Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants aged above 18 years, irrespective of gender, scheduled to undergo implantation of a Total Knee System using Medial Congruent and Ultra Congruent liners. 2. Participants with a primary diagnosis of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. 3. Participants with functional deformities, post-traumatic loss of knee joint contour with patellofemoral erosion, dysfunction, or prior patellectomy, and for moderate valgus,varus, or flexion trauma. 4.Participants with knee fractures that are untreatable by other methods. 5. Participants willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved informed consent form to participate in this post-market clinical follow-up study. 6. The participants should be able to comply with protocol requirements and assessments. 7. Participants must refrain from participating in any other trial or invasive study for a period of 6 months.
Exclusion criteria
Exclusion criteria: 1.Participants with history of infection in the affected joint that may affect the function of the implanted prosthetic. 2.Participants having less than optimal bone stock on femoral or tibial surfaces resulting from a history of disease, infection, or prior surgical procedures which cannot provide adequate support for the implantation. 3. Participants having compromised skeletal bone quality. 4. Participants having neuropathic disease that adversely affects the prosthetic joint. 5. Participants having osteoporosis or deficiency of musculature that compromises the affected limb. 6. Participants having pain-free and stable arthrodesis in an adequate functional position. 7. Participants having instable knee joint secondary to negative collateral ligament integrity. 8. Participants whose weight, age, or activity level might cause extreme loads and early failure of the system. 9. Participants unable or unwilling to provide written informed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Implant survivorship 2.Revision rate 3. Range of Motion 4.ComplicationsTimepoint: 1.Time Frame: 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years and 15 years 2. Time Frame: 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years and 15 years 3.Time Frame: Baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years and 15 years 4.Time Frame: Intraoperative, through discharge, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years and 15 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Visual Analogue Scale 2.Radiographic Assessment 3.Knee Society Score 4.12-item Short Form health survey 5.Forgotten Joint Score 6.Length of hospital stay 7.Adverse and serious adverse events 8.Laboratory AssessmentsTimepoint: 1.Time Frame: Baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years and 15 years 2.Time Frame: Baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years and 15 years 3. Time Frame: Baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years and 15 years 4.Time Frame: Baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years and 15 years 5.Time Frame: Baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years and 15 years 6.Time Frame: Discharge 7.Time Frame: Through discharge, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years and 15 years 8.Time Frame: Baseline | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed