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. Arthroscopy Knee System implants are intended to be used in both men and non-pregnant women of age 18 years or above. 2. The Participants who are eligible for the arthroscopy system which is used in the surgical procedures related to knee ligament fracture fixation are included in the study. 3. The Participants who require connective tissue tendon repairs for the knees. 4. Participants who require the attachment of soft tissue grafts or bone-tendon grafts to the tibia and/or femur during cruciate ligament reconstruction surgeries and fixation of soft tissue. 5. The patient is willing and able to comply with postoperative scheduled clinical evaluations.
Exclusion criteria
Exclusion criteria: 1.Systemic or acute or chronic infection at the surgical site. 2. Known allergy or sensitivity to product materials. 3. Insufficient tissue coverage in the surgical area. 4. Any medical or surgical condition that would preclude the potential benefit of the operation. 5. Fever or leukocytosis. 6. Long-term infection, pregnancy and nursing, radiation bone therapy, cardiovascular diseases, metabolic bone disease, renal diseases, and pediatric Participants should not be included in the study. 7. Participants within whom cooperation or mental competence is lacking, thereby reducing Participants compliance. 8. The Participants, being considered for treatment by a doctor, would not comply with the follow-up schedule. 9. Participants who is unwilling or unsuitable for postoperative instructions. 10. The Participants who is unwilling or unable to sign the Informed Consent Document will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Implant failure rate 2.Reoperation rate 3.Physical FunctionTimepoint: 1.Time Frame: Intra-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years 2.Time Frame: 3 weeks, 3 months, 6 months, 1 year, 2 years 3.Time Frame: Pre-operative, 3 weeks, 3 months, 6 months, 1 year, 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Implant failure rate 2.Reoperation rate 3.Physical Function 4.Pain Score 5.Wound Complications 6. Intra-operative Complications 7.Length of Hospital Stay 8. SF-12 Questionnaire 9. Radiographic AnalysisTimepoint: Timeframe- Pre Operative, Intra Operative, Discharge, Post Operative, 3 week, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed