Observational study for the assessment of the patient specific instrumentation (Stryker PrePlan blocks) using Computer Assisted Navigation System (Stryker NAV3 Navigation Platform).
- Conditions
- Health Condition 1: null- Patients with primary or secondary Osteoarthritis who need Total Knee Arthroplasty and Patients undergoing primary knee arthroplasty
- Registration Number
- CTRI/2017/02/007863
- Lead Sponsor
- Stryker Global Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) <br/ ><br>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) <br/ ><br>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 Outcome Measures
Name Time Method 1. Amount of blood loss <br/ ><br>2. Functional assessment <br/ ><br>3. Mechanical axis and component position assessment on x ray scannogram and CT scan <br/ ><br>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.