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临床试验/NCT04181216
NCT04181216Unknown不适用

Comparison of Anatomically Aligned and Conventional Total Knee Arthroplasty in the Same Patients

The Catholic University of Korea0 个研究点目标入组 100 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Change in Western Ontario and McMaster Universities Index(WOMAC index)

研究概览

简要总结

Total knee arthroplasty(TKA) is a successful orthopedic surgery with excellent clinical outcome and survival. However, there are concerns about patient satisfaction in previous reports, and dissatisfaction rate of 15-30% is reported in clinical outcomes(PROMs) of some studies. Therefore, for improving the patient's outcome and satisfaction after total knee arthroplasty, it is necessary to change the design of the conventional total knee arthroplsaty implant. The knee is a joint structure with several dynamic functions, and not only the skeletal structure but also the soft tissue balance plays an important role in the function of the knee joint. New implants are being developed to overcome the limitations of conventional TKA implant, including the Journey II Bi-cruciate substituting total knee system (JII-BCS; Smith & Nephew). JII-BCS implant has normal articular geometry, more anatomical femoral shape, lateral tibial convex geometry, and asymmetrical tibial plateau, anterior and posterior cams, which has been shown in experimental studies to produce nearly normal knee movement by reproducing the actual normal anatomical alignment in vivo.

The clinical results of the kinematic effects of this anatomcally aligned change are insufficient, and there is also a lack of comparative studies with conventional total knee arthroplasty implant. The purpose of this study is to compare outcomes between anatomically aligned TKA(JII-BCS) and conventional TKA(Legion total knee system, Smith & Nephew). This study is a randomized controlled study in patients undergoing total knee arthroplasty per day. Radiologic parameter, patients preference and clinical results was investigated in both knee of same patients who received TKA during minimum 2 year follow up.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients for bilateral total knee arthroplasty
  • having medicare insurance

排除标准

  • Rheumatoid arthritis
  • Other inflammatory arthritis
  • Crystal-induced arthritis
  • Septic arthritis
  • Neuropsychiatric patients
  • Previous knee operation history
  • Neuropsychiatric patients
  • Patients with preoperative severe limitation of motion (Flexion contracture ≥ 20, range of motion ≤ 90)
  • Patients with preoperative severe defomity of knee alignment (Varus or valgus angle ≥ 15)
  • Severe obese patients (BMI ≥ 40)

结局指标

主要结局

Change in Western Ontario and McMaster Universities Index(WOMAC index)

时间窗: Change from baseline score to score of postoperative1 year

次要结局

  • Change in Range of Motion(Change from baseline Range of Motion at postoperative1 year)
  • Change in Knee Society Score(Change from baseline score to score of postoperative1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong In

Professor

The Catholic University of Korea

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