A Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- KOOS Questionnaire
研究概览
简要总结
Meniscus does not always heal when sutured. The investigators will make small holes in the meniscus before repair to promote more bleeding. The investigators expect that will help the meniscus to heal better.
详细描述
RCT study to evaluate the effect on trephination together with meniscal repair on meniscus healing after repair.
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
- Double (Participant, Outcomes Assessor)
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
- •Adults who have a meniscus repaired.
排除标准
- •Meniscus not fit for repair.
- •Patients not fit for the repair regime.
- •Arthrosis > stadie 2 (ICRS).
- •Prior attempt of repair of the meniscus.
研究组 & 干预措施
Trephination
A 1 x 10 mm pricker are used for the trephination of the meniscus before normal meniscal repair.
干预措施: trephination (Procedure)
Normal meniscal repair
standard operation. Normal meniscalrepair.
干预措施: Normal meniscal repair (Procedure)
结局指标
主要结局
KOOS Questionnaire
时间窗: 12 month
Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.
KOOS Questionnaire
时间窗: 4 month
Primary outcome are differences between the to arms in the most relevant subgroup "Function, sports and recreational activities" in the KOOS questionnaire.
次要结局
- Clinical meniscus healing(4 month)
研究者
Mikkel Lindegaard Attrup
Staff Specialist 1
Amager Hospital