Health Condition 1: M255- Pain in joint
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. All primary Osteoarthritis (OA) knee, Rheumatoid arthritis (RA) knee / Post-Traumatic Osteoarthritis undergoing Single implant â?? Stryker triathlon using MAKO Robotic system 2. Male and females aged 21 years to 85 years (inclusive) 3. Subject is willing to take part in the study by signing Ethics Committee (EC) approved informed consent form (ICF) 4. Subject agrees to comply with postoperative scheduled clinical and radiographic evaluation
Exclusion criteria
Exclusion criteria: 1. Revision TKA 2. Using constraint knee 3. Knee with tumours, infection 4. Patients shall be excluded from the study if their data is not captured by the computer software 5. Patient with a neuromuscular or neurosensory deficiency that may affect the ability to evaluate the study endpoints. 6. Patients who are known drug or alcohol abusers or with psychological disorders that could affect follow up care or treatment outcomes. 7. Patients with a history of deep vein thrombosis or other thrombotic disorders. 8. Clinical signs of a coexisting severe acute systemic illness (Pneumonia, sepsis, UTI, other co-morbidities) 9. Diagnosis of immune deficiency (AIDS, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc.) 10. Patient is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study. 11. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i) To evaluate the accuracy of bone resection by the MAKO software. ii) To measure the tibial component rotation. iii) To evaluate the functional outcome at the end of 2 years using patient-reported outcomes and correlate with the accuracy of bone resections and tibial component rotation. Timepoint: Screening. Post-op Day 1, Week 6, Month 3 and year 1 and 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: Not Applicable | — |
Countries
India
Contacts
Anup Institute of Orthopedics and Rehabilitation