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Sponsor voluntarily terminated study
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To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care.
For more information, please visit www.DuragenStudy.com
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine |
|
| 2 | No Intervention | Control arm is surgery alone (no adhesion barrier) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DuraGen Plus Adhesion Barrier Matrix | Device | Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiological, Pain, and Functional Outcome Assessments | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological, Pain, and Functional Outcome Assessments | 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. |
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Inclusion Criteria (Abstracted from clinical protocol):
Exclusion Criteria (Abstracted from clinical protocol):
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| Name | Affiliation | Role |
|---|---|---|
| Edward Benzel, MD | The Cleveland Clinic Spine Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronderos Neurosurgery Center, Providence Hospital | Mobile | Alabama | 36608 | United States | ||
| Spine Source |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1- DuraGen Plus During Surgery | Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine |
| FG001 | 2 - Surgery Alone | Control arm is surgery alone (no adhesion barrier) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Safety Population |
|
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| 12 months |
| Beverly Hills |
| California |
| 90212 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Mission Hospital | Mission Viejo | California | 92691 | United States |
| University of California, San Diego | San Diego | California | 92103 | United States |
| Spine Institute | Santa Monica | California | 90404 | United States |
| Southern California Orthopedic Institute | Van Nuys | California | 91405 | United States |
| Greenwich Neurosurgery/Greenwich Hospital | Greenwich | Connecticut | 06830 | United States |
| Orthopaedic Specialties Spine Center | Clearwater | Florida | 33756 | United States |
| The Back Center | Melbourne | Florida | 32901 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Tallahassee Neurological Clinic | Tallahassee | Florida | 32308 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Southeastern Orthopedic Center | Savannah | Georgia | 31405 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Chicago Institute of Neurosurgery and Neuroresearch | Chicago | Illinois | 60640 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Bluegrass Orthopedics | Lexington | Kentucky | 40509 | United States |
| Interactive Neuroscience Center | Shreveport | Louisiana | 71119 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Columbia Orthopedic Group | Columbia | Missouri | 65205 | United States |
| Montana Neuroscience Institute Foundation | Missoula | Montana | 59802 | United States |
| William S. Muir, MD, PC | Las Vegas | Nevada | 89169 | United States |
| University of Medicine and Dentistry of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| University of Cincinnati Medical Center / Mayfield Clinic | Cincinnati | Ohio | 45267 | United States |
| The Cleveland Clinic Spine Institute | Cleveland | Ohio | 44195 | United States |
| Central Ohio Neurological Surgery | Westerville | Ohio | 43081 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Princeton Brain and Spine Care | Langhorne | Pennsylvania | 19047 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Roger Williams Hospital | Providence | Rhode Island | 02908 | United States |
| Texas Back Institute | Plano | Texas | 75093 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Virginia Commonwealth University Health System | Richmond | Virginia | 23298 | United States |
| Orthopedics Intl. | Seattle | Washington | 98122 | United States |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| Intent-to-treat Population |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1- DuraGen Plus During Surgery | Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine |
| BG001 | 2 - Surgery Alone | Control arm is surgery alone (no adhesion barrier) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiological, Pain, and Functional Outcome Assessments | 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. | Data reported for patients evaluable at 6 months. | Posted | Least Squares Mean | Standard Error | Outcome scores | 6 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Radiological, Pain, and Functional Outcome Assessments | 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. | Data reported for patients evaluable at 12 months. | Posted | Least Squares Mean | Standard Error | Outcome scores | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1- DuraGen Plus During Surgery | Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine | 18 | 178 | 100 | 178 | ||
| EG001 | 2 - Surgery Alone | Control arm is surgery alone (no adhesion barrier) | 19 | 169 | 106 | 169 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inververtebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Faeces Discouloured | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intracranial hypotension | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Skin laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Cervial spinal stenosis | Musculoskeletal and connective tissue disorders |
| |||
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders |
| |||
| Neck Pain | Musculoskeletal and connective tissue disorders |
| |||
| Post laminectomy syndrome | Musculoskeletal and connective tissue disorders |
| |||
| Spinal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Testis cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Depression | Psychiatric disorders |
| |||
| Unirary retention | Renal and urinary disorders |
| |||
| Arterial haemorrhage | Vascular disorders |
| |||
| Leriche syndrome | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Inververtebral disc protrusion | Musculoskeletal and connective tissue disorders |
| |||
| Muscle Spasms | Musculoskeletal and connective tissue disorders |
| |||
| Pain in extremety | Musculoskeletal and connective tissue disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Hypoaesthesia | Nervous system disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Affairs | Intergra LifeSciences | 609-275-0500 | clinicalaffairs-neuro@integralife.com |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
|
| Male |
|
| VAS Score |
|
| Counts |
|---|
| Participants |
|
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