A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Mixed With Local Autograft Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)
概览
- 阶段
- 不适用
- 干预措施
- MagnetOs Flex Matrix
- 疾病 / 适应症
- 未指定
- 发起方
- Kuros Biosurgery AG
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Radiographic Fusion by CT Scan
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery.
In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.
Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.
详细描述
In this study, following a screening period of a maximum of 30 days, 100 patients will undergo up to four-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Flex Matrix on the assigned side of the spine and Trinity Elite on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12. The primary endpoint will be analyzed at Month 12. In this study, MagnetOs Flex Matrix will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Flex Matrix will be used as a bone graft extender mixed with autograft in a 1:1 vol% in patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion. Radiographs will be obtained at Screening, Week 2, Week 6, Month 3, Month 6 and Month 12. CT-scans will only be obtained at Month 6 and Month 12.
研究者
入排标准
入选标准
- •Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.
- •Male or female patient ≥ 18 years old.
- •Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1)
- •Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment.
排除标准
- •Requires \> four-level fusion or expected to need secondary intervention within one year following surgery.
- •Had prior PLF fusion or attempted PLF fusion at the involved levels
- •Had previous decompression at the involved levels.
- •Women who are or intend to become pregnant within the next 12 months
- •To treat conditions in which general bone grafting is not advisable.
- •In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible).
- •In case of significant vascular impairment proximal to the graft site.
- •In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.
- •In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
- •When intraoperative soft tissue coverage is not planned or possible.
研究组 & 干预措施
MagnetOs Flex Matrix
MagnetOs Flex Matrix use in instrumented posterolateral fusion, 5cc-10cc mixed with local autograft bone in a 1:1 ratio per spine level at the randomized assigned side
干预措施: MagnetOs Flex Matrix
Trinity Elite
Trinity Elite is a cryopreserved, viable cellular allograft containing cancellous bone and demineralized cortical bone designed for surgical use, applied per spine level at the contralateral side. Trinity Elite will be used as a bone graft extender (mixed with local autograft)
干预措施: Trinity Elite
结局指标
主要结局
Radiographic Fusion by CT Scan
时间窗: Month 12
The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
次要结局
- Radiographic Fusion by Plain Radiographs(Month 6 and Month 12)
- Radiographic Fusion by CT Scan(Month 6)
- Functional Outcome by Oswestry Disability Index(Screening, Week 2, Week 6, Month 3, Month 6, Month 12)
- Back and Leg Pain by Visual Analog Pain Scale (VAS)(Screening, Week 2, Week 6, Month 3, Month 6, and Month 12)
- Neurologic Status by Physical Exam(Screening, Week 2, Week 6, Month 3, Month 6, and Month 12)
- Success Rate(Week 2, Week 6, Month 3, Month 6, and Month12)