FIBERGRAFT Aeridyan Posterolateral Fusion Study

Recruiting now · Not applicable

Conditions studied: Degenerative Spine Disease

In brief

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.

Key facts

Study ID

NCT07059065

Run by

DePuy Synthes Products, Inc.

People needed

316

Starts

2025-08-15

Expected to finish

2029-07-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• University of Kentucky Medical Center — Lexington, Kentucky, United States (enrolling)
• Rothman Orthopaedics Institute — Philadelphia, Pennsylvania, United States (enrolling)
• UC Davis Health System — Sacramento, California, United States (enrolling)
• Brigham And Women's Hospital — Boston, Massachusetts, United States (enrolling)
• University Of Illinois — Chicago, Illinois, United States (enrolling)
• UT Health Houston — Houston, Texas, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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