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 (8) 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
RECRUITING
Sacramento
Illinois
University Of Illinois
RECRUITING
Chicago
Kentucky
University of Kentucky Medical Center
RECRUITING
Lexington
Massachusetts
Brigham And Women's Hospital
RECRUITING
Boston
Minnesota
Mayo Clinic Rochester
NOT_YET_RECRUITING
Rochester
North Carolina
Duke University Medical Center
NOT_YET_RECRUITING
Durham
Pennsylvania
Rothman Orthopaedics Institute
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: 2029-05-31
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.