RecruitingNot ApplicableNCT07059065

FIBERGRAFT Aeridyan Posterolateral Fusion Study

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

Sponsor

DePuy Synthes Products, Inc.

Enrollment

316 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

Degenerative Spine Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Demineralized Bone Matrix and a medical device called FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute for people with degenerative spine disease. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute

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.

DEVICEDemineralized Bone Matrix

Demineralized Bone Matrix is to be used with bone marrow aspirate and mixed with autograft bone in accordance with approved indications per the IFU

Locations(8)

UC Davis Health System

Sacramento, California, United States

University Of Illinois

Chicago, Illinois, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Brigham And Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Duke University Medical Center

Durham, North Carolina, United States

Rothman Orthopaedics Institute

Philadelphia, Pennsylvania, United States

UT Health Houston

Houston, Texas, United States

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NCT07059065