FIBERGRAFT Aeridyan Posterolateral Fusion Study

NCT07059065 | Recruiting FDA Device

• 1 other identifier: DSS202303
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Degenerative Spine Disease

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  FIBERGRAFT Aeridyan Matrix percent levels fused at 12 months compared to the grafting control in the posterolateral lumbar spine

  12 Months

Secondary Outcomes (5)

• Secondary Outcome

  12 Months

• Secondary Outcome

  24 months

• Secondary Outcome

  6 months

• Secondary Outcome

  6 months and 12 months

• Secondary Outcome

  Through study completion

Other Outcomes (4)

• Exploratory Endpoint

  6 months

• Exploratory Endpoint

  12 Months

• Exploratory Endpoint

  6 months

Study Arms (4)

Cohort A)

EXPERIMENTAL

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

Device: FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute

Cohort B

EXPERIMENTAL

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

Device: FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute

Controlled Cohort A

ACTIVE COMPARATOR

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

Device: Demineralized Bone Matrix

Controlled Cohort B

ACTIVE COMPARATOR

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

Device: Demineralized Bone Matrix

Interventions

Demineralized Bone Matrix DEVICE

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

Controlled Cohort A; Controlled Cohort B

FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute DEVICE

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.

Cohort A); Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects diagnosed with severe osteoporosis which may prevent adequate fixation and thus preclude the use of these or any other orthopedic implant.
• Subjects diagnosed with severe instabilities, vertebral fractures, spinal tumors.
• Subjects who have an uncontrolled systemic or metabolic disease which, in the Investigator's opinion, would compromise their health, safety, or ability to participate or follow-up in this clinical study.
• Subjects requiring use of an implantable bone graft stimulator or external bone graft stimulator.
• Subjects that have infection or osteomyelitis at the graft site. Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator.
• Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator.
• Dependency on pharmaceutical drugs, drug abuse, or alcoholism resulting in a lack of subject cooperation.
• Subjects unable to comply, and/or in the Investigator's opinion unable to comply, with the requirements of participation in the clinical study.
• Enhanced Demineralized Bone Matrix product for the grafting control used within the posterolateral spine
• Use of Bone Morphogenetic Protein (BMP) grafting material within the interbody cage(s).
• Body Mass Index (BMI) ≥ 45

Sponsors & Collaborators

• DePuy Synthes Products, Inc.: lead

Study Sites (8)

UC Davis Health System

Sacramento, California, 95816, United States

RECRUITING

University Of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

RECRUITING

Brigham And Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Rothman Orthopaedics Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

UT Health Houston

Houston, Texas, 77030, United States

NOT YET RECRUITING

Study Officials

• Kristin Corrado

  DePuy Synthes Products, Inc.

  STUDY CHAIR

Central Study Contacts

Study Contact

CONTACT

857-488-0221; kcorrado@its.jnj.com

Kristin Corrado, B.S

CONTACT

kcorrado@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Confidentiality of subject data will be maintained by both the site and the sponsor in accordance with the local regulations. Data protection consent will be obtained from subjects as part of the informed consent process or within a separate HIPAA document if required by local procedures. The data submitted to the sponsor will be pseudonymized, and subjects will not be identified by name or other identifiable information such as date of birth (DOB). Each subject will be assigned a specific subject identification number beginning with the site number and a consecutive subject number. The collection, use, and disclosure of all personal data, including subject health and medical information, are to be maintained in compliance with applicable personal data protection and security laws and regulations that govern protected health information and their informed consent given by each clinical study subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 10, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)