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

Authors


  • 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.

Abstract

Objective

Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain.

Design

Prospective, nonrandomized Food and Drug Administration approved pilot study.

Setting

Three centers in the United States.

Subjects

Fifteen adults with chronic, single, or contiguous two-level lumbar discogenic pain confirmed through meticulous provocation discography.

Interventions

Volume- and pressure-controlled intradiscal delivery of BIOSTAT BIOLOGX® Fibrin Sealant with the Biostat® Delivery Device into symptomatic lumbar disc(s).

Outcome Measures

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).

Results

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.

Efficacy

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.

Conclusion

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.

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