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临床试验/NCT06617819
NCT06617819尚未招募不适用

Influence of Different Prostheses(CR Vs. PS) on Postoperative Clinical Functional Scores in Total Knee Arthroplasty Based on Extramedullary Femoral Osteotomy Techniques and Functionalist Alignment

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Knee Society Score, KSS

研究概览

简要总结

Exploring differences in knee function after surgery with different types of prostheses(Cruciate ligament retaining(CR) VS. posterior stabilizing(PS))

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
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45-80 years, any gender, BMI < 35 kg/m2
  • Initial diagnosis of bilateral knee OA (Kellgren-Lawrence classification grades 3 or 4). Patients who are to undergo simultaneous primary bilateral knee arthroplasty
  • Inversion deformity ≤ 15°
  • Posterior cruciate ligament integrity

排除标准

  • History of knee surgery (ligament, osteotomy, etc.)
  • knee flexion<90°.
  • flexion contracture of one knee > 10°
  • Comorbidity with other diseases, such as peripheral neuropathy, malignant tumors, rheumatism, etc.
  • Posterior cruciate ligament injury
  • Those assessed to be intolerant of surgery

结局指标

主要结局

Knee Society Score, KSS

时间窗: 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery

Use of Knee Society Score scales for assessment. Including pain, mobility, stability, the patient\&#39;s ability to walk, up and down the stairs, etc. on the assessment, 85-100 is excellent, 70-84 is good, 60-69 is pass, less than 60 is poor

次要结局

  • WOMAC(Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery)
  • Stride length(Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery)
  • Stride frequency(Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery)
  • Percentage of stance phase(Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery)

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu Zhihong

Professor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

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