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
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
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
相似试验
撤回
不适用
Comparing the Outcomes of Laparoscopic Cholecystectomy vs. Robotic CholecystectomyGallbladder DiseasesNCT03160157University of Illinois at Chicago
已完成
不适用
Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design IterationBone Conduction DeafnessUnilateral DeafnessMiddle Ear DeafnessMixed Hearing LossNCT03807713Oticon Medical25
撤回
不适用
Minimally Invasive Surgery Versus Traditional Open Surgery In The Treatment Of Single Level Lumbar StenosisIntervertebral Disc DegenerationLumbar Spinal StenosisNCT04408846Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
已完成
不适用
A Comparison of Single Port and Four Port Laparoscopic Gallbladder RemovalCHOLELITHIASISNCT01489436Mayo Clinic118
已完成
不适用
Comparison of Surgical Outcomes Between MPCNL and RIRSRenal StoneNCT02067221Seoul National University Hospital70