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Идёт набор NCT07727551

Preoperative Genicular Radiofrequency and Functional Outcomes After Total Knee Arthroplasty

Без фазы С лечением Total Knee Arthroplasty Secondary to Osteoarthritis 18 Years and Older

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 seconds.
Кому может быть актуально
Состояния в реестре: Total Knee Arthroplasty Secondary to Osteoarthritis, 18 Years and Older. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

The most relevant variables associated with the development of chronic pain following TKA can be broadly categorized into demographic and preoperative factors. Demographic factors include age and body mass index. Preoperative factors with strong supporting evidence include the severity of preoperative pain, chronic widespread pain, maladaptive health beliefs, sleep disturbances, central sensitization, anxiety, and impaired preoperative function.

Consequently, prevention of chronic pain after TKA relies on a multimodal, patient-centered approach initiated in the preoperative period. This strategy includes optimization of the patient's overall condition, active patient involvement in the surgical pathway, preemptive analgesia (such as peripheral nerve blocks and local anesthesia), optimization of surgical precision thanks to new devices (Rosa - Robotic Surgical Assistant), early initiation of physical therapy, effective management of acute postoperative pain using cryotherapy, limb elevation, and pharmacological treatment, as well as the integration of psychosocial support.

Among the various risk factors, particular attention should be given to the intensity of preoperative pain, which has been identified as a major predictor of CPSP. Strong evidence supporting this association has been reported in a systematic review published in 2024.

Preoperative pain management may be achieved through several approaches, including pharmacological therapy, physiotherapy, ketamine infusion, and locoregional anesthesia techniques such as genicular nerve blocks and adductor canal blocks. Among these modalities, radiofrequency-based interventions appear to provide the most sustained analgesic effects.

Electrical stimulation techniques have long been recognized for their analgesic properties. Among them, radiofrequency is one of the most widely used modalities in the treatment of chronic pain. Two main types of radiofrequency are currently employed: continuous and pulsed. Continuous radiofrequency (CRF) delivers continuous electrical stimulation, generating high temperatures (up to 80°C) at the target nerve or tissue, resulting in neural ablation. With increasing clinical experience, it became evident that effective pain control could also be achieved at lower temperatures. Subsequent research demonstrated that the therapeutic effect of pulsed radiofrequency (PRF) is primarily related to the electrical field generated around the target nerve rather than thermal ablation.

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.

Performing GNRFA at least one week prior to TKA, as part of a comprehensive multimodal perioperative strategy, can enhance surgical outcomes by reducing preoperative pain and improving functional status, thereby placing patients in a more favorable condition to undergo surgery.

Вмешательства

  • Процедура Radiofrequency ablation of the genicular nerve, 42 degrees Celsius for 120 seconds
    Radiofrequency ablation of the genicular nerves (upper medial, upper lateral and lower medial nerves), at 42 C for 120 seconds each, after injection of 5ml lidocaine 2% for each nerve.

Первичные конечные точки

  • Postoperative Oxford Knee Score [Срок оценки: Three months post-operative]
  • Western Ontario and McMaster Universities Osteoarthritis Index postoperative [Срок оценки: 3 months postoperatively]
Вторичные конечные точки (4)
  • Numerical rating scale pain postoperative [Срок оценки: Three months post-operatively]
  • Chronic regional pain syndrome post-operatively [Срок оценки: 3 months post-operatively]
  • Morphine consumption [Срок оценки: Three months post-operatively]
  • Patient satisfaction [Срок оценки: Three months postoperatively]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Бельгия · 1 центр
  • Iris South Hospitals — Brussels

Публикации

  • Murray DW, Fitzpatrick R, Rogers K, Pandit H, Beard DJ, Carr AJ, Dawson J. The use of the Oxford hip and knee scores. J Bone Joint Surg Br. 2007 Aug;89(8):1010-4. doi: 10.1302/0301-620X.89B8.19424. PMID 17785736
  • Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18. PMID 15208174
  • Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001 Aug;45(4):384-91. doi: 10.1002/1529-0131(200108)45:43.0.CO;2-0. PMID 11501727
  • Clement ND, Afzal I, Demetriou C, Deehan DJ, Field RE, Kader D. There is no clinically important difference in the Oxford knee scores between one and two years after total knee arthroplasty: The one-year score could be used as the benchmark timepoint to assess outcome. Knee. 2020 Aug;27(4):1212-1218. doi: 10.1016/j.knee.2020.05.015. Epub 2020 Jun 25. PMID 32711884
  • Jordan K, Dunn KM, Lewis M, Croft P. A minimal clinically important difference was derived for the Roland-Morris Disability Questionnaire for low back pain. J Clin Epidemiol. 2006 Jan;59(1):45-52. doi: 10.1016/j.jclinepi.2005.03.018. Epub 2005 Nov 4. PMID 16360560
  • Hasoon J, Orhurhu VJ, Yazdi C. Genicular Nerve Blocks for the Management of Chronic Knee Pain Related to Osteoarthritis - A Case Series. Orthop Rev (Pavia). 2024 Dec 3;16:126046. doi: 10.52965/001c.126046. eCollection 2024. PMID 39640541
  • Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11. PMID 36369781
  • GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available. PMID 18915634

Идентификаторы

NCT: NCT07727551 · CEHIS2026/05

Первоисточники (государственные реестры)

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