DRKS00030844招募中不适用
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 - BEE HA CAGE
Invibio Biomaterial Solutions0 个研究点目标入组 51 人开始时间: 2022年12月13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
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1.Subjects aged 18 years of age or older (> 18 years) and are skeletally mature.
- •2.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).
- •3.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.
- •4.Subjects who are indicated for surgical treatment with the BEE® HA Cage with In’Oss injectable bone substitute (Biomatlante Biologics Solutions).
- •5.Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief.
- •6.Female subjects of childbearing age must have a negative pregnancy test, or must have a history of a surgical sterilisation, or must give history of no menses in the past twelve months.
- •7.Subjects who, in the opinion of the Investigator, are able to understand the nature, aims and possible consequences of the clinical study, co-operate with the procedures, and are willing to return to the clinic for all required post-operative follow-ups.
- •8.Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.
排除标准
- •1.Subjects who have undergone previous spinal surgery either anterior or posterior.
- •2.Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
- •3.Subjects with a known allergy to the material used in the instrumentation.
- •4.Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
- •5.Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator.
- •6.Subjects who have any conditions outlined as contraindicated in the Instructions for Use.
- •7.Subjects who are receiving any drug treatment that may affect bone metabolism.
- •8.Female subjects who are pregnant or lactating.
- •9.Subjects who are known drug or alcohol abusers, or with a baseline opioid use greater than 30 mg of morphine equivalent/day, or with psychological disorders that could affect follow-up care or treatment outcomes.
- •10.Subjects who are currently enrolled in a clinical study.
- •11.Subjects who are currently involved in any injury litigation claims.
- •12.Subjects who are kept in an institution under judicial or official orders or in a residential care institution or performing mandatory military service.
研究者
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