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

Completed · Not applicable

Conditions studied: Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis Lumbar

In brief

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.

Key facts

Study ID

NCT03884283

Run by

Prosidyan, Inc.

People needed

102

Starts

2019-02-19

Expected to finish

2023-05-21

Last updated by the study team

2024-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Long Beach Medical Center — Long Beach, California, United States
• Memorial Orthopaedic Surgical Group — Long Beach, California, United States
• Palm Beach Neurosurgery — Wellington, Florida, United States
• Orthopaedic Institute of Western Kentucky — Paducah, Kentucky, United States
• Washington Spine & Scoliosis Institute at OrthoBethesda — Bethesda, Maryland, United States
• Northwell Health Orthopaedic Institute — Great Neck, New York, United States
• KeiperSpine, PC — Eugene, Oregon, United States
• Orthopedic and Neurologic Research Institute — Fort Worth, Texas, United States
• University of Virginia Orthopaedics — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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