Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Altius Buechel-Pappas Primary Total Knee replacement System (Co-Cr Mobile Bearing Knee Cemented): Following up prospectively for a period of 15 years with the recruited subjects at
de
Sponsors
TTK Healthcare Ltd (Ortho Division)
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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) 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Revision rate, Risk monitoring and Adverse event monitoring during clinical and telephonic follow upTimepoint: 15 years | — |
Primary
| Measure | Time frame |
|---|---|
| Device performance will be analysed by parameters such as : a) Knee Scores (Knee society score and WOMAC scores) are collected to clinically analyse pain and activities of daily lives for each subject in the study population . b) Measurement of range of motion c) Radiographic analysisTimepoint: 15 years | — |
Countries
India
Contacts
Public ContactDr Aashish Chaudhry
Aakash Healthcare Super Speciality Hospital
Outcome results
None listed