FIBERGRAFT Aeridyan posterolateral lumbar fusion

A Post-market, Prospective, Controlled, Multicenter Clinical Study to Evaluate Radiographic Fusion of FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute in Subjects Who Undergo a Lumbar Posterolateral Fusion Surgery

This study tests whether FIBERGRAFT Aeridyan Matrix bone graft helps adults having a 1–3 level instrumented lumbar posterolateral fusion achieve solid fusion and similar or better clinical recovery compared with demineralized bone matrix.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 316 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: DePuy Synthes Products, Inc. (Industry-sponsored)
• Locations: 8 sites (Sacramento, California and 7 other locations)
• Trial ID: NCT07059065 on ClinicalTrials.gov

What this trial studies

This is a post-market, prospective, controlled, multicenter study conducted at up to 10 U.S. sites comparing FIBERGRAFT Aeridyan Matrix to demineralized bone matrix in adults undergoing 1–3 level instrumented posterolateral lumbar fusion (with up to two-level posterior lumbar interbody fusion between L1–S1). Participants are enrolled and treated with one of the two graft materials during standard surgical care and followed with radiographic imaging and clinical outcome measures to document fusion and recovery. Key endpoints include radiographic fusion rates and patient clinical outcomes over the follow-up period. The trial excludes patients with prior fusion at the index level, severe osteoporosis or instability, allergy to graft materials, pregnancy, or who require fusion beyond the allowed levels.

Who should consider this trial

Good fit: Adults aged 18 or older who require a 1–3 level instrumented lumbar posterolateral fusion (with up to two-level posterior lumbar interbody fusion between L1 and S1) and can provide informed consent are ideal candidates.

Not a fit: Patients with previous fusion at the index level, severe osteoporosis or instability, known allergy to graft materials, pregnancy, or those needing fusion beyond the allowed levels are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could offer an alternative bone graft option that improves fusion outcomes or reduces complications for patients undergoing lumbar posterolateral fusion.

How similar studies have performed: Demineralized bone matrix is widely used with established clinical experience in posterolateral fusion, while direct comparative data for FIBERGRAFT Aeridyan are limited, making this a relatively novel head-to-head comparison.

Eligibility criteria

INCLUSION CRITERIA

1. 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.
2. Skeletally mature subjects at least 18 years of age at the time of consenting.
3. Willing to provide voluntary written informed consent prior to participation in the clinical study.

EXCLUSION CRITERIA

1. Subjects who had previous fusion surgery at the index level(s).
2. Requiring a Posterolateral Fusion in the lumbar spine at more than three levels and/or an interbody fusion at more than two levels
3. Subjects who have demonstrated allergy or foreign body sensitivity to the implant or graft material.
4. Pregnant subjects or planning to become pregnant within the next 24 months.
5. Subjects diagnosed with severe osteoporosis which may prevent adequate fixation and thus preclude the use of these or any other orthopedic implant.
6. Subjects diagnosed with severe instabilities, vertebral fractures, spinal tumors.
7. 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.
8. Subjects requiring use of an implantable bone graft stimulator or external bone graft stimulator.
9. 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.
10. Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator.
11. Dependency on pharmaceutical drugs, drug abuse, or alcoholism resulting in a lack of subject cooperation.
12. Subjects unable to comply, and/or in the Investigator's opinion unable to comply, with the requirements of participation in the clinical study.
13. Enhanced Demineralized Bone Matrix product for the grafting control used within the posterolateral spine
14. Use of Bone Morphogenetic Protein (BMP) grafting material within the interbody cage(s).
15. Body Mass Index (BMI) ≥ 45
16. Unilateral posterior instrumentation
17. Subject is currently involved in a workers' compensation claim.
18. 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 this trial is running

Sacramento, California and 7 other locations

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

Study contacts

• Study coordinator: Study Contact

Conditions Degenerative Spine Disease