FIBERGRAFT Aeridyan for Degenerative Spine Disease
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Recruiting
N/AInterventional Study
Degenerative Spine Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
316 (estimated)
Sponsor
DePuy Synthes Products, Inc. · Industry
Who this trial is looking for
This trial is looking for adults who need spinal fusion surgery involving 1 to 3 levels of their lower back. Participants will receive a specific bone graft substitute during their surgery and will be monitored for recovery outcomes.
Are You a Good Fit for This Trial?
You may be able to join if
I need a 1-3 level spinal fusion surgery in my lower back.
I am at least 18 years old.
I am willing to sign a consent form to participate.
You may not be able to join if
I have had previous fusion surgery on the same part of my back.
I need spinal fusion at more than three levels.
I am allergic to the implant or graft materials.
I am pregnant or plan to become pregnant in the next 24 months.
I have severe osteoporosis.
I have severe instability, fractures, or tumors in my spine.
I have uncontrolled health problems that could affect my surgery.
I have an infection at the surgery site.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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 t…
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.
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