NCT07059065 · DePuy Synthes Products, Inc.
FIBERGRAFT Aeridyan Posterolateral Fusion Study
What this study is about
This is a post-market, forward-looking, controlled, conducted at multiple hospitals 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects 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 subjects 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.
Exclusion criteria
- Subjects 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
- Subjects who have demonstrated allergy or foreign body sensitivity to the implant or graft material.
- Pregnant subjects or planning to become pregnant within the next 24 months.
- Subjects diagnosed with severe osteoporosis which may prevent adequate fixation and thus preclude the use of these or any other orthopedic implant.
- Subjects diagnosed with severe instabilities, vertebral fractures, spinal tumors.
- Subjects 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.
- Subjects requiring use of an implantable bone graft stimulator or external bone graft stimulator.
- Subjects 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.
- Subjects 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 interventional clinical trial within the last 6 months or plans to participate in an interventional clinical trial within the next 24 months.
Where
- Sacramento, California
- Chicago, Illinois
- Lexington, Kentucky
- Boston, Massachusetts
- Rochester, Minnesota
- Durham, North Carolina
- Philadelphia, Pennsylvania
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations