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
DePuy Synthes Products, Inc.
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 tha…