Health Condition 1: M17- Osteoarthritis of knee
Conditions
Interventions
Intervention1: Altiusâ?¢ Buechel Pappas Primary Total Knee Replacement System (Co-Cr Mobile Bearing Knee- Cemented): â?¢ Subjects who were implanted with CE marked Altiusâ?¢ Buechel-Pappas Primary Tot
Sponsors
TTK Healthcare Ltd Ortho Division
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety by revision rate as endpoint, complications of the subjects. Performance by Subject Satisfaction rate: Changes in mean Knee Scores from discharge to each subsequent assessment and Pain and ADL assessment through various questionnairesTimepoint: 15 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse Events Reporting during prospective study period Where, adverse event is defined as the cumulative number of a severe knee related complication or unanticipated adverse device events (UADEs) over the 15 year period of postoperative observational years. 2. Subject Satisfaction rate: Changes in mean Knee Scores from discharge to each subsequent assessment, during prospective study period [Designated as safety issue: NO] Changes in mean Knee Society Score and/or Oxford Knee score from discharge to each subsequent assessment. 3. Radiographic Evaluation (Migration, Mal-alignment if any) maximum total point motion (MTPM) of 0.2 mm (SD 0.10) during prospective study period. 4. Pain and ADL assessment through various questionnaires (Current symptoms, onset symptoms, retro patellar tenderness Timepoint: 15 year | — |
Countries
India
Contacts
Public ContactDr AV Gurava Reddy
Head of department Sunshine hospital
Outcome results
None listed