Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT (NCT03884283) | Clinical Trial Compass
CompletedNot Applicable
Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT
United States102 participantsStarted 2019-02-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Must be able to comply with the protocol's follow-up schedule.
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.