FIBERGRAFT Aeridyan Posterolateral Fusion Study

Purpose

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.

Condition

  • Degenerative Spine Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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. 2. Skeletally mature subjects at least 18 years of age at the time of consenting. 3. Willing to provide voluntary written informed consent prior to participation in the clinical study.

Exclusion Criteria

  1. Subjects who had previous fusion surgery at the index level(s). 2. Requiring a Posterolateral Fusion in the lumbar spine at more than three levels and/or an interbody fusion at more than two levels 3. Subjects who have demonstrated allergy or foreign body sensitivity to the implant or graft material. 4. Pregnant subjects or planning to become pregnant within the next 24 months. 5. Subjects diagnosed with severe osteoporosis which may prevent adequate fixation and thus preclude the use of these or any other orthopedic implant. 6. Subjects diagnosed with severe instabilities, vertebral fractures, spinal tumors. 7. 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. 8. Subjects requiring use of an implantable bone graft stimulator or external bone graft stimulator. 9. 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. 10. Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator. 11. Dependency on pharmaceutical drugs, drug abuse, or alcoholism resulting in a lack of subject cooperation. 12. Subjects unable to comply, and/or in the Investigator's opinion unable to comply, with the requirements of participation in the clinical study. 13. Enhanced Demineralized Bone Matrix product for the grafting control used within the posterolateral spine 14. Use of Bone Morphogenetic Protein (BMP) grafting material within the interbody cage(s). 15. Body Mass Index (BMI) ≥ 45 16. Unilateral posterior instrumentation 17. Subject is currently involved in a workers' compensation claim. 18. Subject has participated in an interventional clinical trial within the last 6 months or plans to participate in an interventional clinical trial within the next 24 months.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Device: FIBERGRAFT™ 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.
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
  • Device: FIBERGRAFT™ 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.
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
  • Device: Demineralized 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
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
  • Device: Demineralized 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

Recruiting Locations

University Of Illinois
Chicago 4887398, Illinois 4896861 60612

UK Health Care Kentucky Neuroscience Institute
Lexington 4297983, Kentucky 6254925 40536

More Details

Status
Recruiting
Sponsor
DePuy Synthes Products, Inc.

Study Contact

Study Contact
857-488-0221
kcorrado@its.jnj.com

Detailed Description

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.