NCT05631392进行中（未招募）不适用
A Prospective, Non-randomised, Multi-centre, Post-market Clinical Follow-up Observational Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Invibio Ltd
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Neck Disability Index (NDI) Questionnaire
研究概览
简要总结
Observational data collection of information after undergoing standard Cervical spine fusion surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 years of age or older (≥ 18 years) and are skeletally mature.
- •Subjects with discopathy, disc hernia with radiculopathy and/or myelopathy, or stenosis of the foramen and spinal canal with or without cervical radiculopathy/myelopathy, at one or two contiguous levels from C3 to C7, and confirmed by imaging studies (CT and/or MRI will be taken according to standard local procedures and confirmed by the Investigator that imaging represents the indication for surgery).
- •Subjects with a documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated.
- •Subjects who are indicated for surgical treatment with the BEE® HA Cage with RESORBA® Synthetic Bone injectable bone substitute (RESORBA Medical GmbH).
- •Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief.
排除标准
- •Subjects who have undergone previous spinal surgery either anterior or posterior.
- •Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
- •Subjects with a known allergy to the material used in the instrumentation.
- •Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
- •Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator.
- •Subjects who have any conditions outlined as contraindicated in the Instructions for Use.
结局指标
主要结局
Neck Disability Index (NDI) Questionnaire
时间窗: 24 months
Set of questions given to the subjects about experiencing pain during activities that are marked on a scale of 0-5 - whereby "0" is no pain and "5" is the worse pain. Maximum score for the questionnaire of "50" is possible.
次要结局
未报告次要终点
研究者
研究点 (2)
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