Abstract
Background: Disruption of the internal structure of the nucleus pulposus commonly occurs with the development of painful degenerative lumbar disc disease. Supplementing disc tissue through autologous or allogeneic human cellular and tissue therapies has been tested in small sample clinical trials. A few investigators have reported substantial improvements in pain and function. A viable disc tissue allograft was developed to supplement tissue loss associated with intervertebral disc degeneration. Methods: We assessed results in a subgroup of patients from a large trial comparing this allograft with other treatments. A multicenter randomized controlled trial of 218 subjects with chronic low back pain secondary to degenerative disc disease was conducted. Patients were treated with the allograft, saline, or nonsurgical management and studied for 12 months. We assessed longer-term results in a single-site subgroup from this prospective trial.Results: At 12 months, subjects from the single-site subgroup who had been randomly assigned to the active allograft group (n=17) showed improvements in both mean Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) scores. There was an overall reduction of 28.69 points in the ODI and 33.06 points in the VAS. This was similar to the aggregate ODI and VAS scores of the active allograft group. At 24 months postprocedure, 9 of the 10 patients remaining in the active allograft group at the single study site had mean ODI and VAS score improvements of 28.23 and 36.13, respectively. A similar improvement in pain scores occurred in the 4 patients at 36 months with mean ODI and VAS score improvements from preoperative scores of 25.21 and 51.35, respectively.Conclusions: Clinically meaningful improvements demonstrated in this single-site analysis were comparable to the aggregate study population at 12 months. Longer-term results from this single site at 24 and 36 months suggested durability of viable disc tissue allograft supplementation for patients with discogenic back pain.Trial registration: The trial was retrospectively registered 17 October 2018 on www.clinicaltrials.gov (NCT03709901) and was approved by the Sterling Institutional Review Board, Atlanta, Georgia (IRB no. 5792).
Treatment of Degenerated Intervertebral Discs Using a Viable Disc Tissue Allograft for Chronic Discogenic Low Back Pain: A Randomized Controlled Trial Comparing Single-site Outcomes With Aggregate and Longer-Term Follow-Up Data
