RecruitingNot Applicable

FIBERGRAFT Aeridyan Posterolateral Fusion Study

United States316 participantsStarted 2025-08-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Primary outcome

Timeframe: 12 Months

Trial details

NCT IDNCT07059065

SponsorDePuy Synthes Products, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-05-31

Contact for this trial

Study Contact

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

View on ClinicalTrials.gov More Degenerative Spine Disease trials