FIBERGRAFT Aeridyan Posterolateral Fusion Study

ConditionDegenerative Spine Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorDePuy Synthes Products, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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

Treatment groups

316 Participants

are divided into 4 treatment groups

Group A: Cohort A)Experimental treatment 1 intervention

Group B: Cohort BExperimental treatment 1 intervention

Group C: Controlled Cohort AActive comparator 1 intervention

Group D: Controlled Cohort BActive comparator 1 intervention

Trial outcomes

Primary outcomes

Primary outcome

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

Time frame

12 Months

Secondary outcomes

Secondary Outcome

FIBERGRAFT Aeridyan Matrix clinical outcomes (NRS, ODI) change in baseline to 12 months compared to grafting control

Time frame

12 Months

Secondary Outcome

FIBERGRAFT Aeridyan Matrix clinical outcomes (NRS, ODI) change in baseline to 24 months compared to grafting control

Time frame

24 months

Secondary Outcome

FIBERGRAFT Aeridyan Matrix percent levels fused at 6 months compared to the grafting control in the posterolateral lumbar spine

Time frame

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

Time frame

6 months and 12 months

Other outcomes

Exploratory Endpoint

FIBERGRAFT Aeridyan Matrix percent levels fused at 6 months compared to the grafting control in Cohort B in the posterolateral lumbar spine

Time frame

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

Time frame

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

Time frame

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

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DePuy Synthes Products, Inc.

Lead sponsor

Source ClinicalTrials.gov

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