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Terminated Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01011816

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.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 1:19 PM EDT

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

Study identification

NCT ID
NCT01011816
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Spinal Restoration, Inc.
Industry
Enrollment
220 participants

Conditions and interventions

Interventions

  • BIOSTAT BIOLOGX Biological
  • Saline Drug

Biological · Drug

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
Feb 28, 2010
Primary completion
Nov 30, 2012
Completion
Apr 30, 2013
Last update posted
May 15, 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 15, 2014 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01011816 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →