FIBERGRAFT Aeridyan Posterolateral Fusion Study

DePuy Synthes

Status: Enrolling

Conditions: Degenerative Spine Disease

Treatments: Device: Demineralized Bone Matrix; Device: FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute

Study type: Interventional

Funder types: Industry

Identifiers

NCT07059065

DSS202303 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 316 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

316 participants in 4 patient groups

Cohort A)

Experimental group

Description:

Arm 1: 79 subjects (Cohort A) treated with FIBERGRAFT Aeridyan Matrix bone graft substitute in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1. Cohort A will have a score range of 6 - 14.5

Treatment:

Device: FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute

Cohort B

Experimental group

Description:

Arm 2: 79 subjects (Cohort B) treated with FIBERGRAFT Aeridyan Matrix bone graft substitute in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1. Cohort B will have a score range of 14.6 - 43.5

Treatment:

Device: FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute

Controlled Cohort A

Active Comparator group

Description:

Arm 3: 79 subjects (Cohort A) treated with Demineralized Bone Matrix in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1. Cohort A will have a score range of 6 - 14.5

Treatment:

Device: Demineralized Bone Matrix

Controlled Cohort B

Active Comparator group

Description:

Arm 4: 79 subjects (Cohort B) treated with Demineralized Bone Matrix in a 1 to 3 level instrumented lumbar posterolateral fusion including up to 2 consecutive levels of a posterior lumbar interbody fusion between L1-S1. Cohort B will have a score range of 14.6 - 43.5

Treatment:

Device: Demineralized Bone Matrix