Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Signed Informed Consent Form. 2. Is at least 18 years of age and skeletally mature. 3. 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. 4. Must have completed a minimum of three months of unsuccessful conservative, non-operative care. 5. DDD and spinal stenosis and/or spondylolisthesis must be confirmed by MRI or CT scans. 6. Must score at least 40 points on the Oswestry Disability Index. 7. Must score at least a 4 on a 10 cm Visual Analog Scale for back or leg pain. 8. Must be able to comply with the protocol's follow-up schedule. 9. Must understand and sign the IRB approved informed consent document.

Exclusion Criteria:

1. Symptomatic at more than two levels. 2. 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). 3. Previous total disc replacement at any lumbar level. 4. Undergoing fusion for recurrent stenosis at the level to be treated. 5. Extraspinal cause of back and/or leg pain, or back and/or leg pain of unknown etiology. 6. Spondylolisthesis not able to be reduced to grade
  • I. 7.
Lumbar scoliosis greater than 11 degrees. 8. Osteoporosis*, osteopenia, osteomalacia, Paget's disease, or metabolic or systemic bone disorders that affect bone or wound healing. 9. Use of posterior instrumentation for stabilization is not possible. 10. Intra-operative soft tissue coverage is not possible. 11. Spinal tumors. 12. Active arachnoiditis. 13. Fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible. 14. Impaired calcium metabolism. 15. Active systemic infection or surgical site infection. 16. Osteomyelitis at the graft site. 17. Rheumatoid arthritis or other autoimmune disease. 18. 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. 19. Systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis. 20. Morbid obesity defined as body mass index (BMI) >40 or a weight more than 100 lbs over ideal body weight. 21. 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. 22. Psychosocial disorders that would preclude accurate evaluation or has a history of recent substance abuse. 23. Active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years. 24. Documented allergies to titanium. 25. 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. 26. Pregnancy/able to become pregnant and not following a reliable contraceptive method, or interested in becoming pregnant in the next two years. 27. Participation in another investigational study within 30 days. 28. Prisoners.

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Prosidyan, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Enrolling by invitation
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis Lumbar

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Long Beach Medical Center, Long Beach, California



Long Beach Medical Center

Long Beach, California, 90806

Memorial Orthopaedic Surgical Group, Long Beach, California



Memorial Orthopaedic Surgical Group

Long Beach, California, 90806

Palm Beach Neurosurgery, Wellington, Florida



Palm Beach Neurosurgery

Wellington, Florida, 33449

Paducah, Kentucky



Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001

Bethesda, Maryland



Washington Spine & Scoliosis Institute at OrthoBethesda

Bethesda, Maryland, 20817

Northwell Health Orthopaedic Institute, Great Neck, New York



Northwell Health Orthopaedic Institute

Great Neck, New York, 11021

KeiperSpine, PC, Eugene, Oregon



KeiperSpine, PC

Eugene, Oregon, 97401

Fort Worth, Texas



Orthopedic and Neurologic Research Institute

Fort Worth, Texas, 76132

University of Virginia Orthopaedics, Charlottesville, Virginia



University of Virginia Orthopaedics

Charlottesville, Virginia, 22903