FIBERGRAFT for Degenerative Spine Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a special bone graft called FIBERGRAFT™ Aeridyan Matrix to assist individuals with degenerative spine disease. The goal is to evaluate how effectively this bone graft aids in bone fusion after spine surgery. Participants will be divided into groups to receive either the FIBERGRAFT™ or a different material for comparison. Individuals needing spine surgery on 1 to 3 levels in the lower back, without prior surgery on those areas, may qualify. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance spine surgery outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that the FIBERGRAFT™ Aeridyan Matrix bone graft substitute is safe for use in lumbar fusion surgeries?
Research has shown that FIBERGRAFT™ Aeridyan Matrix is generally safe for people. The FDA has approved this bone graft substitute for use in spine surgeries to fill bone gaps, indicating its safety in past applications. The product contains materials such as boron-based bioactive glass, magnesium, and zinc, which support bone health.
Although specific side effects from the studies are not detailed, the FDA's approval for other uses suggests that serious side effects are likely rare or manageable. Participants in any clinical study should consult their doctor about potential risks.12345Why are researchers excited about this trial?
Researchers are excited about FIBERGRAFT™ Aeridyan Matrix because it offers a novel approach to treating degenerative spine disease. Unlike traditional bone grafts, such as autografts or allografts, FIBERGRAFT uses a synthetic matrix designed to mimic the natural bone structure, which may enhance bone growth and healing. This innovative matrix structure could lead to faster recovery times and improved fusion outcomes compared to standard treatments. Additionally, since it's a synthetic option, it eliminates the need for bone harvesting from the patient, reducing surgery time and potential complications.
What evidence suggests that this trial's treatments could be effective for degenerative spine disease?
Research has shown that FIBERGRAFT Aeridyan Matrix holds promise for people with degenerative spine disease. One study found a 96.3% success rate in helping bones grow together to form a strong, stable structure. Strong bone fusion is important because it can reduce pain and improve spine stability. In this trial, participants in Cohorts A and B will receive the FIBERGRAFT Aeridyan Matrix bone graft substitute. The treatment uses special glass fibers to promote bone growth. These positive results suggest FIBERGRAFT could be effective for those needing lumbar spine fusion surgery.12567
Who Is on the Research Team?
Kristin Corrado
Principal Investigator
DePuy Synthes Products, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with degenerative spine disease who are undergoing 1-3 level instrumented lumbar posterolateral fusion surgery. Specific eligibility details aren't provided, but typically participants must meet certain health criteria and not have conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 1-3 level instrumented lumbar posterolateral fusion surgery using FIBERGRAFT Aeridyan Matrix or Demineralized Bone Matrix
Follow-up
Participants are monitored for radiographic fusion and clinical outcomes, including reoperation/revision rates
What Are the Treatments Tested in This Trial?
Interventions
- FIBERGRAFT™ Aeridyan Matrix
Trial Overview
The study is testing FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute against Demineralized Bone Matrix to see which one works better for spinal fusion surgery. It's a controlled study, meaning there will be a comparison group, conducted across up to 10 sites in the U.S.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Arm 2: 79 subjects (Cohort B) treated with FIBERGRAFT Aeridyan Matrix bone graft substitute in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1. Cohort B will have a score range of 14.6 - 43.5
Arm 1: 79 subjects (Cohort A) treated with FIBERGRAFT Aeridyan Matrix bone graft substitute in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1. Cohort A will have a score range of 6 - 14.5
Arm 3: 79 subjects (Cohort A) treated with Demineralized Bone Matrix in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1. Cohort A will have a score range of 6 - 14.5
Arm 4: 79 subjects (Cohort B) treated with Demineralized Bone Matrix in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1. Cohort B will have a score range of 14.6 - 43.5
Find a Clinic Near You
Who Is Running the Clinical Trial?
DePuy Synthes Products, Inc.
Lead Sponsor
Citations
FIBERGRAFT Aeridyan Posterolateral Fusion Study
This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan ...
FIBERGRAFT Aeridyan Posterolateral Fusion Study - Arthritis ...
This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan Matrix ...
FIBERGRAFT Aeridyan Posterolateral Fusion Study
This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan ...
FIBERGRAFT Aeridyan Posterolateral Fusion Study
The surgery involves joining two or three bones in the lower back to reduce pain and improve stability in people with degenerative spine disease. The study ...
5.
orthospinenews.com
orthospinenews.com/2021/08/26/prosidyan-fibergraft-achieves-high-fusion-rate-in-multi-center-clinical-study-presented-at-top-neurosurgery-conference/Prosidyan® FIBERGRAFT® Achieves High Fusion Rate in ...
Prosidyan's bioactive glass fiber-based bone graft substitute achieved a successful 96.3% fusion outcome in a multi-center clinical evaluation.
FIBERGRAFT™ AERIDYAN™ Matrix | Products - J&J MedTech
The FIBERGRAFT™ AERIDYAN™ Matrix is the first bone graft substitute that contains boron-based bioactive glass with essential elements (magnesium, zinc, ...
K182670.pdf - accessdata.fda.gov
FIBERGRAFT® AERIDYAN Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These ...
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