Health Condition 1: 8- Other Procedures
Conditions
Interventions
Intervention1: First arthroscopy to generate primary culture of autologous chondrocytes.: Healthy cartilage tissue biopsy of patients enrolled for the trial at KS Hegde Charitable Hospital
Mangalore will be taken during the first arthroscopy to generate primary culture of chondrocytes. In brief, healthy cartilage fragments (~3 4 mm ) somewhat away from the focal articular lesions and in
Sponsors
Dr Pruthvi K P
Prof Dr Praveenkumar Shetty
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must display a symptomatic, isolated cartilage lesion grade III-IV, ranging from 2 to 8 cm2 on the femoral condyle, trochlea, patella, or tibial plateau. 2. Patients must be ready to give consent in oral and written manner. 3. Stable knee joint or sufficiently reconstructed ligaments and no patella malalignment or sufficiently corrected patella malalignment. 4. Baseline score of less than 65 out of 100 in the overall KOOS
Exclusion criteria
Exclusion criteria: 1. ICRS grade II cartilage defects in the target knee. 2. Patients who have undergone prior biologic reconstructive procedures. 3. Subchondral bone defects more than 2 mm deep unless adjuvant defect filling performed prior to treatment. 4. Individuals consuming immunosuppressants, systemic or intra-articular steroids, and/or steroid use within 30 days prior to screening. 5. Individuals having metabolic arthropathies, autoimmune disease, immune suppression, history of or current relevant infections, chronic inflammatory arthritis and/or infectious arthritis, uncontrolled diabetes, systemic connective tissue disease, history of cancer, osteoporosis, primary hyperparathyroidism or Hyperthyroidism without satisfactory treatment, chronic renal failure or patients with prior pathological fractures, any degenerative muscular or neurological condition that would interfere with evaluation of outcome measures. 6. Pregnant women, Uncorrected malalignment in the target knee. 7. Degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade more than 2. 8. Joint space narrowing more that one third in the target knee when compared with the other knee or more than 3 mm joint space. 9. Arthrofibrosis in the target knee. 10. Diffuse chondromalacia grade 1 according to outerbridge allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Structural regeneration of articular cartilage at the defect site which could be assessed by MRI-based cartilage repair scoring (e.g., Magnetic Resonance Observation of Cartilage Repair Tissue score or T2 mapping: advanced, contrast-free MRI technique) at 6 12 months post-transplantation. 2. Functional improvements in the treated knee measured by standardized scales such as: Knee Injury and Osteoarthritis Outcome Score (KOOS) or International Knee Documentation Committee (IKDC) score. These scores will be evaluated at baseline and at various follow-ups up to months.Timepoint: Base line, 3 months, 6 months and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in pain quantified by Visual Analog Scale (VAS) or Numeric Pain Rating Scale (NPRS).Timepoint: 3 months, 6 months and 12 months;Improved range of motion and knee joint biomechanics, measured via gait analysis or physical performance tests.Timepoint: 3 months, 6 months and 12 months;Quality of life improvement, assessed through the Short Form-36 (SF-36) or EQ-5D questionnaire. Timepoint: 3 months, 6 months and 12 months;Safety outcomes including absence of graft rejection, infection, or abnormal immunogenic response to HAM scaffold.Timepoint: Baseline, 3 months, 6 months, and 12 months | — |
Countries
India
Contacts
Public ContactProf Dr Praveenkumar Shetty
NITTE (Deemed to be University)
Outcome results
None listed