CTRI/2020/01/022870
Completed
未知
Comparison of functional and radiological outcomes of total knee arthroplasty performed by robotic arm and computer navigation. A prospective randomized study
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: M171- Unilateral primary osteoarthritisof knee
- Sponsor
- Fortis Escorts Hospital
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subject is a candidate for unilateral primary total knee arthroplasty due to degenerative joint disease.
- •2\.Subject is willing to sign and date an EC\-approved consent form.
- •3\.Subject is male or female between the ages of 35 and 75 years of age.
- •4\.Subject plans to be available through 2 years post\-operative follow\-up.
- •5\.Subject agrees to follow the study protocol.
Exclusion Criteria
- •1\.Subject having deformity more than 20 degree in coronal and sagittal plane.
- •2\.Subject having history of revision knee for a previously failed total or unicondylar knee arthroplasty.
- •3\.Subject has a history of patellar fracture, patellectomy, patello\-femoral instability or high tibial osteotomy.
- •4\.Subject having any extra\-articular bony deformity in lower limbs.
- •5\.Subject has inflammatory arthritis.
- •6\.Subject possesses a contralateral or ipsilateral revision hip arthroplasty
- •7\.Subject has ipsilateral hip arthritis resulting in flexion contracture
- •8\.Subject has an active infection or sepsis (treated or untreated) or presence of malignant tumor , either primary or metastatic, or benign tumor on leg with knee to be treated
- •9\.Subject has conditions that may interfere with the TKA survival or outcome (e.g. Pagetââ?¬•s or Charcotââ?¬•s disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes mellitus i.e. not under treatment with oral/injectable medications to control blood glucose levels, fibromyalgia, moderate to severe renal insufficiency or neuromuscular disease)
- •10\.Subject has lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture)
Outcomes
Primary Outcomes
Not specified
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