Health Condition 1: M17- Osteoarthritis of knee Health Condition 2: M06- Other rheumatoid arthritis Health Condition 3: M130- Polyarthritis, unspecified
Conditions
Interventions
Intervention1: ACTIKNEE Knee Implant: The Total Knee Replacement System is intended for use in patients requiring knee joint replacement due to significant pain and functional limitation. It is indica
Sponsors
Alkem MedTech Ortho Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 to 75 years scheduled to undergo Total Knee Arthroplasty (TKA) using the ACTIKNEE knee implant in conjunction with high-quality bone cement. 2.Patients with a diagnosis of symptomatic knee osteoarthritis requiring TKA (grade 3 or grade 4 arthritis according to Kallgren and Lawrence grading system on standing x-ray of knee). 3.Patients willing and able to provide written informed consent. 4.Patients able to comply with the study protocol, including follow-up visits and assessments.
Exclusion criteria
Exclusion criteria: 1.Prior knee arthroplasty or revision surgery in the target knee. 2.Active or recent (within 12 months) knee joint infection. 3.Severe bone loss or bone deformity that would preclude proper implant placement. 4.HbA1c is greater than 8 percent at screening. 5.Hemoglobin less than 10 g/dL at screening. 6.Urine microscopy showing more than 5 pus cells per high-power field. 7.C-reactive protein (CRP) not within the normal range as per laboratory reference values. 8.Known allergy or hypersensitivity to implant materials. 9.Significant comorbidities that could preclude safe administration of anesthesia for surgical procedure. 10.HIV reactive subjects. 11.Subjects with progressive neurological disease or gross motor weakness that could impair mobility or affect outcome assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional improvement and patient-reported outcomes will be assessed using the following validated scoring systems: 1.Improvement in Knee Society Score (KSS) 2.Improvement in Oxford Knee Score (OKS) 3.WOMAC Index (Western Ontario and McMaster Universities Osteoarthritis Index) 4.Forgotten Joint Score (FJS)Timepoint: Subjects enrolled in this clinical investigation will be assessed at predefined timepoints over a 5-year follow-up period post-surgery. Data collection will occur at the following intervals: -Day 0 - preoperative (baseline), intraoperative and immediately postoperative (at surgery) -6 weeks -6 months -1 year -2 years -3 years -4 years -5 years At each visit, clinical evaluations, patient-reported outcomes, radiographic assessments (as applicable), and documentation of adverse events will be performed. All assessments will be recorded in the subject s CRF. Data will be analyzed to evaluate the safety, performance,and long-term outcomes of the ACTIKNEE Knee Implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Parameters: -Rate of implant loosening or failure -Frequency and severity of AEs and SAEs during study period. Additional Performance Parameters: -Pain reduction as measured by Visual Analog Scale (VAS) -Range of motion improvements assessed by goniometryTimepoint: Subjects enrolled in this clinical investigation will be assessed at predefined timepoints over a 5-year follow-up period post-surgery. Data collection will occur at the following intervals: -Day 0 - preoperative (baseline), intraoperative and immediately postoperative (at surgery) -6 weeks -6 months -1 year -2 years -3 years -4 years -5 years At each visit, clinical evaluations, patient-reported outcomes, radiographic assessments (as applicable), and documentation of adverse events will be performed. All assessments will be recorded in the subject s CRF. Data will be analyzed to evaluate the safety, performance,and long-term outcomes of the ACTIKNEE Knee Implant. | — |
Countries
India
Contacts
Public ContactDr Amandeep Singh Bakshi
Government Medical College & Rajindra Hospital
Outcome results
None listed