Degenerative Spine Disease
Conditions
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.
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.
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.
Demineralized Bone Matrix is to be used with bone marrow aspirate and mixed with autograft bone in accordance with approved indications per the IFU
Sponsors
DePuy Synthes Products, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | 12 Months | FIBERGRAFT Aeridyan Matrix percent levels fused at 12 months compared to the grafting control in the posterolateral lumbar spine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome | 12 Months | FIBERGRAFT Aeridyan Matrix clinical outcomes (NRS, ODI) change in baseline to 12 months compared to grafting control |
Countries
United States
Contacts
CONTACTStudy Contact
CONTACTKristin Corrado, B.S
STUDY_CHAIRKristin Corrado
DePuy Synthes Products, Inc.
Outcome results
None listed