CTRI/2025/04/085046尚未招募Unknown
An open-label, prospective, single centric, non-comparative, observational, Post-Market Clinical Follow-up to evaluate the safety and effectiveness of AltiusTM Buechel Pappas High Flex Total Knee Replacement System in Adult subject for a period of 15 years
TTK Healthcare Ltd (Ortho Division)1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年7月3日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Device performance will be analysed by parameters such as :
研究概览
简要总结
The purpose of the study is to confirm the safety and performance of the device throughout its expected lifetime based on state-of-the-art; identify previously unknown complications and monitor the residual risks and contraindications; identify and analyze emergent risks on the basis of factual evidence; and ensure the continued acceptability of the benefit-risk ratio. The prospective follow-up period with the recruited subjects is 15 years at defined time intervals.
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
- •Male or female subjects who were implanted with CE marked AltiusTM Buechel Pappas High Flex Total Knee Replacement System (Co-Cr Mobile Bearing Knee- Cemented)
- •Subjects that underwent TKR due to degenerative joint disease (primary Osteo Arthritis, post- traumatic arthritis, avascular necrosis (Osteochondritis), Rheumatoid Arthritis, abnormal formation or alignment of the knee).
排除标准
- •Subjects who underwent TKA without CE marked Altius (Co-Cr MobileBearing Knee- Cemented) Subjects who underwent TKA having contraindications mentioned in IFU.
- •Subject has clinical conditions contributing to abnormal ambulation Subject has undergone a previous major surgery to the study knee Subject has active infection or sepsis (treated or untreated), not caused due to Buechel Pappas Total Knee replacement system Subject has presence of malignant tumor such as Active lamignancy, metastatic, or neoplastic disease Subject has conditions that may interfere with the TKA survival or outcome such as Paget’s bone disease, Charcot’s joint’s neuroarthropathy disease, muscular atrophy, metabolic disorders that affect bone regrowth, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease Subject has any acute or chronic morbidity of vascular origin that, in the opinion of the Medical Investigator, is likely to compromise successful treatment or compliance to follow up visits Subject has inadequate bone stock to support the device such as severe osteopenia, family history of severe osteoporosis or osteopenia or osteomalacia or lower extremity orthopaedic problems that limits function Subject has an emotional or neurological condition that would preempt their ability or willingness to participate in the study Subject BMI greater than 40 Pregnant Women Subject is enrolled in another clinical study at the same time.
结局指标
主要结局
Device performance will be analysed by parameters such as :
时间窗: 15 years
a) Knee Scores (Knee society score and WOMAC scores) are collected to
时间窗: 15 years
clinically analyse pain and activities of daily lives for each subject in the study
时间窗: 15 years
population .
时间窗: 15 years
b) Measurement of range of motion
时间窗: 15 years
c) Radiographic analysis
时间窗: 15 years
次要结局
- Revision rate, Risk monitoring and Adverse event monitoring during clinical and telephonic follow up(15 years)
研究者
Dr Aashish Chaudhry
Aakash Healthcare Super Speciality Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
3 期
A Phase 3 Ayurvedic clinical study to assess the safety and benefits of using Boswellia Curcumin and Joint Aid Plus together in people having joint pain.CTRI/2025/10/096204Planet Ayurveda Private Limited60
尚未招募
不适用
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in AdultsHearing LossNCT07338864Cochlear66
招募中
1 期
An early Phase 1b Study to assess how safe and effective is the treatment with drugs, called Mosunetuzumab or Glofitamab in Combination with drugs called, CC-220 and CC-99282 in Patients with B-Cell Non-Hodgkin Lymphoma.2023-505185-28-00F. Hoffmann-La Roche AG52
招募中
不适用
Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG)NCT07413835The Affiliated Hospital of Xuzhou Medical University6
招募中
1 期
A Phase I trial to establish the safety and maximum tolerated dose of high-affinity autologous BCMA-targeting CAR-T cells in patients with relapsed and refractory B-cell malignancies (CARLOTTA01)2022-502831-20-00Technische Universitat Dresden16