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临床试验/NCT02276118
NCT02276118Unknown不适用

Comparisons of Prosthesis Fitness, Early Recovery Patterns, Functional Outcomes and Patient Satisfaction Between E.Motion-Pro, a New Mobile Bearing System and Genesis II, an Established Successful System

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2014年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
knee swelling (circumference measured at the knee) at 3 months

研究概览

简要总结

Recently, E.Motion-PS-Pro (B.Braun-Aesculap, Tuttlingen, Germany), a new mobile bearing knee system with a unique ball and socket post-cam mechanism was developed for use in total knee arthroplasty. This study aims to determine (1) whether the use of E.Motion-PS-Pro improves prosthesis fitness for the femur and tibia in terms of under- or over-hang incidence compared to an established successful prosthesis, Genesis II (Smith & Nephew, Memphis, U.S.A.), (2) whether patients with this new prosthesis experience less pain and faster wound healing in early recovery phase, (3) whether patients with E.Motion-Pro reach functional plateaus faster than patients with Genesis II and the functional plateaus of patients with E.Motion-Pro are higher than those of patients with Genesis II.

详细描述

Total knee arthroplasty (TKA) is a satisfactory treatment option for patients with advanced knee diseases that are intractable with other modalities in terms of pain relief, functional restoration, and deformity correction. Unfortunately, however, many patients have to go through a recovery period of several months during which they experience considerable pain and suffer from incompletely restored functions. In recent years, to improve the quality of life during early recovery period after TKA, great efforts have been made in multiple areas including the use of minimally invasive surgical technique, improved pain management protocols, and postoperative rehabilitation protocols. Nonetheless, this almost inevitable presence of painful and disabling recovery period is a major concern to patients scheduled for or considering TKA as a treatment option. Furthermore, this issue can become a more serious obstacle to very elderly patients who have to balance the benefits of remaining years with improved functions from replaced knees and the burden of recovery duration after TKA.

In theory, the use of a better fitting prosthesis with sound kinematic performance can shorten the duration of recovery period and improve the quality of life by reducing pain and facilitating functional recovery. Better fitting prostheses allegedly less involve prosthesis overhang at femoral condylar level, which can cause impingement symptoms and at anterior flange area, which can cause patellofemoral symptoms. Prosthesis providing better kinematic performance such as natural motion and joint stability throughout motion arc can reduce pain and discomfort in early recovery period and shorten the duration of recovery period.

Recently, E.Motion-PS-Pro (B.Braun-Aesculap, Tuttlingen, Germany), a new mobile bearing knee system with a unique ball and socket post-cam mechanism was developed. This new prosthesis was designed to achieve better prosthesis fitting, to minimize bone loss from box preparations for post-cam mechanism, to improve joint stability throughout motion arc, particularly in high flexion, and to reduce the risk for wear and fracture at the post by increasing contact area. If the intended design rationales work out well, this prosthesis shall reduce soft tissue impingement and provide better kinematic performances, which reduces pain and facilitates functional restoration.

Therefore, the current investigators aim to determine (1) whether the use of E.Motion-PS-Pro improves prosthesis fitness for the femur and tibia in terms of under- or over-hang incidence compared to an established successful prosthesis, Genesis II (Smith & Nephew, Memphis, U.S.A.), (2) whether patients with this new prosthesis experience less pain and faster wound healing in early recovery phase, (3) whether patients with E.Motion-Pro reach functional plateaus faster than patients with Genesis II and the functional plateaus of patients with E.Motion-Pro are higher than those of patients with Genesis II. The investigators hypothesize that (1) E.Motion-Pro reduces the incidence of prosthesis under- or over-hang, (2) patients with E.Motion-Pro experience less pain and faster wound healing in early recovery phase, and (3) patients with E.Motion-Pro reach functional plateau faster and the functional outcomes at 1 year are better in patients with E.Motion-Pro than those with Genesis II.

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
Single (Participant)

入排标准

年龄范围
— 至 79 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who are decided to undergo total knee arthroplasty with diagnosis of primary osteoarthritis

排除标准

  • the diagnosis other than primary osteoarthritis
  • previous history of infection or trauma requiring surgical treatment on the knee which will receive total knee arthroplasty
  • patients of 80 years or older
  • patients with systemic diseases that can affect functional outcomes of TKA

研究组 & 干预措施

e.motion PS Pro group

Experimental

the patients who receives total knee arthroplasty with the e.motion PS pro prosthesis

干预措施: device: e.motion PS Pro (Device)

Genesis II group

Active Comparator

the patients who receives total knee arthroplasty with the Genesis II prosthesis

干预措施: device : Genesis II (Device)

结局指标

主要结局

knee swelling (circumference measured at the knee) at 3 months

时间窗: at 3 months after surgery

Knee swelling will be evaluated by measuring the leg circumference at the knee level (mid-patella), and the measured circumference will be compared with the preoperative circumference

the new American Knee Society (AKS) score at 6 months

时间窗: at 6 months after surgery

Patients will be evaluated at 6 months using the new scoring system of American Knee Society. The American Knee Society scoring system evaluates multiple aspects of outcomes: 1) Objective knee indicators (maximum points 80) - alignment (25), mediolateral (ML) stability (15), anteroposterior (AP) stability (10), range of motion (ROM) (30); 2) Knee score (maximum points 80) - symptoms (25), patient satisfaction (40), and expectation (15); 3) Function score (maximum points 100) - walking \& standing (30), standard activities (30), advanced activities (25), discretionary knee activities (15)

prosthesis fit

时间窗: from the start to end of surgery (expected average of 90 minutes)

Component fitness will be evaluated by whether there is overhang (too wide or big) or underhang (too narrow or small) more than 2 mm at any of three sites: condyle, junction, and anterior flange

pain level during gait at 3 months after surgery

时间窗: at 3 months after surgery

Pain levels will be evaluated by asking how much pain patients feel during weight bearing gait at 3 months in 0-10 visual analog scale (0-no pain and 10-maximum pain)

flexion contracture and maximum flexion at 3 months

时间窗: at 3 months after surgery

Flexion contracture and further flexion will be measured by a single investigator using a 38-cm clinical goniometer with patients supine

次要结局

  • pain level during motion arc exercise at 2 and 6 weeks(at 2 and 6 weeks after surgery)
  • knee swelling at 2 and 6 weeks(at 2 and 6 weeks after surgery)
  • whether balanced gaps were achieved(from the start to end of surgery (expected average of 90 minutes))
  • patient satisfaction with early recovery pattern at 3 months(at 3months after surgery)
  • flexion contracture and further flexion at 6 weeks, and 6, 12, 24 months(at 6 weeks, and 6, 12, 24 months after surgery)
  • tourniquet time(from the start to end of surgery (expected average of 90 minutes))
  • hemoglobin drop on postoperative 2 and 5 days(at 2 and 5 days after surgery)
  • need for walking aid at 6 weeks(at 6 weeks after surgery)
  • patient satisfaction with replaced knees at 12 and 24 months(at 12 and 24 months after surgery)
  • blood volume drained via a vacuum drainage in the subcutaneous tissue(from the end of surgery to removal of vacuum drainage (usually at 2 days after surgery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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