLE This study compares 204 enrolled patients 6 months following the index procedure. Subjects consisted of 43% females and 57% males. OUTCOME MEASURES Visual analog scale (VAS), and Oswestry Disability Index (ODI) were the primary symptomatic assessments. METHODS Following IRB approval, a prospective, randomized 3-arm study was designed. Safety and efficacy of structural disc allograft matrix was evaluated up to 6 months. (ClinicalTrials.gov NCT03709901).; demographics of age 42.7 (19-73), and BMI 27.6 (17-35.4) were similar between the groups. Subjects were randomized to receive allogeneic disc tissue matrix consisting of disc material with a cellular component, saline placebo, or continue in conservative care. Patients received intradiscal injections at 1 or 2 levels. Subject distribution included 134 active allograft, 38 receiving saline placebo, and 32 continuing conservative care. There were 119 subjects with 1-level intervention, and 85 received 2-level. Visual Analog Scale (VAS), and Oswestry Disability Index (ODI) were the primary symptomatic assessments at 6 months. RESULTS Back pain, as measured by VAS was reduced in all subjects treated by active agents. All conservative management subjects crossed over at 3 months due to persistent pain. Allograft pain scores decreased from 64.33 to 33.27 (31.06; 48.3% reduction); saline placebo decreased from 66.06 to 43.87 (22.19; 33.6% reduction); and conservative care after cross over to structural allograft decreased from 68.67 to 21.27 (47.40; reduction 69%). A greater than 20-point improvement in ODI mean scores was reported in both active allograft and cross-over groups at 6 months. The crossover group with 2 levels treated reported most significant improvements in pain and function across all three groups. Pain scores decreased from 63.6 to 12.8 and ODI decreased from 51.7 to 19. CONCLUSIONS Intradiscal allograft demonstrated symptomatic relief and provided the largest improvement in ODI at either 1- or 2-levels treated, whether randomized and blinded, or after crossover with open label compared to placebo (saline). Subjects in the conservative treatment arm after three additional months of conservative care achieved comparable symptomatic relief to the initial treatment arm, despite the time lapse of 3 months. Functional improvements and pain reduction were linked to the number of levels treated, suggesting that disc height improvement might bridge more than single levels. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.