Trial Outcomes & Findings for DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery (NCT NCT00387829)
NCT ID: NCT00387829
Last Updated: 2017-09-07
Results Overview
Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage). Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain. Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))\*100.
TERMINATED
NA
347 participants
6 months
2017-09-07
Participant Flow
A total of 343 patients were randomized in the study (Intent-to-treat population). Four patients received treatment (1 Duragen Plus; 3 Surgery alone), but were not randomized correctly, and were followed-up for safety only. Hence the total patients in the Safety Population is 347.
Participant milestones
| Measure |
1- DuraGen Plus During Surgery
Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
|
2 - Surgery Alone
Control arm is surgery alone (no adhesion barrier)
|
|---|---|---|
|
Safety Population
STARTED
|
178
|
169
|
|
Safety Population
COMPLETED
|
139
|
136
|
|
Safety Population
NOT COMPLETED
|
39
|
33
|
|
Intent-to-treat Population
STARTED
|
177
|
166
|
|
Intent-to-treat Population
COMPLETED
|
139
|
136
|
|
Intent-to-treat Population
NOT COMPLETED
|
38
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
Baseline characteristics by cohort
| Measure |
1- DuraGen Plus During Surgery
n=177 Participants
Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
|
2 - Surgery Alone
n=166 Participants
Control arm is surgery alone (no adhesion barrier)
|
Total
n=343 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
171 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
333 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 11.38 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 11.27 • n=7 Participants
|
43.0 years
STANDARD_DEVIATION 11.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
177 participants
n=5 Participants
|
166 participants
n=7 Participants
|
343 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data reported for patients evaluable at 6 months.
Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage). Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain. Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))\*100.
Outcome measures
| Measure |
1- DuraGen Plus During Surgery
n=147 Participants
Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
|
2 - Surgery Alone
n=136 Participants
Control arm is surgery alone (no adhesion barrier)
|
|---|---|---|
|
Radiological, Pain, and Functional Outcome Assessments
MRI Outcome Score
|
12.375 Outcome scores
Standard Error 0.499
|
12.578 Outcome scores
Standard Error 0.517
|
|
Radiological, Pain, and Functional Outcome Assessments
ODI Score
|
6.974 Outcome scores
Standard Error 0.629
|
7.118 Outcome scores
Standard Error 0.639
|
|
Radiological, Pain, and Functional Outcome Assessments
VAS Score
|
14.010 Outcome scores
Standard Error 1.610
|
16.696 Outcome scores
Standard Error 1.646
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data reported for patients evaluable at 12 months.
Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage). Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain. Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))\*100.
Outcome measures
| Measure |
1- DuraGen Plus During Surgery
n=133 Participants
Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
|
2 - Surgery Alone
n=127 Participants
Control arm is surgery alone (no adhesion barrier)
|
|---|---|---|
|
Radiological, Pain, and Functional Outcome Assessments
MRI Outcome Score
|
10.046 Outcome scores
Standard Error 0.519
|
9.788 Outcome scores
Standard Error 0.534
|
|
Radiological, Pain, and Functional Outcome Assessments
ODI Score
|
6.048 Outcome scores
Standard Error 0.625
|
6.890 Outcome scores
Standard Error 0.633
|
|
Radiological, Pain, and Functional Outcome Assessments
VAS Score
|
12.926 Outcome scores
Standard Error 1.612
|
14.378 Outcome scores
Standard Error 1.633
|
Adverse Events
1- DuraGen Plus During Surgery
2 - Surgery Alone
Serious adverse events
| Measure |
1- DuraGen Plus During Surgery
n=178 participants at risk
Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
|
2 - Surgery Alone
n=169 participants at risk
Control arm is surgery alone (no adhesion barrier)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Inververtebral disc protrusion
|
4.5%
8/178 • Number of events 8
|
5.3%
9/169 • Number of events 9
|
|
Nervous system disorders
Headache
|
1.1%
2/178 • Number of events 2
|
0.59%
1/169 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/178
|
0.59%
1/169 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.56%
1/178 • Number of events 1
|
0.00%
0/169
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/178
|
1.2%
2/169 • Number of events 2
|
|
Cardiac disorders
Cardiac failure congestive
|
0.56%
1/178 • Number of events 1
|
0.00%
0/169
|
|
Cardiac disorders
Sinus bradycardia
|
0.56%
1/178 • Number of events 1
|
0.00%
0/169
|
|
Gastrointestinal disorders
Faeces Discouloured
|
0.00%
0/178
|
0.59%
1/169 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intracranial hypotension
|
0.56%
1/178 • Number of events 1
|
0.59%
1/169 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.56%
1/178 • Number of events 1
|
0.00%
0/169
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.56%
1/178 • Number of events 1
|
0.59%
1/169 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Cervial spinal stenosis
|
0.56%
1/178 • Number of events 1
|
0.00%
0/169
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.56%
1/178 • Number of events 1
|
0.00%
0/169
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.56%
1/178 • Number of events 1
|
0.00%
0/169
|
|
Musculoskeletal and connective tissue disorders
Post laminectomy syndrome
|
0.00%
0/178
|
0.59%
1/169 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.00%
0/178
|
0.59%
1/169 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/178
|
0.59%
1/169 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.56%
1/178 • Number of events 1
|
0.00%
0/169
|
|
Psychiatric disorders
Depression
|
0.56%
1/178 • Number of events 1
|
0.00%
0/169
|
|
Renal and urinary disorders
Unirary retention
|
0.00%
0/178
|
0.59%
1/169 • Number of events 1
|
|
Vascular disorders
Arterial haemorrhage
|
0.56%
1/178 • Number of events 1
|
0.00%
0/169
|
|
Vascular disorders
Leriche syndrome
|
0.56%
1/178 • Number of events 1
|
0.00%
0/169
|
Other adverse events
| Measure |
1- DuraGen Plus During Surgery
n=178 participants at risk
Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
|
2 - Surgery Alone
n=169 participants at risk
Control arm is surgery alone (no adhesion barrier)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.8%
5/178 • Number of events 8
|
3.6%
6/169 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
11/178 • Number of events 11
|
3.6%
6/169 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.5%
33/178 • Number of events 35
|
21.3%
36/169 • Number of events 43
|
|
Musculoskeletal and connective tissue disorders
Inververtebral disc protrusion
|
9.0%
16/178 • Number of events 16
|
7.7%
13/169 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.9%
7/178 • Number of events 7
|
7.1%
12/169 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Pain in extremety
|
9.6%
17/178 • Number of events 20
|
9.5%
16/169 • Number of events 23
|
|
Nervous system disorders
Headache
|
2.2%
4/178 • Number of events 5
|
4.1%
7/169 • Number of events 9
|
|
Nervous system disorders
Hypoaesthesia
|
3.9%
7/178 • Number of events 7
|
5.9%
10/169 • Number of events 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60