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临床试验/NCT07727551
NCT07727551招募中不适用

Enhancing Functional Outcomes in Total Knee Arthroplasty: the Role of Preoperative Genicular Radiofrequency

Anesthesiology department Iris South Hospitals1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
1
主要终点
Postoperative Oxford Knee Score

研究概览

简要总结

Knee osteoarthritis (OA) is a degenerative joint disease characterized by progressive cartilage wear, leading to pain, stiffness, and joint swelling. It is highly prevalent in aging populations and is strongly associated with obesity and previous joint injury. OA affects millions of individuals worldwide, with incidence and prevalence increasing markedly with age and resulting in significant functional disability

The primary therapeutic goals in the management of knee osteoarthritis are pain reduction and improvement of joint mobility.

Total knee arthroplasty is considered one of the most effective surgical interventions for relieving pain and restoring function in patients with severe knee osteoarthritis. Nevertheless, residual pain and limited functional improvement remain the most frequent causes of patient dissatisfaction following TKA

Genicular nerve radiofrequency ablation (GNRFA) has emerged as an innovative treatment option for symptomatic knee osteoarthritis. This technique has been shown to reduce pain and improve function, with clinical benefits often observed as early as one week after treatment. GNRFA consistently provides short-term pain relief (3 to 6 months) and, in some cases, longer-lasting benefits.

The hypothesis tested in this study is whether GNRFA performed at least two weeks preoperatively can reduce postoperative pain and improve postoperative function.

详细描述

The International Association for the Study of Pain (IASP) has recently updated the definition of pain as "An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage." This definition is complemented by explanatory notes emphasizing the subjective nature of pain and its modulation by biological, psychological, and social factors. Pain may therefore have detrimental effects on physical function as well as on social and psychological well-being.

Chronic postsurgical pain (CPSP) is defined as pain that develops after a surgical procedure and persists for at least three months following surgery. Historically, the risk of developing CPSP has been underestimated. Available data indicate that the incidence of postsurgical pain ranges from 5% to 85%, depending on the type of surgical procedure. Severe CPSP occurs in approximately 2% to 15% of patients, with reported rates of 17-21% after abdominal surgery, 6-55% after caesarean section, 5-65% after thoracotomy, 27% after hip arthroplasty, and 13-20% after knee arthroplasty. Specifically, after total knee arthroplasty (TKA), pain severity tends to plateau between three and six months postoperatively.

Knee osteoarthritis (OA) is a degenerative joint disease characterized by progressive cartilage wear, leading to pain, stiffness, and joint swelling. It is highly prevalent in aging populations and is strongly associated with obesity and previous joint injury. OA affects millions of individuals worldwide, with incidence and prevalence increasing markedly with age and resulting in significant functional disability. Approximately 23% of individuals over 40 years of age are affected, with prevalence rising to nearly 80% in older populations. Major risk factors include aging, elevated body mass index (BMI), joint injury, repetitive joint overload, and genetic predisposition. Since the mid-20th century, both prevalence and incidence have doubled, largely due to increased life expectancy and rising obesity rates.

The primary therapeutic goals in the management of knee osteoarthritis are pain reduction and improvement of joint mobility. Treatment follows a stepwise approach, including exercise therapy, weight reduction, physiotherapy, analgesics, nonsteroidal anti-inflammatory drugs, intra-articular corticosteroid or hyaluronic acid injections, arthroscopic procedures, and, in advanced disease, total joint replacement followed by structured rehabilitation.

Total knee arthroplasty is considered one of the most effective surgical interventions for relieving pain and restoring function in patients with severe knee osteoarthritis. Nevertheless, residual pain and limited functional improvement remain the most frequent causes of patient dissatisfaction following TKA. Both patients and surgeons may consider the procedure unsuccessful when long-term pain relief and functional recovery are inadequate. Furthermore, older adults experiencing chronic pain after TKA may suffer from impaired social relationships and social isolation. Chronic pain in this population is also associated with depression, anxiety, sleep disturbances, and long-term opioid use, all of which negatively affect health-related quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 60
  • Elective total knee arthroplasty
  • 2 to 6 weeks before the procedure
  • AND either of:
  • BMI > 35
  • Diabetes under insulin
  • Anxiety disorder
  • Treated depressive disorder
  • Widespread pain disorder or central sensitisation disorder
  • Chronic pain at a different site
  • Catastrophising
  • Sleep disorder
  • preoperative EVA 7 or more
  • OKS 25 or less
  • WOMAC 50 or more
  • Previous total knee arthroplasty (contralateral)
  • Knee CRPS

排除标准

  • Previous prosthetic surgery on the same knee (i.e. redo surgery, open reduction internal fixation, knee hemiarthroplasty)
  • Major psychiatric disorder (i.e. major depression, schizophrenia)
  • Patient refusal
  • Inability to communicate with the patient and obtain informed consent

结局指标

主要结局

Postoperative Oxford Knee Score

时间窗: Three months post-operative

A difference of 5 points in Oxford Knee Score between groups will be considered significant. Range: 0 to 48, higher is better

Western Ontario and McMaster Universities Osteoarthritis Index postoperative

时间窗: 3 months postoperatively

A 12 point difference will be considered significant Range: 0 to 96, higher is better

次要结局

  • Numerical rating scale pain postoperative(Three months post-operatively)
  • Chronic regional pain syndrome post-operatively(3 months post-operatively)
  • Morphine consumption(Three months post-operatively)
  • Patient satisfaction(Three months postoperatively)

研究者

发起方
Anesthesiology department Iris South Hospitals
申办方类型
Other
责任方
Sponsor

研究点 (1)

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