Trial Outcomes & Findings for Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study (NCT NCT00693784)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

104 weeks

Results posted on

2015-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	BIOSTAT BIOLOGX 1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Overall Study STARTED	15
Overall Study 26-Week Primary Endpoint	15
Overall Study 52-week Extended Follow-up	13
Overall Study 104-week Extended Follow-up	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	BIOSTAT BIOLOGX 1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BIOSTAT BIOLOGX n=15 Participants 1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	43.9 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 104 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	BIOSTAT BIOLOGX n=15 Participants 1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Numbers and Types of Adverse Events (Only Number of Events is Reported in This Section - See Adverse Events Section for Further Detail)	17 Events

SECONDARY outcome

Timeframe: Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks

Population: n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks

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.

Outcome measures

Outcome measures
Measure	BIOSTAT BIOLOGX n=15 Participants 1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Visual Analog Scale for Low-back Pain Baseline	72.4 mm Standard Deviation 14.2
Visual Analog Scale for Low-back Pain 26-wks	31.7 mm Standard Deviation 26.0
Visual Analog Scale for Low-back Pain 52-wks	35.4 mm Standard Deviation 29.3
Visual Analog Scale for Low-back Pain 104-wks	33.0 mm Standard Deviation 24.8

SECONDARY outcome

Timeframe: Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks

Population: n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks

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.

Outcome measures

Outcome measures
Measure	BIOSTAT BIOLOGX n=15 Participants 1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Roland-Morris Disability Questionnaire Baseline	15.2 Units on a scale Standard Deviation 4.5
Roland-Morris Disability Questionnaire 26-weeks	8.9 Units on a scale Standard Deviation 6.5
Roland-Morris Disability Questionnaire 52-weeks	6.2 Units on a scale Standard Deviation 4.7
Roland-Morris Disability Questionnaire 104-weeks	5.6 Units on a scale Standard Deviation 4.1

Adverse Events

BIOSTAT BIOLOGX

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BIOSTAT BIOLOGX n=15 participants at risk 1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Infections and infestations Discitis	6.7% 1/15 • Number of events 1 • 104 weeks
Renal and urinary disorders Tumor	6.7% 1/15 • Number of events 1 • 104 weeks

Other adverse events

Other adverse events
Measure	BIOSTAT BIOLOGX n=15 participants at risk 1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
Musculoskeletal and connective tissue disorders Muscle spasm	13.3% 2/15 • Number of events 2 • 104 weeks
Musculoskeletal and connective tissue disorders Buttock Pain	6.7% 1/15 • Number of events 1 • 104 weeks
Musculoskeletal and connective tissue disorders Sacroiliitis	6.7% 1/15 • Number of events 1 • 104 weeks
Immune system disorders Herpes	6.7% 1/15 • Number of events 1 • 104 weeks
General disorders Trip/fall	20.0% 3/15 • Number of events 3 • 104 weeks
General disorders Motor vehicle accident	6.7% 1/15 • Number of events 2 • 104 weeks
Musculoskeletal and connective tissue disorders Low back pain	26.7% 4/15 • Number of events 5 • 104 weeks

Additional Information

Jeff F. Doerzbacher

Spinal Restoration, Inc.

Phone: 512 225-0405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60