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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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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 
Overall Participants Analyzed 
[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) 
[1] n=163 BIOSTAT BIOLOGX n=55 Saline
Injection Volume 
[Units: Ml]
Mean (Standard Deviation)
 2.8  (0.9)   3.3  (0.8)   2.9  (0.9) 


  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:
Buser Z, Keulling F, Jane L, Liebenberg E, Tang J, Thorne K, Coughlin D, Lotz J. Fibrin injection stimulates early disc healing in the porcine model [NASS Abstract 199]. Spine Journal 9:105S, 2009.
Pauza K, Yin W, Olan W, Doerzbacher JF. BIOSTAT BIOLOGX(R) intradiscal fibrin sealant used for treatment of chronic low back pain caused by lumbar disc disruption: results of a 12 month, prospective multicenter pilot study. Spine Arthroplasty Society Meeting, April 27-30, 2010; New Orleans, LA. Abstract 248.
Yin W, Pauza K, Olan W, Doerzbacher JF. Long-term outcomes from a prospective, multicenter investigational device exemption (IDE) pilot study of intradiscal fibrin sealant for the treatment of discogenic pain [ISIS Abstract]. Pain Medicine 12:1446-1447, 2011


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