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
Data collected from a 15-patient FDA pilot investigation of the Biostat System is extremely encouraging and supportive of the safety and potential efficacy of Spinal Restoration’s new therapy. The study, conducted at 3 U.S. centers, demonstrated meaningful improvements for a majority of patients in both pain and function.
At the 6 month primary endpoint, 13 of 15 patients (86.6%) reported at least a 30% reduction in their Visual Analog Scale (VAS) score compared to baseline, and 10 of 15 (66.6%) achieved at least a 50% reduction in VAS. Patient function assessed using the Roland-Morris Disability Questionnaire (RMDQ) demonstrated similar improvements. 11 of 15 patients (73.3%) reported at least a 30% improvement in RMDQ score, while 8 of 15 patients (53.3%) reported at least a 50% improvement in RMDQ. Mean VAS improved 40.7 mm (55.6%) and mean RMDQ improved 6.3 points (41.9%). There were no unanticipated adverse events. One procedure-related complication occurred (disc infection).1 Additional follow up visits are planned at 1 and 2 years.
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| Pilot study results: mean low back pain Visual Analog Score (VAS) | Pilot study results: 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. Pain Medicine 2009; 10:955.