Spinal InjuriesNCT00387829
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
A study testing DuraGen Plus Adhesion Barrier Matrix in people with Spinal Injuries and Adhesions, run by Integra LifeSciences Corporation at 36 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Injuries, Adhesions
- What is being tested?
- DuraGen Plus Adhesion Barrier Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 36 sitesUnited States
- Study dates
- Oct 2006to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with radicular pain requiring single-level, lumbar hemi-laminectomy or hemilaminotomy procedures with discectomy in the lower lumbar spine
- Require initial open lumbar surgery for extruded, prolapsed or bulging intervertebral discs
- Requires removal of herniated disc fragment
Who cannot join
- Current or historic open traumatic injury to the spine
- Any previous surgery to the lumbar spine or percutaneous tissue destruction or ablation procedures
- Women who are nursing, women who are pregnant and women who are planning to become pregnant during the time of the study
- Any spinal conditions or systemic diseases that would preclude the patient from participation in the clinical trial
- Clinically significant structural disorders
- Known positive for HIV
Show all 9Show fewer
- Insulin-dependent Diabetes Mellitus patients
- Morbid obesity (Body Mass Index greater than or equal to 40 kg/m2)
- History of alcohol or drug abuse within 2 years prior to randomization
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Spine Source
Beverly Hills, California, 90212
University of Virginia
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
Chicago Institute of Neurosurgery and Neuroresearch
Chicago, Illinois, 60640
University of Cincinnati Medical Center / Mayfield Clinic
Cincinnati, Ohio, 45267
Orthopaedic Specialties Spine Center
Clearwater, Florida, 33756
The Cleveland Clinic Spine Institute
Cleveland, Ohio, 44195
Columbia Orthopedic Group
Columbia, Missouri, 65205
Greenwich Neurosurgery/Greenwich Hospital
Greenwich, Connecticut, 06830
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Princeton Brain and Spine Care
Langhorne, Pennsylvania, 19047
William S. Muir, MD, PC
Las Vegas, Nevada, 89169
Bluegrass Orthopedics
Lexington, Kentucky, 40509
Cedars-Sinai Medical Center
Los Angeles, California, 90048
The Back Center
Melbourne, Florida, 32901
University of Miami
Miami, Florida, 33136
Mission Hospital
Mission Viejo, California, 92691
Montana Neuroscience Institute Foundation
Missoula, Montana, 59802
Ronderos Neurosurgery Center, Providence Hospital
Mobile, Alabama, 36608
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, 08901
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Texas Back Institute
Plano, Texas, 75093
Roger Williams Hospital
Providence, Rhode Island, 02908
Virginia Commonwealth University Health System
Richmond, Virginia, 23298
University of California, San Diego
San Diego, California, 92103
Spine Institute
Santa Monica, California, 90404
Southeastern Orthopedic Center
Savannah, Georgia, 31405
Orthopedics Intl.
Seattle, Washington, 98122
Swedish Neuroscience Institute
Seattle, Washington, 98122
Interactive Neuroscience Center
Shreveport, Louisiana, 71119
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
University of South Florida
Tampa, Florida, 33606
Southern California Orthopedic Institute
Van Nuys, California, 91405
Central Ohio Neurological Surgery
Westerville, Ohio, 43081
About this study
Official title: Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy
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.
Read the detailed description
For more information, please visit www.DuragenStudy.com
- Conditions
- Spinal Injuries, Adhesions
- Being tested
- DuraGen Plus Adhesion Barrier Matrix
- Medical subject headings
- Spinal Injuries, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuraGen Plus Adhesion Barrier MatrixDevice
Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine Receives: Device: DuraGen Plus Adhesion Barrier Matrix |
| 2 | No intervention | Control arm is surgery alone (no adhesion barrier) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2010
- Study completionDec 2011
Why it stopped: Sponsor voluntarily terminated study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Benzel, MD, Principal investigator, The Cleveland Clinic Spine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387829
- Sponsor's protocol ID
- DURA-US-2006-1
- Status last verified
- Aug 2017
- First submitted
- 12 Oct 2006
- Last updated
- 7 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy
- ClinicalTrials.gov ID
- NCT00387829
- Acronym / sponsor ID
- DURA-US-2006-1
- Conditions
- Spinal Injuries, Adhesions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor voluntarily terminated study
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Posted 20 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For more information, please visit www.DuragenStudy.com
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: DuraGen Plus Adhesion Barrier MatrixUse of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine |
| 2 | No intervention | –Control arm is surgery alone (no adhesion barrier) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with radicular pain requiring single-level, lumbar hemi-laminectomy or hemilaminotomy procedures with discectomy in the lower lumbar spine
- Require initial open lumbar surgery for extruded, prolapsed or bulging intervertebral discs
- Requires removal of herniated disc fragment
Key exclusion criteria (9 listed)
- Current or historic open traumatic injury to the spine
- Any previous surgery to the lumbar spine or percutaneous tissue destruction or ablation procedures
- Women who are nursing, women who are pregnant and women who are planning to become pregnant during the time of the study
- Any spinal conditions or systemic diseases that would preclude the patient from participation in the clinical trial
- Clinically significant structural disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuraGen Plus Adhesion Barrier MatrixApplication of DuraGen Plus Adhesion Barrier Matrix in spine surgery | Device | 1 |
Primary outcome
Radiological, Pain, and Functional Outcome Assessments
Time frame: 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.
1 secondary outcome
Radiological, Pain, and Functional Outcome Assessments
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Benzel, MD principal investigator
The Cleveland Clinic Spine Institute
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DuraGen Plus Adhesion Barrier Matrix in people with Spinal Injuries and Adhesions, run by Integra LifeSciences Corporation at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological, Pain, and Functional Outcome Assessments (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.