FIBERGRAFT Aeridyan Posterolateral Fusion Study
ConditionDegenerative Spine Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDePuy Synthes Products, Inc.
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.
Eligibility criteria
Qualifiers
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.
Skeletally mature subjects at least 18 years of age at the time of consenting.
Willing to provide voluntary written informed consent prior to participation in the clinical study.
Disqualifiers
Subjects who had previous fusion surgery at the index level(s).
Requiring a Posterolateral Fusion in the lumbar spine at more than three levels and/or an interbody fusion at more than two levels
Subjects who have demonstrated allergy or foreign body sensitivity to the implant or graft material.
Pregnant subjects or planning to become pregnant within the next 24 months.
Trial design
Treatments tested in this trial
- FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute
- Demineralized Bone Matrix
Treatment groups
316 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov