CTRI/2026/04/108646尚未招募不适用
A Multicenter, Prospective, Observational study to Evaluate the Performance and Safety of the ACTIKNEE Knee Implant in Adult Patients Undergoing Total knee arthroplasty (TKA) Surgery.
ALKEM MEDTECH ORTHO PRIVATE LIMITED1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2026年4月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
研究概览
简要总结
This is a prospective Observational multicenter post marketing surveillance study. Adult patients with a diagnosis of symptomatic knee osteoarthritis requiring total knee arthroplasty who are eligible to undergo TKA using the ACTIKNEE knee implant in conjunction with high quality bone cement as per standard surgical practice will be screened based on the study inclusion and exclusion criteria.
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
- •Adult participants aged 18 to 75 years, of any gender.
- •Participants with a confirmed diagnosis of symptomatic knee osteoarthritis requiring total knee arthroplasty (TKA).
- •Participants who are eligible to undergo TKA using the ACTIKNEE knee implant in conjunction with high-quality bone cement, as determined at the investigator discretion and in accordance with standard surgical practice.
- •Written informed consent obtained from each participant prior to study enrollment.
- •Willing and able to comply with all study procedures, protocol requirements, and scheduled follow-up visits.
排除标准
- •Patients with a history of prior knee arthroplasty or revision surgery in the target knee.
- •Patients with an active knee joint infection or a history of infection in the target knee within the past 12 months.
- •Patients with severe bone loss, bone deformity, or other structural abnormalities that would preclude proper implant placement, as determined by the investigator.
- •Patients with a history of systemic infection, immunodeficiency, or any other illness that significantly limits mobility or could interfere with postoperative recovery.
- •Patients with a known allergy or hypersensitivity to any component of the ACTIKNEE knee implant or bone cement.
- •Patients with significant uncontrolled comorbidities (e.g., poorly controlled diabetes mellitus, unstable cardiovascular disease, or other severe systemic illness) that, in the opinion of the investigator, could adversely affect surgical outcomes or compliance with follow-up.
- •Any patient who, in the opinion of the investigator, is not considered suitable for the study due to medical, psychological, or social reasons that may compromise safety, compliance, or study outcomes.
研究者
Dr Arnab Karmakar
Consultant Orthopedic Surgeon
研究点 (1)
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