Trial Outcomes & Findings for Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System (NCT NCT01011816)
NCT ID: NCT01011816
Last Updated: 2014-05-16
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
220 participants
Primary outcome timeframe
26 weeks
Results posted on
2014-05-16
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
26-Week Primary Endpoint
STARTED
|
164
|
56
|
|
26-Week Primary Endpoint
COMPLETED
|
157
|
54
|
|
26-Week Primary Endpoint
NOT COMPLETED
|
7
|
2
|
|
78-Week Extended Follow-up
STARTED
|
157
|
54
|
|
78-Week Extended Follow-up
COMPLETED
|
85
|
26
|
|
78-Week Extended Follow-up
NOT COMPLETED
|
72
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
Baseline characteristics by cohort
| Measure |
BIOSTAT BIOLOGX
n=164 Participants
One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
|
Saline
n=56 Participants
One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Age, Customized
≥18-≤29 years
|
30 participants
n=5 Participants
|
11 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Age, Customized
≥30-≤39 years
|
50 participants
n=5 Participants
|
12 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Age, Customized
≥40-≤49 years
|
51 participants
n=5 Participants
|
20 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Age, Customized
≥50-≤59 years
|
28 participants
n=5 Participants
|
9 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Age, Customized
≥60 years
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
156 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
147 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
28.0 kg/m^2
STANDARD_DEVIATION 6.1 • n=5 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 5.6 • n=7 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Currently Employed
Yes
|
96 participants
n=5 Participants
|
34 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Currently Employed
No
|
65 participants
n=5 Participants
|
22 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Currently Employed
No Response
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Smoking Status
Never
|
90 participants
n=5 Participants
|
21 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Smoking Status
Previous
|
46 participants
n=5 Participants
|
19 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Smoking Status
Current
|
28 participants
n=5 Participants
|
16 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Previous Back Surgery
None
|
161 participants
n=5 Participants
|
55 participants
n=7 Participants
|
216 participants
n=5 Participants
|
|
Previous Back Surgery
Cervical
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
History Low Back Pain
0.5 - 1 year
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
History Low Back Pain
1 - <5 years
|
76 participants
n=5 Participants
|
24 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
History Low Back Pain
5 - <10 years
|
41 participants
n=5 Participants
|
9 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
History Low Back Pain
10 - <20 years
|
32 participants
n=5 Participants
|
12 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
History Low Back Pain
>=20 years
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
History Right Leg Pain
None
|
118 participants
n=5 Participants
|
40 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
History Right Leg Pain
<1 year
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
History Right Leg Pain
1 - <2 years
|
11 participants
n=5 Participants
|
2 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
History Right Leg Pain
2 - <3 years
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
History Right Leg Pain
3 - <4 years
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
History Right Leg Pain
>=4 years
|
14 participants
n=5 Participants
|
6 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
History Left Leg Pain
None
|
110 participants
n=5 Participants
|
33 participants
n=7 Participants
|
143 participants
n=5 Participants
|
|
History Left Leg Pain
<1 year
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
History Left Leg Pain
1 - <2 years
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
History Left Leg Pain
2 - <3 years
|
14 participants
n=5 Participants
|
7 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
History Left Leg Pain
3 - <4 years
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
History Left Leg Pain
>=4years
|
19 participants
n=5 Participants
|
7 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Baseline Opioid Medication for Back Pain
Yes
|
109 participants
n=5 Participants
|
37 participants
n=7 Participants
|
146 participants
n=5 Participants
|
|
Baseline Opioid Medication for Back Pain
No
|
55 participants
n=5 Participants
|
19 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Lumbar Level Treated
L3/L4
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Lumbar Level Treated
L4/L5
|
48 participants
n=5 Participants
|
11 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Lumbar Level Treated
L5/S1
|
104 participants
n=5 Participants
|
37 participants
n=7 Participants
|
141 participants
n=5 Participants
|
|
Reason for Stopping Injection
Subject Discomfort
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Reason for Stopping Injection
Maximum Pressure Reached
|
91 participants
n=5 Participants
|
6 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Reason for Stopping Injection
Total Available Volume Delivered
|
68 participants
n=5 Participants
|
45 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Reason for Stopping Injection
Other [investigator discretion; saline backflow]
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Maximum Injection Pressure
|
83.0 psi
STANDARD_DEVIATION 29.3 • n=5 Participants
|
49.7 psi
STANDARD_DEVIATION 25.7 • n=7 Participants
|
74.6 psi
STANDARD_DEVIATION 31.9 • n=5 Participants
|
|
Injection Volume
|
2.8 ml
STANDARD_DEVIATION 0.9 • n=5 Participants
|
3.3 ml
STANDARD_DEVIATION 0.8 • n=7 Participants
|
2.9 ml
STANDARD_DEVIATION 0.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: 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).
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.
Outcome measures
| Measure |
BIOSTAT BIOLOGX
n=164 Participants
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
|
Saline
n=56 Participants
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
|
|---|---|---|
|
Subject Composite Success
|
33.5 percentage of subjects
|
39.3 percentage of subjects
|
SECONDARY outcome
Timeframe: 26-weeksPopulation: 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).
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.
Outcome measures
| Measure |
BIOSTAT BIOLOGX
n=164 Participants
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
|
Saline
n=56 Participants
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
|
|---|---|---|
|
Visual Analog Scale for Low Back Pain
|
42.1 percentage of subjects
|
50.0 percentage of subjects
|
SECONDARY outcome
Timeframe: 26-weeksPopulation: 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).
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.
Outcome measures
| Measure |
BIOSTAT BIOLOGX
n=164 Participants
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
|
Saline
n=56 Participants
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
|
|---|---|---|
|
Roland-Morris Disability Questionnaire Score
|
52.4 percentage of subjects
|
50.0 percentage of subjects
|
Adverse Events
BIOSTAT BIOLOGX
Serious events: 22 serious events
Other events: 49 other events
Deaths: 0 deaths
Saline
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BIOSTAT BIOLOGX
n=164 participants at risk
One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
|
Saline
n=56 participants at risk
One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
1.8%
1/56 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Endocrine disorders
Adrenal Mass
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/164 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
1.8%
1/56 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Hepatobiliary disorders
Cholecystitis
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Infections and infestations
Pneumonia
|
1.2%
2/164 • Number of events 2 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/164 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
1.8%
1/56 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.7%
6/164 • Number of events 7 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
1.8%
1/56 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/164 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
1.8%
1/56 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Nervous system disorders
Migraine
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Nervous system disorders
Radiculopathy
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Psychiatric disorders
Completed Suicide
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Psychiatric disorders
Conversion Disorder
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Psychiatric disorders
Delirium
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Psychiatric disorders
Eating Disorder
|
0.00%
0/164 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
1.8%
1/56 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Psychiatric disorders
Substance Abuse
|
0.00%
0/164 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
1.8%
1/56 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
3.6%
2/56 • Number of events 2 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Surgical and medical procedures
Hysterectomy
|
0.61%
1/164 • Number of events 1 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
0.00%
0/56 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
Other adverse events
| Measure |
BIOSTAT BIOLOGX
n=164 participants at risk
One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
|
Saline
n=56 participants at risk
One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.2%
20/164 • Number of events 21 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
5.4%
3/56 • Number of events 3 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Injury, poisoning and procedural complications
Fall
|
7.9%
13/164 • Number of events 14 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
5.4%
3/56 • Number of events 3 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
9.8%
16/164 • Number of events 16 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
5.4%
3/56 • Number of events 4 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
6/164 • Number of events 7 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
3.6%
2/56 • Number of events 3 • 78-weeks postprocedure or until study termination for those subjects not reaching the 78-week follow-up examination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER