Degenerative Spine DiseaseNCT07059065
FIBERGRAFT Aeridyan Posterolateral Fusion Study
A study testing FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute and Demineralized Bone Matrix in people with Degenerative Spine Disease, run by DePuy Synthes Products, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Spine Disease
- What is being tested?
- FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute and Demineralized Bone Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Aug 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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
- Unilateral posterior instrumentation
- Subject is currently involved in a workers' compensation claim.
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kristin Corrado, B.S contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Brigham And Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
University Of Illinois
Chicago, Illinois, 60612
- Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, 40536
- Recruiting
Rothman Orthopaedics Institute
Philadelphia, Pennsylvania, 19107
- Recruiting
UC Davis Health System
Sacramento, California, 95816
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Degenerative Spine Disease
- Being tested
- FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute, Demineralized Bone Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIBERGRAFT™ Aeridyan Matrix Bone Graft SubstituteDevice
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 MatrixDevice
Demineralized Bone Matrix is to be used with bone marrow aspirate and mixed with autograft bone in accordance with approved indications per the IFU
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Device: Demineralized Bone Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
FIBERGRAFT Aeridyan Matrix percent levels fused at 12 months compared to the grafting control in the posterolateral lumbar spine
Measured: 12 Months
Secondary outcomes (5)
Secondary Outcome
FIBERGRAFT Aeridyan Matrix clinical outcomes (NRS, ODI) change in baseline to 12 months compared to grafting control
Measured: 12 Months
Secondary Outcome
FIBERGRAFT Aeridyan Matrix clinical outcomes (NRS, ODI) change in baseline to 24 months compared to grafting control
Measured: 24 months
Secondary Outcome
FIBERGRAFT Aeridyan Matrix percent levels fused at 6 months compared to the grafting control in the posterolateral lumbar spine
Measured: 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
Measured: 6 months and 12 months
Secondary Outcome
Reoperation/Revision rates of FIBERGRAFT Aeridyan Matrix compared to the grafting control
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start15 Aug 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Spine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DePuy Synthes Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Corrado, Study chair, DePuy Synthes Products, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059065
- Sponsor's protocol ID
- DSS202303
- Other IDs
- DSS202303
- Status last verified
- Nov 2026
- First submitted
- 19 Jun 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07059065
- Acronym / sponsor ID
- DSS202303
- Conditions
- Degenerative Spine Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- DePuy Synthes Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A) | Experimental | Device: FIBERGRAFT™ Aeridyan Matrix Bone Graft SubstituteArm 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 |
| Cohort B | Experimental | Device: FIBERGRAFT™ Aeridyan Matrix Bone Graft SubstituteArm 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 |
| Controlled Cohort A | Active comparator | Device: Demineralized Bone MatrixArm 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 |
| Controlled Cohort B | Active comparator | Device: Demineralized Bone MatrixArm 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIBERGRAFT™ Aeridyan Matrix Bone Graft SubstituteFIBERGRAFT™ 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. | Device | Cohort A), Cohort B |
| Demineralized Bone MatrixDemineralized Bone Matrix is to be used with bone marrow aspirate and mixed with autograft bone in accordance with approved indications per the IFU | Device | Controlled Cohort A, Controlled Cohort B |
Primary outcome
Primary outcome
Time frame: 12 Months
FIBERGRAFT Aeridyan Matrix percent levels fused at 12 months compared to the grafting control in the posterolateral lumbar spine
5 secondary outcomes
Secondary Outcome
Time frame: 12 Months
Secondary Outcome
Time frame: 24 months
Secondary Outcome
Time frame: 6 months
Secondary Outcome
Time frame: 6 months and 12 months
Secondary Outcome
Time frame: Through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Corrado, B.S contact
Kristin Corrado study chair
DePuy Synthes Products, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute and Demineralized Bone Matrix in people with Degenerative Spine Disease, run by DePuy Synthes Products, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (857-488-0221, kcorrado@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.