NCT06415123Enrolling By Invitation不适用
A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Compared to Cellular Allograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)
Research Source1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Posterolateral side fusion
研究概览
简要总结
The purpose of this study is to demonstrate the performance of MagnetOs Flex Matrix in patients with leg pain and/or back pain.
详细描述
This is a prospective, randomized, multi-center study that intends to demonstrate the performance of MagnetOs Flex Matrix compared to Cellular Allograft in patients with leg pain and/or back pain requiring up to four-level instrumented PLF surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is able to read/be read, understand, and provide written informed consent and has signed the 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 greater than 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.
- •Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.
- •Receiving treatment with medication interfering with calcium metabolism.
- •Has leg pain, and/or back pain related to benign or malignant tumor.
- •Has history or presence of active malignancy.
- •Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
- •Is involved in active litigation relating to his/her spinal condition.
- •Has participated in an investigational study within 30 days prior to surgery for study devices
结局指标
主要结局
Posterolateral side fusion
时间窗: 12 months post surgery
The percentage of the posterolateral sides with bridging bone for the MagnetOs Flex Matrix and control treatments using CT-scans and determined by evidence of bridging trabeculae or continuous bony connection between superior and inferior transverse processes.
次要结局
- Clinical outcome via neck visual analog scale (VAS)(12 months post-surgery)
- Posterolateral lumbar/thoraco-lumbar fusion(6 months post surgery)
- Clinical outcome via Oswestry Low Back Pain Disability Questionnaire (ODI)(12 months post-surgery)
- Secondary Surgical Interventions (SSI's)(12 months post-surgery)
研究者
研究点 (1)
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