ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY: A FEASIBILITY STUDY (KNEE EMBOLISATION)
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- arterial embolization
研究概览
简要总结
Recent works in interventional radiology have shown interesting results in the treatment of musculoskeletal inflammatory sites by arterial embolization. Supra-selective arterial embolization has been successfully developed by Dr. Okuno (Japan) to manage moderate to severe knee osteoarthritis. Also, inflammation of the surgical site mediated via geniculate arteries is a major cause for persistent chronic post-operative gonalgia.
详细描述
Hypothesis
Selective arterial embolization of persistent geniculate arteries could reduce chronic post-operative gonalgia after TKA with minimally invasive approach.
Objective
To evaluate the feasibility of selective arterial embolization of persistent geniculate arteries to reduce chronic post-operative gonalgia after TKA.
Material and methods
This study is a single-center, prospective, feasibility study. Patients will be recruited after rheumatology consultation for chronic post-operative gonalgia, more than 6 months after TKA for moderate to severe gonarthrosis. Eligible patients are adults with moderate to severe chronic post-operative gonalgia (Visual Analysis Scale (VAS) > 50mm) and degraded life quality (assessed by SF36 score), despite at least 3 months of optimal medical treatment. Non-inclusion criteria are mainly other rheumatologic or orthopedic severe diseases, severe surgical complications. Under local anesthesia, with homolateral antegrade femoral access, patient will undergo selective arterial embolization of persistent and aberrant peri-prosthetic arteries using HydroPearl® 200µm Mircospheres. Follow-up consultations will be scheduled at D1, M1, M3, M6 and M12. For a significance level of α=0.05 and power of 80% we require a cohort of 24 patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (male or female) aged 18-85
- •Suffering from moderate to severe chronic pain (EVA > 50mm) more than 6 months after total prosthetic knee replacement surgery for severe gonarthrosis with impact on quality of life.
- •And having followed for at least 3 months a well-conducted conservative medical treatment (anti-inflammatory, analgesic, masso-kinesiotherapy).
- •The patient may initially have had a single or bilateral replacement. The period of 6 months must be respected for each side, between the intervention and the inclusion for homolateral pain.
- •Patient willing to participate in the study and with signed informed consent.
- •Patient willing to undergo post-operative monitoring for one year.
排除标准
- •Orthopaedic or rheumatological pathologies:
- •Rheumatoid arthritis
- •Psoriatic rheumatism
- •Spondylarthropathies
- •History of primary or secondary bone tumor, in remission or active.
- •Operational criteria:
- •Infection of the surgical site
- •Re-operation
- •Severe bleeding
- •Use of turnstile per-operative
- •Wound of popliteal artery
- •Diabetic patient
- •Comorbidities:
- •General condition responsible for objective hemostasis disorder (hemophilia, Willebrand disease, thrombocytopenia) and anticoagulant treatments.
- •Pads 100 G/L
结局指标
主要结局
arterial embolization
时间窗: 12 MONTHS
次要结局
- VAS pain score(12MONTHS)
- Western Ontario and Universities Osteroarthritis Index (WOMAC) score(12MONTHS)
- SF36 quality of life score(12 MONTHS)