NCT07388290Enrolling By Invitation不适用
The Effect of Centralization on Medial Meniscal Extrusion for Medial Meniscus Posterior Root Tear Repair
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- Meniscus extrusion measurement
研究概览
简要总结
The purpose of this research is to determine if meniscus root repair with or without centralization will have an impact on postoperative pain, function, activity levels, patient satisfaction, and incidence of revision meniscus surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Medial Meniscus Posterior Root Tear demonstrated on MRI
- •Notable extrusion (>3 mm) on preoperative MRI
- •Patient able to consent for themselves
- •Patient agrees to comply with trial schedules and plan
- •Pre-operative Exclusion:
- •Concomitant ligamentous or meniscal procedures
- •Meniscal extrusion > 6 mm on pre-operative MRI
- •Kellgren-Lawrence grade > 2
- •Varus malalignment > 10 degrees
- •Asymmetric varus alignment > 5 degrees
- •Varus thrust while weightbearing
- •Grade 3 bipolar medial compartment changes (isolated grade 3 changes on single articular surface with ≤ grade 2 changes on the opposing surface remains eligible)
- •Previous surgery of the affected knee
- •Associated fractures requiring surgery
- •Concurrent Vascular injuries
- •Hypermobility/Ehlers-Danlos Syndrome
- •Inflammatory or autoimmune disease
- •Severe mental/physical disability precluding post operative rehabilitation demands
- •Contraindications to MRI
- •Pregnant women
- •Arthroscopy Inclusion Criteria:
- •Complete radial tears within 9 mm of medial meniscus posterior root
- •ICRS Grade 3 or better
- •Arthroscopy
排除标准
- •Requiring concomitant procedures other than MMPRT
- •ICRS Grade 4 changes
研究组 & 干预措施
Repair without centralization
Active Comparator
Medial meniscus posterior root tear (MMPRT) surgical repair without centralization
干预措施: Medial meniscus posterior root tear (MMPRT) repair without meniscus centralization (Procedure)
Repair with meniscus centralization
Experimental
Medial meniscus posterior root tear (MMPRT) surgical repair with meniscus centralization
干预措施: Medial meniscus posterior root tear (MMPRT) repair with meniscus centralization (Procedure)
结局指标
主要结局
Meniscus extrusion measurement
时间窗: Baseline (Preoperatively), 6 months
Meniscus extrusion is measured in millimeters (mm) on coronal MRI at the level of the tibial spine
次要结局
- Change in Kellgren-Lawrence grade on X-ray(Baseline (Screening), 12 months, 24 months)
- Change in Tegner Activity Score(Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Change in Visual Analog Scale (VAS) Questionnaire score(Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Change in Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS, JR) Questionnaire score(Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Change in International Knee Documentation Committee (IKDC) Questionnaire score(Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Change in Likert Knee Questionnaire score(Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Surgery Satisfaction Questionnaire(2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months)
研究者
研究点 (3)
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