NCT04128852撤回不适用
A Prospective, Single Arm, Single-center Study to Assess the Safety and Performance of MagnetOs Putty in Patients Undergoing Single/Two-level Lateral Lumbar Interbody Fusion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Radiographic interbody fusion by CT scan
研究概览
简要总结
This study is a post-marketing clinical follow-up study for MagnetOs Putty. MagnetOs Putty is a synthetic bone-like material which is routinely used by surgeons as a treatment for patients with degenerative disc disease who will undergo surgery for spinal fusion (extreme lateral interbody fusion (XLIF). MagnetOs Putty will be used according to the instructions for use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent by the patient.
- •Male or female patient ≥ 25 up to and including 75 years old.
- •Patients with degenerative disc disease with up to grade 1 spondylolisthesis and with leg pain requiring 1 to 3 level laminectomy and a single/two-level fusion (L2 - S1). Degenerative disc disease is defined by the presence of one or more of the following:
- •instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
- •osteophyte formation of facet joints or vertebral endplates,
- •decreased disc height by > 2 mm, but dependent upon the spinal level,
- •scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
- •disc degeneration and/or herniation,
- •facet degeneration,
- •vacuum phenomenon.
- •Patients with an Oswestry Disability Index (ODI) score ≥
- •Patients with a Visual Analogue Scale (VAS) leg score ≥
- •Failed conservative treatment (physical therapy, bed rest, medications, spinal injections or transcutaneous electrical nerve stimulation) for a period of 6 months prior to study enrollment.
排除标准
- •Per the current Instruction For Use, MagnetOs Putty must not be used in the following clinical situations:
- •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 stabilisation is not possible).
- •In case of significant vascular impairment proximal to the graft site.
- •In case of severe metabolic or systemic bone disorders 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.
- •In direct contact with the articular space.
- •In case of treatment with medication interfering with the calcium metabolism.
结局指标
主要结局
Radiographic interbody fusion by CT scan
时间窗: 12 months
The rate of interbody fusion assessed by CT-scan at Month 12. Radiographic fusion using CT-scan will be defined by an independent radiology expert at Month 12 post-surgery and determined by evidence of bridging trabeculae or continuous bony connection between superior and inferior vertebral body.
次要结局
未报告次要终点
研究者
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