NCT02625311已完成4 期
A Prospective Comparative Randomized International Multicenter Study Comparing MIS Computer Navigated Total Knee Arthroplasty vs Conventional Computer Navigated Total Knee Arthroplasty
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- blood loss
研究概览
简要总结
Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis.
Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.
详细描述
Study executed with 3 centers and 69 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient requiring Total Knee Arthroplasty (TKA)
- •patients with Osteo arthritis
- •intact collateral ligaments and patella tendon
- •patients willing and able to comply with the post-operative schedule
排除标准
- •patients who require a revision TKA
- •patients with TKA contralateral knee within 6 months with bad outcomes
- •patients who need a TKA on contralateral side within 2 years
- •intraoperative resurfacing of patella
- •intraoperative eversion of patella
- •patients who had prior procedure of involved knee such as high tibial osteotomy, cruciate ligament recontruction, knee fusion or patellectomy
- •BMI > 30
- •patients with fixed flexion contracture> 15 degrees
- •patients with deformity greater than 20 degrees of varus or 15 degrees of valgus
- •Patient with Mediolateral stability > 10 degrees patient with active or suspected malignancy
- •patient with Rheumatoid arthritis
- •patient with systemic disease that would effect subject's wellfare or overall outcome of the study
- •patient with other severe concurrent joint involvement which can effect their outcome
- •patients with an immobile hip
- •patient with a history of Pulmonary embolism or Deep venous thrombosis
研究组 & 干预措施
MIS
Experimental
Minimal invasive surgery for placement total knee prosthesis
干预措施: surgery method using CR TKP (Procedure)
conventional approach
Active Comparator
conventional "open" surgery for placement total knee prosthesis.
干预措施: surgery method using CR TKP (Procedure)
结局指标
主要结局
blood loss
时间窗: 24 hours after surgery
measurement of milliliters blood loss during the first 24 hours after surgery
range of motion
时间窗: pre-op vs post-op until 5 years post-op
measurement of flexion and extension in degrees
次要结局
- chair rise and stair climb test(pre-op vs post-op until 5 years post operative)
- patient questionnaire(pre-op vs post-op until 5 year post operative)
研究者
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