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临床试验/NCT05013970
NCT05013970撤回不适用

Transcatheter Arterial Embolization as a Treatment for Knee Pain in Patients With Mild to Moderate Osteoarthritis

Universitaire Ziekenhuizen KU Leuven0 个研究点开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

研究概览

简要总结

Disabling symptoms of osteoarthritis are seen in approximatively 10% of people over 55 years old. Many patients suffer from persistent pain symptoms from moderate osteoarthritis despite optimal medical treatment. For these patients, several minimally-invasive surgical treatments have been proposed, including arthroscopic lavage and debridement; however, none of these treatments have been proven effective compared to sham treatment.

Recently, catheter-directed embolotherapy of the geniculate arteries has been propagated as a real alternative to medical management in patients with mild to moderate knee osteoarthritis unresponsive to conservative medical management.

详细描述

Disabling symptoms of osteoarthritis are seen in approximatively 10% of people over 55 years old. Traditionally, treatment of symptomatic knee osteoarthritis is based on administration of pain relievers, including nonsteroidal anti-inflammatory drugs, in case of mild to moderate symptoms; major joint replacement surgery (total joint arthroplasty) is performed in cases of severe and end-stage osteoarthritis.

However, many patients suffer from persistent pain symptoms from moderate osteoarthritis despite optimal medical treatment. For these patients, several minimally-invasive surgical treatments have been proposed, including arthroscopic lavage and debridement; however, none of these treatments have been proven effective compared to sham treatment.

Recently, catheter-directed embolotherapy of the geniculate arteries has been propagated as a real alternative to medical management in patients with mild to moderate knee osteoarthritis unresponsive to conservative medical management.

Transcatheter embolotherapy was performed using imipenem/cilastin sodium or 75 micron calibrated Embozene microspheres and follow-up was performed by physical examination, questionnaires (VAS-score and WOMAC-scores) and MR-imaging (WORMS-score). Results of these trials confirmed that catheter-directed embolotherapy is a safe procedure without any major adverse events. WOMAC pain scores dropped dramatically from 12.2 +/- 1.9 before the procedure to 3.3 +/- 2.1 at 1 month after the procedure and to 1.7 +/- 2.2 at 4 months after the procedure. Additionally, MR imaging at 2 years of follow-up could not demonstrate any osteonecrosis or progression of degenerative changes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of knee pain
  • Kellgren-Lawrence (KL) grade 1-3 assessed by weight-bearing knee radiographs
  • Local tenderness around the knee
  • Clinical failure after 3 months or more of conservative therapies, including oral nonsteroidal anti-inflammatory drugs and/or oral opioid agents and physical therapy, stretching, muscle strengthening and/or intra-articular injection of hyaluronic acid
  • Persistent moderate to severe knee pain (VAS > 50 mm) for more than 3 months
  • Patient is able to give consent

排除标准

  • Previous knee surgery
  • Local infection
  • BMI > 40 kg/m2
  • Advanced atherosclerosis
  • Rheumatoid arthritis, malignancy, renal insufficiency, other conditions contra-indicating femoropopliteal angiography
  • Usage of anticoagulants such as eliquis or coumarine (Asaflow allowed)
  • Allergy to iodinated contrast medium or any other allergy

结局指标

主要结局

Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

时间窗: Within 30 days after catheter-directed embolization

To evaluate symptoms and limitations in patients with knee osteoarthritis

Visual Analog Scale (VAS) for Knee Pain

时间窗: Within 30 days after catheter-directed embolization

To measure pain in patients with knee osteoarthritis

MRI imaging

时间窗: At day 30 after catheter-directed embolization

To depict potential asymptomatic, but radiologically visible side-effects

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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