Health Condition 1: null- Patients with primary or secondary Osteoarthritis who need Total Knee Arthroplasty and Patients undergoing primary knee arthroplasty
Conditions
Interventions
Intervention1: We perform TKR using Strykers PrePlan Blocks (Patient Specific Instrumentation) and then we confirm the technical axis by navigation method: PrePlan Blocks are patient specific instrume
Sponsors
Stryker Global Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with primary or secondary Osteoarthritis who need Total Knee Arthroplasty 2.Patients undergoing primary knee arthroplasty 3.Patients willing to give consent for the study
Exclusion criteria
Exclusion criteria: 1. Patient has a Body Mass Index (BMI) >= 30. 2. Patient age greater than or equal to 80. 3. Patient has a varus or valgus deformity greater than 45o or flexion contracture greater than 45o. 4. Patient participated in an orthopaedic clinical intervention involving the hip or knee joint in the last 12 months. 5. Patient had prior procedure of high tibial osteotomy, cruciate ligament reconstruction or patellectomy of the surgical knee. 6. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Pagetâ??sDisease) leading to progressive bone deterioration. 7. Prior diagnosis of neurologic disease affecting limb strength 8. Patient has a known sensitivity to device materials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the Mechanical axis in TKR patients implanted with Patient Specific Instruments by means of Computer Assisted Navigation System(Stryker NAV3 Navigation Platform) 2. To assess the component position in TKR patients implanted with Patient Specific Instruments by means of Computer Assisted Navigation System (Stryker eNlite Navigation System) 3. To measure the resection thickness of tibia and femur from bony landmarks after resecting the bone in Patient Specific InstrumentsTimepoint: Clinical and radiological evaluation of all patients will be carried out at 2 weeks, 3 months and 6 months after surgery. CT scan of knee will be done at 2 weeks after surgery or before discharge whichever is earlier.y | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amount of blood loss 2. Functional assessment 3. Mechanical axis and component position assessment on x ray scannogram and CT scan 4. Operative timeTimepoint: Post operatively, patients will be called to the out-patient department at predetermined intervals for assessment. Clinical and radiological evaluation of all patients will be carried out at 2 weeks, 3 months and 6 months after surgery. CT scan of knee will be done at 2 weeks after surgery or before discharge whichever is earlier. | — |
Countries
India
Contacts
Public ContactVivek Malhotra
AIIMS, New Delhi
Outcome results
None listed