CTRI/2024/10/074836招募中Unknown
A Prospective, Single Arm, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of Cervical System
Auxein Medical Private Limited2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月16日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. Radiological evaluation by X - rays to calculate meantime to achieve
研究概览
简要总结
This post marketing clinical follow up study is planned to evaluate the safety and performance of cervical plates and cages being manufactured by Auxein Medical Pvt Ltd. The Study plans to recruit a total of 60 patients from two centers. The total duration of study is two years including one year post-operative follow up of patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting to Orthopaedic OPD/emergency, requiring treatment with anterior cervical plate or/and cage.Specific indications include:
- •Single level tuberculosis
- •Cervical mylopathy
- •Single level degenerative disc disease.
排除标准
- •Patients with active local or systemic infection.
- •Patients with morbid obesity BMI more than 35 kg/m
- •Patients with mental disorders or currently on psychiatric treatment.
- •Alcoholics and or drug abusers.
- •Patients with metabolic bone disease.
- •Severe osteopenia
- •Metal sensitivity or allergies
- •Pregnant women or those planning pregnancy during study.
结局指标
主要结局
1. Radiological evaluation by X - rays to calculate meantime to achieve
时间窗: 6 week, 6 month, and 12 month
deformity correction/bone fusion.
时间窗: 6 week, 6 month, and 12 month
2. Follow-up of the patient’s recovery by analyzing Visual analogue
时间窗: 6 week, 6 month, and 12 month
scale (VAS) for pain assessment.
时间窗: 6 week, 6 month, and 12 month
次要结局
- 1. Improvement in quality of life through Neck disability index (NDI).(2. Evaluation of safety of device by record of any adverse event, serious)
研究者
Dr Mohd Aslam
Auxein Medical Private Limited
研究点 (2)
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