Evaluating the Efficacy of Preoperative Cryoneurolysis With Iovera on Postoperative Pain, Function, and Opioid Use Following ACL Reconstruction With Bone-Patellar Tendon-Bone Autograft
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
The purpose of this research study is to assess whether cryoneurolysis will help control pain after ACLR surgery and decrease the need of opioid medications. The primary objective is to compare postoperative functional recovery between Iovera and sham arms at 1 month after ACLR.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-45 years
- •Scheduled for primary ACLR with BPTB autograft
- •Willingness and ability to participate in Iovera
- •No chronic opioid use preoperatively
- •No known neurologic disorders affecting the lower extremity
- •Capacity and willingness to provide informed consent and comply with follow-up schedules
排除标准
- •Prior surgery on the affected knee.
- •Non-English speaking if validated PRO instruments at the site are only available in English; include validated translations if available and approved.
- •Contraindications to cryoneurolysis (e.g., cryoglobulinemia, cold urticaria, Raynaud's phenomenon, paroxysmal cold hemoglobinuria) or to local anesthetics.
- •Active skin infection, dermatitis, or compromised skin integrity at or near treatment sites.
- •Bleeding diathesis or anticoagulant therapy not compatible with minor percutaneous procedures per institutional policy.
- •Pregnancy or breastfeeding.
- •Known peripheral neuropathy or significant sensory deficit of the target region.
- •Any condition that, in the investigator's judgment, increases risk or interferes with participation
- •Concomitant use of other opioid drugs or prior chronic use.
结局指标
主要结局
Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline, 1 Month
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Difference in Lysholm knee scoring scale (LKSS)
时间窗: Baseline, 1 Month
The Lysholm knee scoring scale is a 100-point patient-reported questionnaire designed to assess functional knee ligament injuries. It evaluates eight areas - limp, support, locking, instability, pain, swelling, stair climbing, and squatting - with higher scores (up to 100) indicating better function.
次要结局
- Change in Visual Analogue Scale (VAS) for Pain score(Baseline, Post-operative Day 1)
- Cumulative opioid consumption as measured by morphine milligram equivalents (MME)(Up to 21 days post-operative)
- Change in Visual Analogue Scale (VAS) for Pain score(Baseline, Week 3)
- Change in Visual Analogue Scale (VAS) for Pain score(Baseline, Month 6)
- Change in Numeric Rating Scale (NRS)(Baseline, Post-operative Day 1)
- Change in Numeric Rating Scale (NRS)(Baseline, Week 3)
- Change in Numeric Rating Scale (NRS)(Baseline, Month 6)