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| ID | Type | Description | Link |
|---|---|---|---|
| DSS202303 | Other Identifier | DePuy Synthes Products, Inc. |
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This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFTâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIBERGRAFTâ„¢ Aeridyan Matrix Bone Graft Substitute | Device | FIBERGRAFTâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome | FIBERGRAFT Aeridyan Matrix percent levels fused at 12 months compared to the grafting control in the posterolateral lumbar spine | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome | FIBERGRAFT Aeridyan Matrix clinical outcomes (NRS, ODI) change in baseline to 12 months compared to grafting control | 12 Months |
| Secondary Outcome | FIBERGRAFT Aeridyan Matrix clinical outcomes (NRS, ODI) change in baseline to 24 months compared to grafting control |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint | FIBERGRAFT Aeridyan Matrix percent levels fused at 6 months compared to the grafting control in Cohort B in the posterolateral lumbar spine | 6 months |
| Exploratory Endpoint | FIBERGRAFT Aeridyan Matrix percent levels fused at 12 months compared to the grafting control in Cohort B in the posterolateral lumbar spine |
INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 857-488-0221 | kcorrado@its.jnj.com | |
| Kristin Corrado, B.S | Contact | kcorrado@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Kristin Corrado | DePuy Synthes Products, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Health System | Recruiting | Sacramento | California | 95816 | United States | |
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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.
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| 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 |
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| 24 months |
| Secondary Outcome | FIBERGRAFT Aeridyan Matrix percent levels fused at 6 months compared to the grafting control in the posterolateral lumbar spine | 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 | 6 months and 12 months |
| Secondary Outcome | Reoperation/Revision rates of FIBERGRAFT Aeridyan Matrix compared to the grafting control | Through study completion |
| 12 Months |
| Exploratory Endpoint | FIBERGRAFT Aeridyan Matrix percent subjects fused at 6 months compared to the grafting control in Cohort B in the posterolateral lumbar spine | 6 months |
| Exploratory Endpoint | FIBERGRAFT Aeridyan Matrix percent subjects fused at 12 months compared to the grafting control in Cohort B in the posterolateral lumbar spine | 12 months |
| University Of Illinois |
| Recruiting |
| Chicago |
| Illinois |
| 60612 |
| United States |
| University of Kentucky Medical Center | Recruiting | Lexington | Kentucky | 40536 | United States |
| Brigham And Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic Rochester | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
| Duke University Medical Center | Not yet recruiting | Durham | North Carolina | 27710 | United States |
| Rothman Orthopaedics Institute | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| UT Health Houston | Not yet recruiting | Houston | Texas | 77030 | United States |