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.
To evaluate radiographic and clinical outcomes of subjects undergoing a 1-3 level instrumented posterior fusion with DePuy Synthes FIBERGRAFT Aeridyan Matrix or Demineralized Bone Matrix in the posterolateral lumbar spine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
316
FIBERGRAFT™ Aeridyan Matrix is a next generation synthetic bone graft that is resorbable, bioactive, and osteoconductive. FIBERGRAFT Aeridyan Matrix is composed of ultra-porous 45S5 bioactive glass granules, boron-based bioactive glass microspheres, and bovine type 1 collagen. The granules are made entirely of 45S5 bioactive glass fibers and feature a porous outer shell encasing an intricate nest of micro- and nano- fibers and microspheres. The nonporous microspheres are made entirely of boron-based bioactive glass and feature essential metallic ions such as zinc, copper, magnesium, and potassium. The highly biocompatible type 1 collagen5 serves as a carrier for the bioactive glass components. FIBERGRAFT Aeridyan Matrix is designed to have an adequate structural integrity for its application as a bone graft substitute material, while optimizing radiopacity and resorption.
Demineralized Bone Matrix is to be used with bone marrow aspirate and mixed with autograft bone in accordance with approved indications per the IFU
UC Davis Health System
Sacramento, California, United States
RECRUITINGUniversity Of Illinois
Chicago, Illinois, United States
RECRUITINGUniversity of Kentucky Medical Center
Lexington, Kentucky, United States
Primary outcome
FIBERGRAFT Aeridyan Matrix percent levels fused at 12 months compared to the grafting control in the posterolateral lumbar spine
Time frame: 12 Months
Secondary Outcome
FIBERGRAFT Aeridyan Matrix clinical outcomes (NRS, ODI) change in baseline to 12 months compared to grafting control
Time frame: 12 Months
Secondary Outcome
FIBERGRAFT Aeridyan Matrix clinical outcomes (NRS, ODI) change in baseline to 24 months compared to grafting control
Time frame: 24 months
Secondary Outcome
FIBERGRAFT Aeridyan Matrix percent levels fused at 6 months compared to the grafting control in the posterolateral lumbar spine
Time frame: 6 months
Secondary Outcome
FIBERGRAFT Aeridyan Matrix percent subjects fused at 6 and at 12 months compared to the grafting control in the posterolateral lumbar spine
Time frame: 6 months and 12 months
Secondary Outcome
Reoperation/Revision rates of FIBERGRAFT Aeridyan Matrix compared to the grafting control
Time frame: Through study completion
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Brigham And Women's Hospital
Boston, Massachusetts, United States
RECRUITINGRothman Orthopaedics Institute
Philadelphia, Pennsylvania, United States
RECRUITING