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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 316
- 试验地点
- 5
- 主要终点
- Primary outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Confidentiality of subject data will be maintained by both the site and the sponsor in accordance with the local regulations. Data protection consent will be obtained from subjects as part of the informed consent process or within a separate HIPAA document if required by local procedures. The data submitted to the sponsor will be pseudonymized, and subjects will not be identified by name or other identifiable information such as date of birth (DOB). Each subject will be assigned a specific subject identification number beginning with the site number and a consecutive subject number. The collection, use, and disclosure of all personal data, including subject health and medical information, are to be maintained in compliance with applicable personal data protection and security laws and regulations that govern protected health information and their informed consent given by each clinical study subject.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-S
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort B
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
干预措施: FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute (Device)
Controlled Cohort A
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
干预措施: Demineralized Bone Matrix (Device)
Controlled Cohort B
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
干预措施: Demineralized Bone Matrix (Device)
Cohort A)
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
干预措施: FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute (Device)
结局指标
主要结局
Primary outcome
时间窗: 12 Months
FIBERGRAFT Aeridyan Matrix percent levels fused at 12 months compared to the grafting control in the posterolateral lumbar spine
次要结局
- Secondary Outcome(12 Months)
- Secondary Outcome(24 months)
- Secondary Outcome(6 months)
- Secondary Outcome(6 months and 12 months)
- Secondary Outcome(Through study completion)