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Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00693784
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : April 29, 2010
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
Spinal Restoration, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Low Back Pain
Intervention Biological: Biostat® Disc Augmentation System
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BIOSTAT BIOLOGX
Hide Arm/Group Description 1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Period Title: Overall Study
Started 15
26-Week Primary Endpoint 15
52-week Extended Follow-up 13
104-week Extended Follow-up 11
Completed 11
Not Completed 4
Reason Not Completed
Lost to Follow-up             2
Withdrawal by Subject             2
Arm/Group Title BIOSTAT BIOLOGX
Hide Arm/Group Description 1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
1
   6.7%
Between 18 and 65 years
13
  86.7%
>=65 years
1
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
43.9  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
7
  46.7%
Male
8
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Numbers and Types of Adverse Events (Only Number of Events is Reported in This Section - See Adverse Events Section for Further Detail)
Hide Description The primary outcome for this safety study includes the number and types of adverse events reported in the study. The data fields in this section do not allow for reporting all aspects of this outcome (i.e., the number of adverse events, as well as the types of event). These numbers were entered and are reported in the adverse event section of the Results.
Time Frame 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 15 participants available through 26-week primary endpoint. One voluntary withdrawal and 1 lost-to-follow-up between 26-week follow-up and 52-week extended follow-up. One additional voluntary withdrawal and 1 additional lost-to-follow-up between 52-week extended follow-up and 104-week extended follow-up.
Arm/Group Title BIOSTAT BIOLOGX
Hide Arm/Group Description:
1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Events
17
2.Secondary Outcome
Title Visual Analog Scale for Low-back Pain
Hide Description 100 mm line anchored on the left with the descriptor "No pain" (best value = 0 mm) and anchored on the right with the descriptor "Worst possible pain" (worst value = 100 mm). Lower scores indicate less pain.
Time Frame Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks
Arm/Group Title BIOSTAT BIOLOGX
Hide Arm/Group Description:
1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: mm
Baseline 72.4  (14.2)
26-wks 31.7  (26.0)
52-wks 35.4  (29.3)
104-wks 33.0  (24.8)
3.Secondary Outcome
Title Roland-Morris Disability Questionnaire
Hide Description 24-item questionnaire with score determined by the number of items checked by the subject. Items assess the effect of back pain on limitations of normal daily activities. Best value = 0 (least disability). Worst value = 24 (most disability). Higher number indicate greater disability.
Time Frame Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks
Arm/Group Title BIOSTAT BIOLOGX
Hide Arm/Group Description:
1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 15.2  (4.5)
26-weeks 8.9  (6.5)
52-weeks 6.2  (4.7)
104-weeks 5.6  (4.1)
Time Frame 104 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BIOSTAT BIOLOGX
Hide Arm/Group Description 1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
All-Cause Mortality
BIOSTAT BIOLOGX
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
BIOSTAT BIOLOGX
Affected / at Risk (%) # Events
Total   2/15 (13.33%)    
Infections and infestations   
Discitis * 1  1/15 (6.67%)  1
Renal and urinary disorders   
Tumor * 1 [1]  1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, custom
[1]
Kidney tumor present but undetected at baseline.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BIOSTAT BIOLOGX
Affected / at Risk (%) # Events
Total   9/15 (60.00%)    
General disorders   
Trip/fall * 1  3/15 (20.00%)  3
Motor vehicle accident * 1  1/15 (6.67%)  2
Immune system disorders   
Herpes * 1  1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders   
Muscle spasm * 1  2/15 (13.33%)  2
Buttock Pain * 1  1/15 (6.67%)  1
Sacroiliitis * 1  1/15 (6.67%)  1
Low back pain * 1  4/15 (26.67%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, custom
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeff F. Doerzbacher
Organization: Spinal Restoration, Inc.
Phone: 512 225-0405
EMail: jeffdoerzbacher@spinalrestoration.com
Layout table for additonal information
Responsible Party: Spinal Restoration, Inc.
ClinicalTrials.gov Identifier: NCT00693784    
Other Study ID Numbers: SR-BX01P-2007
First Submitted: June 4, 2008
First Posted: June 9, 2008
Results First Submitted: March 8, 2010
Results First Posted: April 29, 2010
Last Update Posted: June 22, 2015