FIBERGRAFT Aeridyan posterolateral lumbar fusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 Recruiting
• Rothman Orthopaedics Institute
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: kcorrado@its.jnj.com
• Phone: 857-488-0221

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.