Association of Pre-operative Genicular Nerves Cryoneurolysis With Improved Pain and Function in Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in pain severity
研究概览
简要总结
Approximately 20-30% of patients experience persistent pain after a Total Knee Arthroplasty (TKA). This study investigates whether percutaneous cryoneurolysis of genicular nerves can reduce pain and improve physical function when performed at least 24 hours before surgery. Participants will be randomized to receive either the cryoneurolysis procedure + TKA or TKA only. Results will be tracked for 6 months to see if the intervention improves long-term recovery and quality of life.
详细描述
The current study is a prospective, single-center, randomized comparative trial (1:1 ratio). In the intervention group, cryoneurolysis is performed under imaging guidance targeting the upper lateral and medial and the lower medial genicular nerves. Under prophylactic antibiosis, and imaging guidance 17Gauge cryoprobes will be percutaneously placed at the level of the upper lateral and medial and the lower medial genicular nerves. The final position of each cryo probe will be verified with imaging guidance. Cryoneurolysis protocol will be 5min freezing-4min passive thawing-5min freezing. Post-interventional imaging will verify lack of potential immediate complications
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
- Single (Outcomes Assessor)
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
- •Adults ≥18 years undergoing primary TKA for osteoarthritis.
- •Cognitively normal and able to self-assess pain and function.
- •Provide written informed consent.
排除标准
- •Cancer-related knee pain.
- •Neurological, psychiatric, or medical conditions interfering with assessment.
- •Chronic opioid users.
研究组 & 干预措施
Control Arm
Standard total knee arthroplasty without preoperative cryoneurolysis.
Cryoneurolysis + TKA Arm
CT-guided cryoneurolysis of upper medial, upper lateral, and lower medial genicular nerves ≥24 hours before TKA.
干预措施: CT-guided Cryoneurolysis of the Genicular Nerves (Procedure)
结局指标
主要结局
Change in pain severity
时间窗: 1 month postoperatively
Change in pain severity (Brief Pain Inventory-BPI) - Baseline to 1 month postoperatively. The BPI typically assesses two primary domains using a 0 to 10 numerical rating scale: Pain Intensity: Patients rate their pain at its "worst," "least," and "average" over the last 24 hours, as well as their pain "right now." 0 = No Pain 10 = Pain as bad as you can imagine Pain Interference: Patients rate how much their pain interferes with seven daily activities (General Activity, Mood, Walking Ability, Normal Work, Relations with others, Sleep, and Enjoyment of Life). 0 = Does not interfere 10 = Completely interferes Because higher numbers represent more intense pain and more significant disruption to life, a reduction in score over time is the goal of most clinical treatments.
次要结局
- Knee Injury and Osteoarthritis Outcome Score(3 and 6 months post-op)
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(3 and 6 months post-op)
- The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Classification System(6 months post-op)
研究者
Vasileios Balomenos
PhD Candidate
Attikon Hospital