# Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System

> **NCT01011816** · PHASE3 · TERMINATED · sponsor: **Spinal Restoration, Inc.** · enrollment: 220 (actual)

## Conditions studied

- Back Pain
- Chronic Low Back Pain
- Internal Disc Disruption
- Degenerative Disc Disease

## Interventions

- **BIOLOGICAL:** BIOSTAT BIOLOGX
- **DRUG:** Saline

## Key facts

- **NCT ID:** NCT01011816
- **Lead sponsor:** Spinal Restoration, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2010-03
- **Primary completion:** 2012-12
- **Final completion:** 2013-05
- **Target enrollment:** 220 (ACTUAL)
- **Why stopped:** Stopped prior to last subject's last extended follow-up visit (78 weeks) due to lack of efficacy at the primary study endpoint (26 weeks)
- **Last updated:** 2014-05-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01011816

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01011816, "Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT01011816. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*