CTRI/2020/01/022870已完成未知
Comparison of functional and radiological outcomes of total knee arthroplasty performed by robotic arm and computer navigation. A prospective randomized study
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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)
- •11.Subject is pregnant or plans to become pregnant during the study.
- •12.Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse.
- •13.Subject has a BMI >40.
- •14.Subject is enrolled in another investigational drug, biologic, or device study.
- •15.Subject is facing current or impending incarceration.
- •16.Subject has an inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia.
研究者
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