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New treatment option for Degenerative Spine Disease
Official title FIBERGRAFT Aeridyan Posterolateral Fusion Study
ClinicalTrials.gov ID: NCT07059065
What this study is testing
- What it's testing
- This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan Matrix bone graft substitute in subjects who undergo a 1-3 level instrumented lumbar posterolateral fusion surgery. This clinical study will be conducted at up to 10 clinical sites within the United States.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people who require a 1-3 level instrumented PLF fusion in the lumbar spine in conjunction with a 1 to 2 consecutive level posterior lumbar interbody...
- Skeletally mature people at least 18 years of age at the time of consenting.
- Willing to provide voluntary written informed consent prior to participation in the clinical study.
You likely can't join if
- people who had previous fusion surgery at the index level(s).
- Requiring a Posterolateral Fusion in the lumbar spine at more than three levels and/or an interbody fusion at more than two levels
- people who have demonstrated allergy or foreign body sensitivity to the implant or graft material.
- Pregnant people or planning to become pregnant within the next 24 months.
- people diagnosed with severe osteoporosis which may prevent adequate fixation and thus preclude the use of these or any other orthopedic implant.
- people diagnosed with severe instabilities, vertebral fractures, spinal tumors.
See the full eligibility criteria
- people who require a 1-3 level instrumented PLF fusion in the lumbar spine in conjunction with a 1 to 2 consecutive level posterior lumbar interbody fusion procedure between L1-S1.
- Skeletally mature people at least 18 years of age at the time of consenting.
- Willing to provide voluntary written informed consent prior to participation in the clinical study.
- people who had previous fusion surgery at the index level(s).
- Requiring a Posterolateral Fusion in the lumbar spine at more than three levels and/or an interbody fusion at more than two levels
- people who have demonstrated allergy or foreign body sensitivity to the implant or graft material.
- Pregnant people or planning to become pregnant within the next 24 months.
- people diagnosed with severe osteoporosis which may prevent adequate fixation and thus preclude the use of these or any other orthopedic implant.
- people diagnosed with severe instabilities, vertebral fractures, spinal tumors.
- people who have an uncontrolled systemic or metabolic disease which, in the Investigator's opinion, would compromise their health, safety, or ability to participate or follow-up in this clinical study.
- people requiring use of an implantable bone graft stimulator or external bone graft stimulator.
- people that have infection or osteomyelitis at the graft site. Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator.
- Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator.
- Dependency on pharmaceutical drugs, drug abuse, or alcoholism resulting in a lack of subject cooperation.
- people unable to comply, and/or in the Investigator's opinion unable to comply, with the requirements of participation in the clinical study.
- Enhanced Demineralized Bone Matrix product for the grafting control used within the posterolateral spine
- Use of Bone Morphogenetic Protein (BMP) grafting material within the interbody cage(s).
- Body Mass Index (BMI) ≥ 45
- Unilateral posterior instrumentation
- Subject is currently involved in a workers' compensation claim.
- Subject has participated in an treatment clinical trial within the last 6 months or plans to participate in an treatment clinical trial within the next 24 months.
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Chicago, Illinois, United States; Lexington, Kentucky, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; Durham, North Carolina, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.