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临床试验/NCT02791477
NCT02791477Unknown不适用

Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty

Vestre Viken Hospital Trust2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
65
试验地点
2
主要终点
Knee injury and Osteoarthritis Outcome Score - (KOOS)

研究概览

简要总结

Functional results with Attune Fixed Bearing Posterior Stabilized total knee arthroplasty evaluated with KOOS. A prospective longitudinal cohort study with repetitive measurements 6 weeks, 3, 6, 12 and 24 months postoperative.

详细描述

Total knee arthroplasty is a well documented and efficient treatment method for degenerative knee arthritis. Nevertheless it is reported that 15-20% of patients are not satisfied with the result. Some of the complaints are anterior knee pain, mid flexion instability and range of motion. Attune Fixed Bearing Posterior Stabilized knee have been developed to address the common complaints after knee arthroplasty surgery . The investigators like to use the Attune Fixed Bearing Posterior Stabilized knee with patella resurfacing on 65 of Our departments eligible patients to evaluate the functional results. Our primary outcome measure is change in Knee Osteoarthritis Outcome Score.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 50-80 years eligible for total knee arthroplasty at our hospital

排除标准

  • Patients unable to cooperate
  • Larger deformity that not suitable for a Posterior Stabilized total knee prostheses.
  • Revision operation
  • Diagnosed with inflammatory arthritis
  • Previously septic arthritis in the current knee joint
  • Local malignancy/general bone metastases
  • Serious Medical conditions that inflict on the walking ability
  • Active infections, latent infections og increased risk og infection
  • Previously arthrodeses or not well functioned arthroplasties in hips, knees or ankles.
  • Neurologic illness with symptoms from the current limb

结局指标

主要结局

Knee injury and Osteoarthritis Outcome Score - (KOOS)

时间窗: 2 years postoperative

Knee injury and Osteoarthritis Outcome Score

次要结局

  • University of California Los Angeles-Activity score(2 years postoperative)
  • Visual Analogue Scale Satisfaction (VAS-satisfaction)(2 years postoperative)
  • Quality of Life (EQ-5D)(2 years postoperative)
  • 40 meters walking functional test(2 years postoperative)
  • Forgotten Joint Score (FJS-12)(2 years postoperative)
  • Stair climbing test functional test(2 years postoperative)
  • 30 seconds stand up functional test(2 years postoperative)
  • Range of Movement (ROM)(2 years postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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