NCT07059065 FIBERGRAFT Aeridyan Posterolateral Fusion Study
| NCT ID | NCT07059065 |
| Status | Recruiting |
| Phase | — |
| Sponsor | DePuy Synthes Products, Inc. |
| Condition | Degenerative Spine Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 316 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 316 participants in total. It began in 2025-08-15 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Kristin Corrado
STUDY CHAIR
DePuy Synthes Products, Inc.
Frequently Asked Questions
Who can join the NCT07059065 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Degenerative Spine Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07059065 currently recruiting?
Yes, NCT07059065 is actively recruiting participants. Contact the research team at kcorrado@its.jnj.com for enrollment information.
Where is the NCT07059065 trial being conducted?
This trial is being conducted at Sacramento, United States, Chicago, United States, Lexington, United States, Boston, United States and 1 additional location.
Who is sponsoring the NCT07059065 clinical trial?
NCT07059065 is sponsored by DePuy Synthes Products, Inc.. The principal investigator is Kristin Corrado at DePuy Synthes Products, Inc.. The trial plans to enroll 316 participants.