Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. The Subject is a male or non-pregnant female aged 18 years or older at the time of study. 2. The Subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent Form in the presence of an impartial witness. 3. The Subject is eligible for a partial arthroplasty only. 4. The Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations. 5. The Subject has non-inflammatory degenerative joint disease, including osteoarthritis, traumatic arthritis, or avascular necrosis. 6. The Subject has an inflammatory degenerative joint disease, excluding severe rheumatoid arthritis. The Subject has functional deformities such as varus, valgus, or flexion deformities. 8. The Subject has fractures that are unmanageable using other techniques. 9. The Subject has a correction of functional deformities.
Exclusion criteria
Exclusion criteria: 1. The Subject with a BMI greater than or equal to 40. 2. Subjects with a known sensitivity to device materials. 3. The Subject is unwilling or unable to sign the Informed Consent Document. 4. The Subject has a history of infection in the affected joint that may affect the function of the implanted prosthetic. 5. Subjects with less-than-optimal bone stock on femoral or tibial surfaces resulting from a history of disease, infection, or prior surgical procedures non-conducive towards adequate support for the implantation. 6. Any Subject has compromised skeletal bone quality. 7. Any Subject has neuropathic disease that adversely affects the prosthetic joint. Any Subject has osteoporosis or a deficiency of musculature that compromises the affected limb. 9. Any Subject with pain-free and stable arthrodesis in an adequate functional position. 10. Any Subject with unstable knee joint secondary to negative collateral ligament integrity. 11. Any Subject, being considered for treatment by a doctor, would not comply with the follow-up schedule. 12. Subjects with rheumatoid arthritis shall be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Range of Motion 2.Implant Survivorship 3. Cumulative Revision Rate 4. Intra-operative complicationsTimepoint: 1. Time Frame: Pre-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years 2. Discharge, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years 3. Time Frame: 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 5 years 4. Time Frame: During procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Knee Society Score 2. Oxford Knee Score 3. Pain 4. Technical Difficulties Encountered During Device Implantation 5. Postoperative complications 6. Type of Procedure 7. Subsequent requirement TKR 8. Length of hospital stay 9. SF-12 Questionnaire 10. Radiographic Analysis 11. Adverse Events 12. MetallosisTimepoint: Time Frame: Pre-operative, Postoperative, Discharge, 3 weeks, 3 months, 6 months, 1 year, 2 years, 3 years and 5 years | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed