Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

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.

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

Details

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.

Keywords

Degenerative Spine Disease, FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute, Demineralized Bone Matrix

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • UC Davis Health System
    Sacramento 5389489 California 5332921 95816 United States
  • UT Health Houston
    Houston 4699066 Texas 4736286 77030 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
DePuy Synthes Products, Inc.
ID
NCT07059065
Study Type
Interventional
Participants
Expecting 316 study participants
Last Updated