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

This study has been terminated.
(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))
Sponsor:
Information provided by (Responsible Party):
Spinal Restoration, Inc.
ClinicalTrials.gov Identifier:
NCT01011816
First received: November 9, 2009
Last updated: May 5, 2014
Last verified: May 2014
Results First Received: April 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Back Pain
Chronic Low Back Pain
Internal Disc Disruption
Degenerative Disc Disease
Interventions: Biological: BIOSTAT BIOLOGX
Drug: Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BIOSTAT BIOLOGX One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
Saline One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device

Participant Flow for 2 periods

Period 1:   26-Week Primary Endpoint
    BIOSTAT BIOLOGX     Saline  
STARTED     164     56  
COMPLETED     157     54  
NOT COMPLETED     7     2  

Period 2:   78-Week Extended Follow-up
    BIOSTAT BIOLOGX     Saline  
STARTED     157     54  
COMPLETED     85     26  
NOT COMPLETED     72     28  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BIOSTAT BIOLOGX One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
Saline One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
Total Total of all reporting groups

Baseline Measures
    BIOSTAT BIOLOGX     Saline     Total  
Number of Participants  
[units: participants]
  164     56     220  
Age  
[units: years]
Mean ± Standard Deviation
  39.7  ± 10.7     41.9  ± 11.4     40.2  ± 10.9  
Age, Customized  
[units: participants]
     
≥18-≤29 years     30     11     41  
≥30-≤39 years     50     12     62  
≥40-≤49 years     51     20     71  
≥50-≤59 years     28     9     37  
≥60 years     5     4     9  
Gender  
[units: participants]
     
Female     83     32     115  
Male     81     24     105  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     8     5     13  
Not Hispanic or Latino     156     51     207  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     15     2     17  
White     147     52     199  
More than one race     2     1     3  
Unknown or Not Reported     0     0     0  
BMI  
[units: kg/m^2]
Mean ± Standard Deviation
  28.0  ± 6.1     27.5  ± 5.6     27.9  ± 5.9  
Currently Employed  
[units: participants]
     
Yes     96     34     130  
No     65     22     87  
No Response     3     0     3  
Smoking Status  
[units: participants]
     
Never     90     21     111  
Previous     46     19     65  
Current     28     16     44  
Previous Back Surgery  
[units: participants]
     
None     161     55     216  
Cervical     3     1     4  
History Low Back Pain  
[units: participants]
     
0.5 - 1 year     7     3     10  
1 - <5 years     76     24     100  
5 - <10 years     41     9     50  
10 - <20 years     32     12     44  
>=20 years     8     8     16  
History Right Leg Pain  
[units: participants]
     
None     118     40     158  
<1 year     8     3     11  
1 - <2 years     11     2     13  
2 - <3 years     11     5     16  
3 - <4 years     2     0     2  
>=4 years     14     6     20  
History Left Leg Pain  
[units: participants]
     
None     110     33     143  
<1 year     11     6     17  
1 - <2 years     7     2     9  
2 - <3 years     14     7     21  
3 - <4 years     3     1     4  
>=4years     19     7     26  
Baseline Opioid Medication for Back Pain  
[units: participants]
     
Yes     109     37     146  
No     55     19     74  
Lumbar Level Treated  
[units: participants]
     
L3/L4     12     8     20  
L4/L5     48     11     59  
L5/S1     104     37     141  
Reason for Stopping Injection  
[units: participants]
     
Subject Discomfort     4     2     6  
Maximum Pressure Reached     91     6     97  
Total Available Volume Delivered     68     45     113  
Other [investigator discretion; saline backflow]     1     3     4  
Maximum Injection Pressure [1]
[units: psi]
Mean ± Standard Deviation
  83.0  ± 29.3     49.7  ± 25.7     74.6  ± 31.9  
Injection Volume  
[units: ml]
Mean ± Standard Deviation
  2.8  ± 0.9     3.3  ± 0.8     2.9  ± 0.9  
[1] n=163 BIOSTAT BIOLOGX n=55 Saline



  Outcome Measures
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1.  Primary:   Subject Composite Success   [ Time Frame: 26 weeks ]

2.  Secondary:   Visual Analog Scale for Low Back Pain   [ Time Frame: 26-weeks ]

3.  Secondary:   Roland-Morris Disability Questionnaire Score   [ Time Frame: 26-weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jeff Doerzbacher
Organization: formerly Spinal Restoration, Inc
e-mail: jdoerzbacher@renascentmed.com


Publications:

Responsible Party: Spinal Restoration, Inc.
ClinicalTrials.gov Identifier: NCT01011816     History of Changes
Other Study ID Numbers: SR-BX01-2007
Study First Received: November 9, 2009
Results First Received: April 2, 2014
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration