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

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ClinicalTrials.gov Identifier: NCT01011816
Recruitment Status : 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))
First Posted : November 11, 2009
Results First Posted : May 5, 2014
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Spinal Restoration, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Back Pain
Chronic Low Back Pain
Internal Disc Disruption
Degenerative Disc Disease
Interventions Biological: BIOSTAT BIOLOGX
Drug: Saline
Enrollment 220

Recruitment Details  
Pre-assignment Details  
Arm/Group Title BIOSTAT BIOLOGX Saline
Hide Arm/Group Description One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
Period Title: 26-Week Primary Endpoint
Started 164 56
Completed 157 54
Not Completed 7 2
Period Title: 78-Week Extended Follow-up
Started 157 54
Completed 85 26
Not Completed 72 28
Arm/Group Title BIOSTAT BIOLOGX Saline Total
Hide Arm/Group Description One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device Total of all reporting groups
Overall Number of Baseline Participants 164 56 220
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 56 participants 220 participants
39.7  (10.7) 41.9  (11.4) 40.2  (10.9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 participants
Female
83
  50.6%
32
  57.1%
115
  52.3%
Male
81
  49.4%
24
  42.9%
105
  47.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 participants
Hispanic or Latino
8
   4.9%
5
   8.9%
13
   5.9%
Not Hispanic or Latino
156
  95.1%
51
  91.1%
207
  94.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.8%
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
   9.1%
2
   3.6%
17
   7.7%
White
147
  89.6%
52
  92.9%
199
  90.5%
More than one race
2
   1.2%
1
   1.8%
3
   1.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 164 participants 56 participants 220 participants
28.0  (6.1) 27.5  (5.6) 27.9  (5.9)
Currently Employed  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 participants
Yes 96 34 130
No 65 22 87
No Response 3 0 3
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 participants
Never 90 21 111
Previous 46 19 65
Current 28 16 44
Previous Back Surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 participants
None 161 55 216
Cervical 3 1 4
History Low Back Pain  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 participants
Yes 109 37 146
No 55 19 74
Lumbar Level Treated  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 participants
L3/L4 12 8 20
L4/L5 48 11 59
L5/S1 104 37 141
Reason for Stopping Injection  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 164 participants 56 participants 220 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] 
Mean (Standard Deviation)
Unit of measure:  Psi
Number Analyzed 164 participants 56 participants 220 participants
83.0  (29.3) 49.7  (25.7) 74.6  (31.9)
[1]
Measure Description: n=163 BIOSTAT BIOLOGX n=55 Saline
Injection Volume  
Mean (Standard Deviation)
Unit of measure:  Ml
Number Analyzed 164 participants 56 participants 220 participants
2.8  (0.9) 3.3  (0.8) 2.9  (0.9)
1.Primary Outcome
Title Subject Composite Success
Hide Description Subject success based on a composite of minimum 30% decrease in low back pain, 30% improvement in function, maintenance of neurological status, no secondary interventions, and no serious adverse events.
Time Frame 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects adjudicated as a success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).
Arm/Group Title BIOSTAT BIOLOGX Saline
Hide Arm/Group Description:

One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc

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

One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc

Saline: One injection of up to 4 mL of saline using the Biostat Delivery Device

Overall Number of Participants Analyzed 164 56
Measure Type: Number
Unit of Measure: percentage of subjects
33.5 39.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BIOSTAT BIOLOGX, Saline
Comments Null: No differenc between the percent success of Saline and BIOSTAT BIOLOGX
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Visual Analog Scale for Low Back Pain
Hide Description

Percent of subjects achieving a minimum 30% decrease in pain from baseline.

The visual analog scale is a horizontal 100 mm line anchored on the left with the words “No Pain” and on the right with the words “Worst Possible Pain”. Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the subject to indicate the subject’s level of low back pain experienced over the last week.

Time Frame 26-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects assigned success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).
Arm/Group Title BIOSTAT BIOLOGX Saline
Hide Arm/Group Description:
One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
Overall Number of Participants Analyzed 164 56
Measure Type: Number
Unit of Measure: percentage of subjects
42.1 50.0
3.Secondary Outcome
Title Roland-Morris Disability Questionnaire Score
Hide Description

Percent of subjects achieving a minimum 30% decrease in Roland-Morris Disability Questionnaire score

The Roland-Morris Disability Questionnaire is a widely studied and frequently used instrument for the assessment of function and disability related to low back pain. The questionnaire consists of 24 statements related to how a subject’s back condition affects various activities of daily living. Subjects marked whether the statement either applied to them or did not apply at the time they responded to the statements. The score is the total number of questions with which the subject agreed. A higher score indicates less function and greater disability.

Time Frame 26-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects assigned as success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).
Arm/Group Title BIOSTAT BIOLOGX Saline
Hide Arm/Group Description:
One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
Overall Number of Participants Analyzed 164 56
Measure Type: Number
Unit of Measure: percentage of subjects
52.4 50.0
Time Frame 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BIOSTAT BIOLOGX Saline
Hide Arm/Group Description One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
All-Cause Mortality
BIOSTAT BIOLOGX Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BIOSTAT BIOLOGX Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/164 (13.41%)      7/56 (12.50%)    
Cardiac disorders     
Myocardial Infarction  1  1/164 (0.61%)  1 1/56 (1.79%)  1
Endocrine disorders     
Adrenal Mass  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Gastrointestinal disorders     
Crohn's Disease  1  0/164 (0.00%)  0 1/56 (1.79%)  1
Diverticular Perforation  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Infections and infestations     
Pneumonia  1  2/164 (1.22%)  2 0/56 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  0/164 (0.00%)  0 1/56 (1.79%)  1
Wrist Fracture  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain  1  6/164 (3.66%)  7 1/56 (1.79%)  1
Intervertebral Disc Protrusion  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Osteoarthritis  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine Leiomyoma  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Nervous system disorders     
Cerebral Haemorrhage  1  0/164 (0.00%)  0 1/56 (1.79%)  1
Migraine  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Radiculopathy  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Psychiatric disorders     
Completed Suicide  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Conversion Disorder  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Delirium  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Eating Disorder  1  0/164 (0.00%)  0 1/56 (1.79%)  1
Substance Abuse  1  0/164 (0.00%)  0 1/56 (1.79%)  1
Renal and urinary disorders     
Nephrolithiasis  1  1/164 (0.61%)  1 2/56 (3.57%)  2
Reproductive system and breast disorders     
Uterine Haemorrhage  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Surgical and medical procedures     
Hysterectomy  1  1/164 (0.61%)  1 0/56 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
BIOSTAT BIOLOGX Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/164 (29.88%)      11/56 (19.64%)    
Injury, poisoning and procedural complications     
Fall  1  13/164 (7.93%)  14 3/56 (5.36%)  3
Musculoskeletal and connective tissue disorders     
Back Pain  1  20/164 (12.20%)  21 3/56 (5.36%)  3
Pain in Extremity  1  16/164 (9.76%)  16 3/56 (5.36%)  4
Arthralgia  1  6/164 (3.66%)  7 2/56 (3.57%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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.

Disclosure restrictions:

  • Sponsor can review results communication prior to public release and can embargo communications regarding trial results for up to 30 days from the time submitted for review.
  • If the communication contains patentable invention information, disclosure may be delayed up to 6 months for patent application filing.
  • If the communication contains confidential information, Sponsor will notify the PI to remove the confidential information prior to release.
Results Point of Contact
Name/Title: Jeff Doerzbacher
Organization: formerly Spinal Restoration, Inc
Publications:
Yin W, Pauza K, Olan W, Doerzbacher JF. Intradiscal injection of fibrin sealant for the treatment of symptomatic internal disc disruption: results of a prospective multicenter IDE pilot study with 6-month follow-up [ISIS Abstract]. Pain Medicine 10(5):955, 2009.
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
First Submitted: November 9, 2009
First Posted: November 11, 2009
Results First Submitted: April 2, 2014
Results First Posted: May 5, 2014
Last Update Posted: May 16, 2014