Degenerative Disc DiseaseNCT03884283
Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT
A study testing FIBERGRAFT BG Matrix in people with Degenerative Disc Disease and Spondylolisthesis, run by Prosidyan, Inc. at 9 sites in United States.
Trial summary
This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed with autograft and bone marrow aspirate in up to 150 subjects with degenerative disc disease (DDD) with or without radiculopathy, or spinal stenosis and/or spondylolisthesis… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis Lumbar
- What is being tested?
- FIBERGRAFT BG Matrix
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Feb 2019to 21 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Is at least 18 years of age and skeletally mature.
- Must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc disease (DDD) at one or two adjacent levels from L2-S1, requiring a fusion.
- Must have completed a minimum of three months of unsuccessful conservative, non-operative care.
- DDD and spinal stenosis and/or spondylolisthesis must be confirmed by MRI or CT scans.
- Must score at least 40 points on the Oswestry Disability Index.
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- Must score at least a 4 on a 10 cm Visual Analog Scale for back or leg pain.
- Must be able to comply with the protocol's follow-up schedule.
- Must understand and sign the IRB approved informed consent document.
Who cannot join
- Symptomatic at more than two levels.
- Previous fusion surgery at any lumbar level with or without instrumentation (prior discectomy, laminotomy, laminectomy or nucleolysis at the index level (> 6 months) is permitted).
- Previous total disc replacement at any lumbar level.
- Undergoing fusion for recurrent stenosis at the level to be treated.
- Extraspinal cause of back and/or leg pain, or back and/or leg pain of unknown etiology.
- Spondylolisthesis not able to be reduced to grade I.
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- Lumbar scoliosis greater than 11 degrees.
- Osteoporosis*, osteopenia, osteomalacia, Paget's disease, or metabolic or systemic bone disorders that affect bone or wound healing.
- Use of posterior instrumentation for stabilization is not possible.
- Intra-operative soft tissue coverage is not possible.
- Spinal tumors.
- Active arachnoiditis.
- Fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
- Impaired calcium metabolism.
- Active systemic infection or surgical site infection.
- Osteomyelitis at the graft site.
- Rheumatoid arthritis or other autoimmune disease.
- Chronic steroid use (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing.
- Systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis.
- Morbid obesity defined as body mass index (BMI) >40 or a weight more than 100 lbs over ideal body weight.
- Smokers unless the subject agrees to quit at least 2 weeks prior to and for the duration of the study, confirmed by a carboxyhemoglobin test prior to surgery.
- Psychosocial disorders that would preclude accurate evaluation or has a history of recent substance abuse.
- Active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years.
- Documented allergies to titanium.
- Subjects with a history of anaphylaxis, history of multiple allergies, known allergies to bovine collagen, or who are being treated for desensitization to meat products because FIBERGRAFT® BG Matrix contains bovine collagen.
- Pregnancy/able to become pregnant and not following a reliable contraceptive method, or interested in becoming pregnant in the next two years.
- Participation in another investigational study within 30 days.
- Prisoners.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Washington Spine & Scoliosis Institute at OrthoBethesda
Bethesda, Maryland, 20817
University of Virginia Orthopaedics
Charlottesville, Virginia, 22903
KeiperSpine, PC
Eugene, Oregon, 97401
Orthopedic and Neurologic Research Institute
Fort Worth, Texas, 76132
Northwell Health Orthopaedic Institute
Great Neck, New York, 11021
Long Beach Medical Center
Long Beach, California, 90806
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
Palm Beach Neurosurgery
Wellington, Florida, 33449
About this study
Official title: A Post-market, Prospective, Multi-center, Nonrandomized Study to Assess Posterolateral Lumbar Fusions Using FIBERGRAFT BG Matrix
This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed with autograft and bone marrow aspirate in up to 150 subjects with degenerative disc disease (DDD) with or without radiculopathy, or spinal stenosis and/or spondylolisthesis requiring a fusion. The patient population will include adult (skeletally mature) men and women undergoing 1 or 2 level fusion in the lumbar spine (L2-S1) who are deemed eligible for the study, characterized by inclusion and exclusion criteria.
- Being tested
- FIBERGRAFT BG Matrix
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIBERGRAFT BG MatrixDevice
Subjects who meet the criteria for entrance into the study will undergo posterolateral fusion using FIBERGRAFT® BG Matrix in combination with autograft and bone marrow aspirate (BMA)
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal fusion
Spinal fusion will be determined via radiographic imaging at 12 months.
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 posted21 Mar 2019
- Study start19 Feb 2019
- Primary completion21 May 2023
- Study completion21 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prosidyan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884283
- Sponsor's protocol ID
- CD0001
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2019
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Prospective, Multi-center, Nonrandomized Study to Assess Posterolateral Lumbar Fusions Using FIBERGRAFT BG Matrix
- ClinicalTrials.gov ID
- NCT03884283
- Acronym / sponsor ID
- CD0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Prosidyan, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 21 May 2023 (actual)
- Study completion
- 21 May 2023 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed with autograft and bone marrow aspirate in up to 150 subjects with degenerative disc disease (DDD) with or without radiculopathy, or spinal stenosis and/or spondylolisthesis requiring a fusion. The patient population will include adult (skeletally mature) men and women undergoing 1 or 2 level fusion in the lumbar spine (L2-S1) who are deemed eligible for the study, characterized by inclusion and exclusion criteria.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed Informed Consent Form
- Is at least 18 years of age and skeletally mature.
- Must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc disease (DDD) at one or two adjacent levels from L2-S1, requiring a fusion.
- Must have completed a minimum of three months of unsuccessful conservative, non-operative care.
- DDD and spinal stenosis and/or spondylolisthesis must be confirmed by MRI or CT scans.
Key exclusion criteria (28 listed)
- Symptomatic at more than two levels.
- Previous fusion surgery at any lumbar level with or without instrumentation (prior discectomy, laminotomy, laminectomy or nucleolysis at the index level (> 6 months) is permitted).
- Previous total disc replacement at any lumbar level.
- Undergoing fusion for recurrent stenosis at the level to be treated.
- Extraspinal cause of back and/or leg pain, or back and/or leg pain of unknown etiology.
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 |
|---|---|---|
| FIBERGRAFT BG MatrixSubjects who meet the criteria for entrance into the study will undergo posterolateral fusion using FIBERGRAFT® BG Matrix in combination with autograft and bone marrow aspirate (BMA) | Device | – |
Primary outcome
Spinal fusion
Time frame: 12 months
Spinal fusion will be determined via radiographic imaging at 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIBERGRAFT BG Matrix in people with Degenerative Disc Disease and Spondylolisthesis, run by Prosidyan, Inc. at 9 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 9 inclusion and 28 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: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Spinal fusion (time frame: 12 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 22 Apr 2024.