Health Condition 1: null- Patient who need a primary Total Knee Arthroplasty and scheduled to receive the NexGen LPS-Flex Fixed Bearing Knee with the use of iASSIST Knee in the surgical procedure. Health Condition 2: M171- Unilateral primary osteoarthritisof knee
Conditions
Interventions
Intervention1: iASSIST Knee instrument for total knee arthroplasty: Instrument used during knee replacement surgery.
Control Intervention1: Conventional instrument for total knee arthroplasty: Instrum
Sponsors
Zimmer India Private Ld
Eligibility
Inclusion criteria
Inclusion criteria: Patient must meet the following criteria to be eligible for participation: 1. Over 18 years old. 2. Required to undergo primary TKA due to severe knee pain and disability from knee joint disease or condition (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, etc.) 3, Scheduled to receive NexGen LPS-Flex Fixed Bearing Knee or Persona PS Knee during the TKA. 4. Able to: -ï? Understand what participation in the study entails and give written informed consent. -ï? Follow surgeon/staff instructions. -ï? Return for all follow-up evaluations. 5 Willing to undergo the procedures specified in this protocol. 6. Participated in the Informed Consent process and has signed an EC/IRB approved Informed Consent form. 7. Meet an acceptable preoperative medical clearance and is free of cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.
Exclusion criteria
Exclusion criteria: Patient must not meet the following criteria to be eligible for participation: 1. In cases of hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, and chronic severe dislocation). 2. In cases of hip joint pathology or knee pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum, femoral condyle collapse). 3. Use of femoral anterior cut first surgical techniques. 4. Use of the Quad-Sparing• technique. 5. Scheduled for simultaneous bilateral TKA. 6. Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination. 7. Currently enrolled in another study. 8. Mental condition that may interfere with his/her ability to give an informed consent or interfere with his/her ability or willingness to fulfill the requirements of the study. 9. Active infection (including septic knee, distant infection, or osteomyelitis). 10. Severe hip arthrosis. 11. Neurological disorders (including, but not limited to Parkinsonâ??s disease). 12. Prior ipsilateral unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy. 13. Hip or knee ankylosis. 14. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin 15. Indications of intra- and/or extra-articular deformations that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, such as polio, history of tibial plateau fracture, etc. 16. A female who is pregnant or lactating. 17. Arterial disease or stents that would exclude the use of a tourniquet. 18. Insufficient quality or quantity of bone to support the implant due to prior knee surgery (or surgeries), cancer, metabolic bone disease, osteoporosis / osteopenia (diagnosed or treated with medication), active / old / remote infection, etc. 19. Condition that would place excessive demands on the implant (e.g.,Charcotâ??s joints, muscle deficiencies, multiple joint disabilities, skeletal immaturity, etc.). 20. Collateral ligament insufficiency. 21. Immunosuppressive disorder (e.g., AIDS,etc.) that would require cytotoxic drugs, corticosteroids, large dose of irradiation, or antilymphocytic serum. 22. An existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of alignment of the knee components based on the deviation from predefined angles measured with either CT scan or full-leg weight-bearing x-rayTimepoint: Postoperative 6-week follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ OR time â?¢ OR setup time â?¢ Blood loss â?¢ Number of instrument trays usedTimepoint: Intraoperative;ComplicationsTimepoint: Intraoperative and postoperative follow-ups at 6-week, 6-month, 1- and 2-year.;Functional and quality of life parametersTimepoint: Postoperative follow-ups at 6-week, 6-month, 1- and 2-year. | — |
Countries
Australia, India, Singapore, Thailand
Contacts
Public ContactGunjan Verma
Deenanath Mangeshkar Hospital
Outcome results
None listed