Disclosures: This study was sponsored by Spinal Restoration, Inc. Drs. Yin, Pauza, and Olan are members of the Clinical Advisory Board and have been granted options, own stock or receive consulting fees from Spinal Restoration. Jeff Doerzbacher is Director of Regulatory and Clinical Affairs, and Dr. Thorne is Director of Scientific Affairs for the sponsor.
Original Research Article
Intradiscal Injection of Fibrin Sealant for the Treatment of Symptomatic Lumbar Internal Disc Disruption: Results of a Prospective Multicenter Pilot Study with 24-Month Follow-Up
Article first published online: 23 OCT 2013
Wiley Periodicals, Inc
Volume 15, Issue 1, pages 16–31, January 2014
How to Cite
Yin, W., Pauza, K., Olan, W. J., Doerzbacher, J. F. and Thorne, K. J. (2014), Intradiscal Injection of Fibrin Sealant for the Treatment of Symptomatic Lumbar Internal Disc Disruption: Results of a Prospective Multicenter Pilot Study with 24-Month Follow-Up. Pain Medicine, 15: 16–31. doi: 10.1111/pme.12249
- Issue published online: 16 JAN 2014
- Article first published online: 23 OCT 2013
- Spinal Restoration, Inc.
- Low Back Pain;
- Discogenic Pain;
- Intervertebral Disc;
- Fibrin Sealant
Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain.
Prospective, nonrandomized Food and Drug Administration approved pilot study.
Three centers in the United States.
Fifteen adults with chronic, single, or contiguous two-level lumbar discogenic pain confirmed through meticulous provocation discography.
Volume- and pressure-controlled intradiscal delivery of BIOSTAT BIOLOGX® Fibrin Sealant with the Biostat® Delivery Device into symptomatic lumbar disc(s).
Assessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland-Morris Disability Questionnaire (RMDQ).
Safety neurological assessments, X-ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product.
Mean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6–80.3) at baseline to 31.7 (17.4–46.1), 35.4 (17.7–53.1), and 33.0 (16.3–49.6); mean RMDQ score improved from 15.2 (12.7–17.7) at baseline to 8.9 (5.3–12.5), 6.2 (3.4–9.1), and 5.6 (2.9-8.4) at 26, 52, and 104 weeks, respectively.
Intradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain.