Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
Public ClinicalTrials.gov record NCT01011816. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Blinded, Saline-Controlled Trial of Resorbable Biologic Disc Augmentation for Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another group receiving a preservative-free normal saline control delivered with the Biostat Delivery Device.
Study identification
- NCT ID
- NCT01011816
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 220 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2010 (Type not available)
- Primary completion
- Dec 2012 (Actual)
- Completion
- May 2013 (Actual)
- Last update posted
- May 16, 2014
2010 – 2013
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | — |
| HOPE Research Institute | Phoenix | Arizona | 85050 | — |
| Pain Control Associates of San Diego | Chula Vista | California | 91914 | — |
| Napa Pain Institute | Napa | California | 94559 | — |
| California Spine Diagnostics | San Francisco | California | 94115 | — |
| The Spine Institute | Santa Monica | California | 90403 | — |
| The Pain Institute, Inc | Merritt Island | Florida | 32953 | — |
| Millennium Pain Center | Bloomington | Illinois | 61701 | — |
| The Spine Center | Baltimore | Maryland | 21211 | — |
| Medical Advanced Pain Specialists Applied Research Center | Edina | Minnesota | 55435 | — |
| NewSouth NeuroSpine Pain Center | Flowood | Mississippi | 39232 | — |
| OrthoCarolina Spine Center | Charlotte | North Carolina | 28207 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| OrthoNeuro, Inc. | New Albany | Ohio | 43054 | — |
| Allegheny Pain Management | Altoona | Pennsylvania | 16602 | — |
| Orthopaedic & Spine Specialists | York | Pennsylvania | 17402 | — |
| Spine Specialists PA | Tyler | Texas | 75701 | — |
| Virginia Spine Research Institute | Richmond | Virginia | 23235 | — |
| Advanced Pain Management | Virginia Beach | Virginia | 23454 | — |
| Bellingham Spine Pain Specialists PS | Bellingham | Washington | 98226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01011816, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 16, 2014 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01011816 live on ClinicalTrials.gov.