Phase III Clinical Trial Spinal Restoration is currently enrolling patients in a Phase III clinical trial of the Biostat System for the treatment of discogenic chronic low back pain. To learn more about the study or find out if you qualify to participate, please visit www.lowbackstudy.com. Additional information about the study can be found on www.clinicaltrials.gov (Identifier: NCT01011816).
Pilot Clinical Study
A multicentered FDA pilot investigation was conducted to provide a preliminary assessment of the safety and efficacy of the Biostat System for treatment discogenic chronic low back pain.1,2 Fifteen patients with single (12) or two-level (3) discogenic pain where enrolled at 3 U.S. centers. Subjects were assessed after treatment at 72 hours and 1, 4, 13, and 26 weeks (6 months). Long-term follow-up visits were conducted after 52 weeks (1 year) and 104 weeks (2 years). Adverse event reports, neurological exams, and imaging studies were used to assess safety. Efficacy measures included the Visual Analog Scale (VAS) for low back pain and the Roland-Morris Disability Questionnaire (RMDQ), among others.
All 15 subjects were evaluated at the 6 month primary study endpoint. Thirteen (87%) and 11 (73%) of the patients completed the 1 and 2 year follow-up visits, respectively. There were no unanticipated adverse events. Three adverse events were considered potentially related to the procedure. These consisted of two cases of back spasms in the early post-treatment period (<4 weeks) and one case of disc infection. There were no adverse changes in the neurological exams and imaging evaluations through the 2 year follow-up visit.
Mean low back pain scores (VAS) decreased from 72.4 mm (95% CI: 64.6-80.3) at baseline to 31.7 mm (17.4-46.1), 35.4 mm (17.7-53.1) and 33.0 mm (16.3-49.6) at 6 months, 1 year, and 2 years, respectively. The mean individual reductions in low back VAS scores were 45.2% (14.0-76.3), 55.6% (36.5-74.6), 51.2% (27.9-74.5) and 49.9% (22.8-77.0). At least 30% reduction in low back pain VAS score was reported by 13 of 15 subjects (87%) at the 6 month primary endpoint. At the 1 and 2 year visits, 61.5% (8 of 13) and 72.7% (8 of 11) of the subjects evaluated reported at least a 30% reduction in low back pain VAS.
Mean RMDQ scores 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 6 months, I year, and 2 years, respectively. The mean individual improvements in RMDQ scores were 41.9% (21.6-62.2), 58.7% (40.5-76.8) and 60.6% (37.7-83.5). At least 30% improvement in RMDQ score was reported by 11 of 15 subjects (73.3%) at the 6 month primary endpoint. At the 1 and 2 year visits, 84.6% (11 of 13) and 81.2% (9 of 11) of the subjects evaluated reported at least a 30% improvement in RMDQ score.
The pilot study results indicate further study is warranted to determine if the Biostat System is safe and effective treatment option for patients suffering from discogenic chronic low back pain. Additional data from this pilot study are available at ClinicalTrials.gov (NCT00693784).
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| Mean low back pain Visual Analog Scale (VAS) Score | Mean Roland-Morris Disability Questionnaire (RMDQ) Score |
1 Yin W, Pauza K, Olan W, Doerzbacher JF. Intradiscal injection of fibrin sealant for the treatment of symptomatic internal disc disruption: results of a prospective multicenter IDE pilot study with 6-month follow-up. International Spine Intervention Society Annual Meeting Abstracts. Pain Medicine 2009; 10:955.
2 Yin W, Pauza K, Olan W, Doerzbacher JF. Long-Term Outcomes from a Prospective, Multicenter Investigational Device Exemption (IDE) Pilot Study of Intradiscal Fibrin Sealant for the Treatment of Discogenic Pain. International Spine Intervention Society -2011 19th Annual Scientific Meeting Research Abstracts. Pain Medicine 2011; 12(9):1446-1447.