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临床试验/NCT07319546
NCT07319546
招募中
不适用

Effectiveness of Accelerated Rehabilitation on Knee Joint Function and Quality of Life in Individuals With Total Knee Arthroplasty: A Double Blind Randomized Controlled Trial

Mahidol University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年12月1日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
Knee injury and Osteoarthritis Outcome Score (KOOS)

概览

简要总结

The primary aim of this double-blind randomized controlled trial is to evaluate the effectiveness of an accelerated rehabilitation protocol on knee joint function and quality of life in individuals undergoing TKA compared to conventional rehabilitation in Dali, Yunan, China. The study will include patients aged 50-80 years who are scheduled for primary unilateral TKA. Participants will be randomly assigned to either an accelerated rehabilitation group or conventional rehabilitation group. The primary outcomes will include knee joint function, assessed using the KOOS and quality of life measures using the SF-36 surveys. The study will follow participants for 6 months post-surgery to assess longer-term outcomes. This study will not include individuals undergoing revision TKA or those with severe comorbid conditions. The results will provide critical insights into the role of accelerated rehabilitation in improving post-operative recovery, functional outcomes, and overall quality of life for TKA patients.

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

入选标准

  • Patients diagnosed with end-stage knee OA necessitating primary unilateral TKA.

排除标准

  • History of joint infections, cancer, or inflammatory arthritis.
  • End-stage OA from rheumatoid or septic arthritis.
  • Individuals with neurological disorders such as Alzheimer's disease, - Parkinson's disease, stroke.
  • Individuals who are unable to follow a structured rehabilitation protocol.
  • Previous history of knee surgeries (other than arthroscopy).
  • Severe comorbidities that would hinder participation (e.g., advanced cardiovascular diseases).
  • Individuals who have severe osteoporosis.

结局指标

主要结局

Knee injury and Osteoarthritis Outcome Score (KOOS)

时间窗: From enrollment to the end of 6-month follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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