A single centric, open-label, observational, retrospective and prospective, Post-Market Clinical Follow-up study of Altiusâ?¢ Buechel Pappas Primary Total Knee Replacement System (Co-Cr Mobile Bearing Knee- Cemented)

TTK Healthcare Ltd Ortho Division0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年4月4日

试验速览

阶段: 4 期
状态: 尚未招募
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Pms

入排标准

入选标准

•1. Male or female subjects who were implanted with CE marked AltiusTM BuechelPappas High Flex Total Knee Replacement System (Co-Cr Mobile Bearing Knee- Cemented) 2. 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) 3. Subject agrees to provide approved written informed consent to and to follow the study visit schedule (as defined in the study protocol and informed consent document) 4. Subjects whose routine radiographic assessment is possible 5. Subject is of minimum 18 years and a maximum of 75 years of age, at the time of surgery 6. Subjects falling under at least one of below mentioned category of intended indicated use of the Implant such as : a. Someone who is skeletally mature b. Someone who has not responded to non-operative treatment (i.e. Drug or physical therapy) for a period of 6 months
•c. Someone who has stable and intact ligaments for medial and lateral collateral d. Someone with intact quadriceps and hamstring mechanisms e. Someone with a poor knee score indication f. Someone whose primary surgery occurs when there is a suitable bone stock (complete cortical contact with the tibial and femoral component edges) which in turn enables sufficient seating of the components

排除标准

•Subjects who underwent TKA without CE marked Altius• (Co-Cr Mobile Bearing Knee- Cemented)
•Subjects who underwent TKA having contraindications mentioned in IFU.
•Subject has severe pronation of the ipsilateral foot or any other relevant clinical condition
•contributing to abnormal ambulation (including but not limited to ankle fusion, ankle arthroplasty, previous hip fracture, ipsilateral hip arthritis resulting in flexion contracture)
•Subject has undergone a previous major surgery to the study knee (including osteotomy, fracture fix, medial or lateral ligament surgery)
•Subject has active infection or sepsis (treated or untreated)
•At the time of enrolment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the Investigator:
•a Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
•b Contralateral primary total knee or Unicondylar (Partial) knee arthroplasty
•Subject weight over 150 kilograms
•Subject requires revision TKA
•Metabolic disorders which may impair bone formation or re-growth
•Subject has any other medical condition that may overlap with the isolation of the desired parameter monitoring, as required by this study
•Subjects with uncontrolled diabetes mellitus/ hypertension
•Subject is expected to require bilateral TKA within 1 year following study knee replacement
•Subject does not understand the language used in the Informed Consent Form
•Subject is enrolled in another clinical study at the same time
•Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
•Subject has inadequate bone stock to support the device (severe osteopenia, family history of severe osteoporosis or osteopenia or osetomalacia) or lower extremity orthopaedic problems that limits function
•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 presence of malignant tumour (Active malignancy), metastatic, or neoplastic disease

研究者

发起方

TTK Healthcare Ltd Ortho Division

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