跳至主要内容
临床试验/NCT03037242
NCT03037242
Enrolling By Invitation
不适用

Multi-Center Prospective Clinical and Radiographic Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 55 人2017年5月1日

概览

阶段
不适用
干预措施
Transtibial pullout technique
疾病 / 适应症
Meniscus Tear
发起方
Mayo Clinic
入组人数
55
试验地点
2
主要终点
Change in Tegner activity score
状态
Enrolling By Invitation
最后更新
3个月前

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.

注册库
clinicaltrials.gov
开始日期
2017年5月1日
结束日期
2027年2月1日
最后更新
3个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Mayo Clinic
责任方
Principal Investigator
主要研究者

Daniel B. F. Saris

Professor of Orthopedics

Mayo Clinic

入排标准

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

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.

研究点 (2)

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