FIBERGRAFT Aeridyan Posterolateral Fusion Study
a study on Degenerative Spine Disease
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis
- Dates
- study startedstudy 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
- 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.
You CAN'T join if...
- 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.
- 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.
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