Multi-Center Prospective Clinical and Radiographic Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in Tegner activity score
研究概览
简要总结
The results of this study will optimize the care for patients with a meniscus root tear. Surgeons will be able to determine if MRR (meniscus root repair) with transtibial pullout technique is an effective treatment and will identify potential risk factors for poor clinical outcomes. In addition, investigators will determine if MRR is successful in delaying the radiographic progression of arthritis in the involved compartment.
详细描述
The loss of attachment at the root of the meniscus impairs the ability to maintain hoop strain when the tibiofemoral joint is loaded. This loss of hoop strain is responsible for the increased pressure on the articular cartilage.
This new awareness has prompted surgeons to consider surgical repair for treatment of meniscal root avulsions. Despite this recent focus on results of surgical repair, prospective studies are lacking, and the optimal surgical indications and technique have not been optimized.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meniscus root avulsion tear (defined as meniscus posterior horn root avulsion or full thickness tear within 9 mm of the root attachment)
- •Ligament injury with concomitant reconstruction is acceptable
- •Malalignment with corrective osteotomy is acceptable
排除标准
- •Subchondral collapse on pre-op MRI
- •Extrusion greater than 3 mm
- •Intra-op Outerbridge grade 3 or greater chondromalacia
- •Intra-op poor quality meniscus tissue
- •Mal-alignment greater than 5 degrees without corrective osteotomy
- •Obesity with BMI over 40
- •Kellgren Lawrence > grade 2
- •Worker's compensation status
研究组 & 干预措施
Transtibial pullout technique
Evaluation of the clinical and radiographic outcomes for patients undergoing a meniscus root repair (MRR) using a transtibial pullout technique.
干预措施: Transtibial pullout technique (Procedure)
结局指标
主要结局
Change in Tegner activity score
时间窗: baseline, 2 years
Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. The score varies from 0-10. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports \>6 score can only be achieved if the person participates in recreational or competitive sport.
次要结局
未报告次要终点
研究者
Daniel B. F. Saris
Professor of Orthopedics
Mayo Clinic