NCT05299762招募中不适用
A Post Market Surveillance on INFUSE Bone Graft
Medtronic Spinal and Biologics1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年8月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Fusion status at last assessment by 12 months post-surgery
研究概览
简要总结
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
详细描述
This study is a prospective, observational, multi-center, post-market surveillance to collect patient data regarding on-label use of INFUSE™ Bone Graft for lumbar fusion via ALIF or OLIF. Commercially available device will be used within its intended use.
This study is supposed to be conducted during a period of 4 years with 600 or more cases after the product approval in Korea. According to the standard of care in Korea, the patients will be followed at least 12 months post-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
- 否
入选标准
- •Has degenerative disc disease and is indicated for lumbar interbody spine fusion from L2-S1 with INFUSE™ Bone Graft via ALIF or OLIF technique
- •Agrees to participate in the study and is able to understand and sign the Informed Consent
- •The procedure planned for the patient complies with the labeling of the devices that may be used in the surgical procedure
- •Has at least six months of nonoperative treatment prior to the study treatment
- •Is at least 18 years old at the time of informed consent
排除标准
- •Has a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation
- •Has any active malignancy or undergoes treatment for a malignancy, or operative site is in the vicinity of a resected or extant tumor
- •Is skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure)
- •Is pregnant or lactating
- •Has an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone
- •The use of the Infuse™ Bone Graft component implanted at locations other than the lower lumbar spine (e.g., cervical spine)
- •Repeat applications of the Infuse™ Bone Graft component
- •Has up to Grade 1 retrolisthesis
- •Has hepatic or renal impairment
- •Has metabolic bone disease
- •Has autoimmune disease
- •Has immunosuppressive disease or suppressed immune systems resulting from radiation therapy, chemotherapy, steroid therapy, or other treatments
- •Is illiterate or vulnerable (e.g., the participant is incapable of judgment or is under tutelage) as per the investigator's assessment
- •Concurrent participation in another clinical study that may confound study results
- •Has a considerable risk for surgery
- •Has a condition that could compromise study (e.g., mentally incompetent, alcohol or drug abuse) as per the investigator's assessment
结局指标
主要结局
Fusion status at last assessment by 12 months post-surgery
时间窗: Surgery to 12 months
Radiographic assessment of interbody fusion will be conducted using x-rays and/or CTs
Adverse device effects by 12 months post-surgery
时间窗: Surgery to 12 months
Summarize adverse device effects
次要结局
- Adverse events of interest up to 12 months post-surgery(Surgery to 12 months)
- Rate of neurological success at 6 weeks, 3, 6, 12 months post-surgery(Baseline (pre-op) to 12 months)
- Clinical outcome (ODI) at 6 weeks, 3, 6, 12 months post-surgery(Baseline (pre-op) to 12 months)
- Clinical outcome (VAS) at 6 weeks, 3, 6, 12 months post-surgery(Baseline (pre-op) to 12 months)
研究者
研究点 (1)
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