Actively Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Led by DePuy Synthes Products, Inc. · Updated on 2026-05-08
316
Participants Needed
8
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Require 1-3 level instrumented posterolateral lumbar fusion with 1-2 level posterior lumbar interbody fusion between L1-S1
- Skeletally mature and at least 18 years old at consent
- Willing to provide written informed consent before joining the study
You will not qualify if you...
- Previous fusion surgery at the treatment level(s)
- Need posterolateral fusion at more than 3 levels or interbody fusion at more than 2 levels
- Allergy or sensitivity to implant or graft materials
- Pregnant or planning pregnancy within 24 months
- Severe osteoporosis that prevents implant fixation
- Severe spine instabilities, vertebral fractures, or spinal tumors
- Uncontrolled systemic or metabolic disease affecting health or study participation
- Require implantable or external bone graft stimulators
- Infection or osteomyelitis at the graft site
- Any medical or surgical condition that prevents benefit from spinal surgery
- Dependence on drugs, drug abuse, or alcoholism affecting cooperation
- Unable to comply with study requirements
- Use of enhanced Demineralized Bone Matrix for grafting control
- Use of Bone Morphogenetic Protein grafting material in interbody cages
- Body Mass Index of 45 or higher
- Unilateral posterior instrumentation
- Involved in a workers' compensation claim
- Participation in another interventional clinical trial within the past 6 months or planned within 24 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
UC Davis Health System
Sacramento, California, United States, 95816
Actively Recruiting
2
University Of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
3
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
4
Brigham And Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
5
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
6
Duke University Medical Center
Durham, North Carolina, United States, 27710
Not Yet Recruiting
7
Rothman Orthopaedics Institute
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
8
UT Health Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
S
Study Contact
CONTACT
K
Kristin Corrado, B.S
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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