A Post-market, Prospective, Controlled, Multicenter Clinical Study to Evaluate Radiographic Fusion of FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute in Subjects Who Undergo a Lumbar Posterolateral Fusion Surgery
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
UC Davis Health System
NOT_YET_RECRUITING
Sacramento
Illinois
University Of Illinois
RECRUITING
Chicago
Kentucky
UK Health Care Kentucky Neuroscience Institute
RECRUITING
Lexington
Massachusetts
Brigham And Women's Hospital
NOT_YET_RECRUITING
Boston
North Carolina
Duke University Medical Center
NOT_YET_RECRUITING
Durham
Pennsylvania
Rothman Orthopaedics Institute
NOT_YET_RECRUITING
Philadelphia
Texas
UT Health Houston
NOT_YET_RECRUITING
Houston
Contact Information
Primary
Study Contact
kcorrado@its.jnj.com
857-488-0221
Backup
Kristin Corrado, B.S
kcorrado@its.jnj.com
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2028-12-29
Participants
Target number of participants: 316
Treatments
Experimental: Cohort A)
Arm 1: 79 subjects (Cohort A) treated with FIBERGRAFT Aeridyan Matrix bone graft substitute in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1.~Cohort A will have a score range of 6 - 14.5
Experimental: Cohort B
Arm 2: 79 subjects (Cohort B) treated with FIBERGRAFT Aeridyan Matrix bone graft substitute in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1.~Cohort B will have a score range of 14.6 - 43.5
Active_comparator: Controlled Cohort A
Arm 3: 79 subjects (Cohort A) treated with Demineralized Bone Matrix in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1.~Cohort A will have a score range of 6 - 14.5
Active_comparator: Controlled Cohort B
Arm 4: 79 subjects (Cohort B) treated with Demineralized Bone Matrix in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1.~Cohort B will have a score range of 14.6 - 43.5
Related Therapeutic Areas
Sponsors
Leads: DePuy Synthes Products, Inc.