Clariance Registry of ERISMA® and Idys® Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Clariance
- 入组人数
- 760
- 试验地点
- 1
- 主要终点
- Revision rate
研究概览
简要总结
International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF).
The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting.
The primary objective is to demonstrate that the use of the study devices is safe.
The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.
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
- •Considered as adult in the respective geography (18 years old or older for France and 21 years old or older for United-States).
- •Indicated for treatment with one or more commercially available sponsor spine device included into the study.
- •For France only, affiliated with or beneficiary of a social security scheme.
排除标准
- •Subjects who are not able to comply with the study procedures based on the judgment of the investigator (e.g., inability to comprehend study related questions, inability to keep scheduled assessment times).
- •Subjects who are considered as vulnerable: minor, pregnant woman or people under legal protection (guardianship or curatorship).
- •Contraindicated for spine surgery utilizing a commercially available sponsor spine device.
研究组 & 干预措施
Idys® ALIF 3DTi
50 subjects with Idys® ALIF 3DTi implant
干预措施: Spine surgery (Procedure)
Idys® ALIF TiVAC
50 subjects with Idys® ALIF TiVAC implant
干预措施: Spine surgery (Procedure)
Idys® ALIF ZP 3DTi
50 subjects with Idys® ALIF ZP 3DTi implant
干预措施: Spine surgery (Procedure)
Idys® LLIF 3DTi
50 subjects with Idys® LLIF 3DTi implant
干预措施: Spine surgery (Procedure)
Idys® ALIF PEEK
50 subjects with Idys® ALIF PEEK implant
干预措施: Spine surgery (Procedure)
ERISMA® LP/LP EVO
120 subjects with ERISMA® LP/LP EVO implant
干预措施: Spine surgery (Procedure)
ERISMA® Deformity
120 subjects with ERISMA® Deformity implant
干预措施: Spine surgery (Procedure)
ERISMA® MIS
120 subjects with ERISMA® MIS implant
干预措施: Spine surgery (Procedure)
Idys® TLIF PEEK
50 subjects with Idys® TLIF PEEK implant
干预措施: Spine surgery (Procedure)
Idys® TLIF TiVAC
50 subjects with Idys® TLIF TiVAC implant
干预措施: Spine surgery (Procedure)
Idys® TLIF 3DTi
50 subjects with Idys® TLIF 3DTi implant
干预措施: Spine surgery (Procedure)
结局指标
主要结局
Revision rate
时间窗: Year 2
Revision (each time a primary study implant is removed during an additional necessary surgery) rates, as a percentage of the total of cases per primary study device.
次要结局
- Oswestry Disability Index (ODI)(Pre-op; Week 9; Month 6; Year 1; Year 2)
- Back & Leg Pain Visual Analog Score (VAS)(Pre-op; Week 9; Month 6; Year 1; Year 2)
- Subject's Satisfaction(Week 9; Month 6; Year 1; Year 2)
- Radiological parameter: bony fusion(Week 9; Month 6; Year 1; Year 2)
- Adverse Events(Through study completion, an average of 2 years)
- Device Deficiencies(Through study completion, an average of 2 years)
- Self-report multipurpose short-form (SF-12v2®)(Pre-op; Week 9; Month 6; Year 1; Year 2)