Health Condition 1: Z966- Presence of orthopedic joint implants
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil- Observational Study: Nil- Observational Study
Sponsors
ALKEM MEDTECH ORTHO PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult participants aged 18 to 75 years, of any gender. 2. Participants with a confirmed diagnosis of symptomatic knee osteoarthritis requiring total knee arthroplasty (TKA). 3. Participants who are eligible to undergo TKA using the ACTIKNEE knee implant in conjunction with high-quality bone cement, as determined at the investigator discretion and in accordance with standard surgical practice. 4. Written informed consent obtained from each participant prior to study enrollment. 5. Willing and able to comply with all study procedures, protocol requirements, and scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of prior knee arthroplasty or revision surgery in the target knee. 2. Patients with an active knee joint infection or a history of infection in the target knee within the past 12 months. 3. Patients with severe bone loss, bone deformity, or other structural abnormalities that would preclude proper implant placement, as determined by the investigator. 4. Patients with a history of systemic infection, immunodeficiency, or any other illness that significantly limits mobility or could interfere with postoperative recovery. 5. Patients with a known allergy or hypersensitivity to any component of the ACTIKNEE knee implant or bone cement. 6. Patients with significant uncontrolled comorbidities (e.g., poorly controlled diabetes mellitus, unstable cardiovascular disease, or other severe systemic illness) that, in the opinion of the investigator, could adversely affect surgical outcomes or compliance with follow-up. 7. Any patient who, in the opinion of the investigator, is not considered suitable for the study due to medical, psychological, or social reasons that may compromise safety, compliance, or study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the performance of the ACTIKNEE knee implant in terms of functional improvement and patient-reported outcomes following total knee arthroplasty. To evaluate the safety profile of the ACTIKNEE knee implant. To evaluate the effectiveness of the ACTIKNEE knee implant in providing pain relief following total knee arthroplasty.Timepoint: Primary Performance Endpoint: 1. Mean change from baseline in Knee Society Score (KSS) Knee Score at 6 months post-operative | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Achal Thul
Alkem Laboratories Ltd
Outcome results
None listed