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临床试验/NCT07342166
NCT07342166已完成不适用

Effect of Patellar Denervation on Post-operative Knee Pain and Knee Function in Total Knee Arthroplasty: A Randomized Controlled Trial

Queen Savang Vadhana Memorial Hospital, Thailand1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Visual analog scale score for knee pain

研究概览

简要总结

This study is a double-blind randomized controlled trial aiming to investigate the effects of patellar denervation using electrocautery on postoperative knee pain and knee function in patients undergoing primary total knee arthroplasty (TKA) without patellar resurfacing.

详细描述

This study is a prospective, double-blind randomized controlled trial conducted at Queen Savang Vadhana Memorial Hospital between 2023 and 2025. The aim of the study is to assess the effect of patellar denervation using electrocautery on postoperative knee pain and knee function in patients undergoing primary total knee arthroplasty (TKA) without patellar resurfacing.

Sixty-four patients were enrolled and randomly assigned to either the patellar denervation group (PD) or the non-denervation group (NPD), with 32 participants in each group.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 55-85 years old
  • Knee osteoarthritis
  • Plan for total knee arthroplasty after failed conservative treatment for at least 3 months

排除标准

  • Previous history of trauma, fracture or open surgery on the same knee
  • Inflammatory arthritis or Crystal-induced arthritis
  • Patellar instability or isolated patellofemoral osteoarthritis
  • Unable to answer questionnaire
  • Cannot tolerate surgery due to medical comorbidities

结局指标

主要结局

Visual analog scale score for knee pain

时间窗: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months

次要结局

  • Kujala score(3 months, 1 year)
  • Knee Society score(3 months, 1 year)
  • Timed up and go test(3 months, 1 year)

研究者

发起方
Queen Savang Vadhana Memorial Hospital, Thailand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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