Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT
Primary Purpose
Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis Lumbar
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FIBERGRAFT BG Matrix
Sponsored by
About this trial
This is an interventional other trial for Degenerative Disc Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Long Beach Medical Center
- Memorial Orthopaedic Surgical Group
- Palm Beach Neurosurgery
- Orthopaedic Institute of Western Kentucky
- Washington Spine & Scoliosis Institute at OrthoBethesda
- Northwell Health Orthopaedic Institute
- KeiperSpine, PC
- Orthopedic and Neurologic Research Institute
- University of Virginia Orthopaedics
Outcomes
Primary Outcome Measures
Spinal fusion
Spinal fusion will be determined via radiographic imaging at 12 months.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03884283
Brief Title
Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT
Official Title
A Post-market, Prospective, Multi-center, Nonrandomized Study to Assess Posterolateral Lumbar Fusions Using FIBERGRAFT BG Matrix
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prosidyan, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis Lumbar
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
FIBERGRAFT BG Matrix
Intervention Description
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)
Primary Outcome Measure Information:
Title
Spinal fusion
Description
Spinal fusion will be determined via radiographic imaging at 12 months.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
Long Beach Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Memorial Orthopaedic Surgical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Palm Beach Neurosurgery
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Orthopaedic Institute of Western Kentucky
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Washington Spine & Scoliosis Institute at OrthoBethesda
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Northwell Health Orthopaedic Institute
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
KeiperSpine, PC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Orthopedic and Neurologic Research Institute
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
University of Virginia Orthopaedics
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT
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