FIBERGRAFT Aeridyan for Degenerative Spine Disease

FIBERGRAFT Aeridyan Posterolateral Fusion Study

Recruiting N/A Interventional 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.

Check Your Eligibility
About This Trial

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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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…
Contacts

Study Contact

857-488-0221

kcorrado@its.jnj.com

CONTACT

Kristin Corrado, B.S

kcorrado@its.jnj.com

CONTACT