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临床试验/NCT02578589
NCT02578589Unknown不适用

Medial Plica Syndrome of the Knee: Conservative Treatment Versus Arthroscopic Plica Resection - a Randomized Controlled Multicenter Trial

Regionshospitalet Silkeborg4 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
72
试验地点
4
主要终点
Lysholm-Scale (Units on a scale)

研究概览

简要总结

The purpose of this trial is to evaluate the effect of conservative treatment in comparison to arthroscopic resection of pathological medial plicae of the knee for patients with medial plica syndrome. The investigators expect conservative treatment to be significantly superior to arthroscopic plica resection with regard to symptom remission and return to prior functional level.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged over 18 years
  • History of antermedial knee pain
  • Palpable medial band in clinical examination or medial plica appearence on MRI
  • Absence of all of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
  • Given declaration of consent
  • Joining a fitness centre for the duration of minimum 3 months at their own expense.

排除标准

  • Aged under 18 years
  • Presence of one or more of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
  • Prior surgical intervention, infection, fracture or patellar luxation concerning the relevant knee
  • Not willing to join a fitness centre for the duration of minimum 3 months at their own expense

结局指标

主要结局

Lysholm-Scale (Units on a scale)

时间窗: 2 years

Difference of minimum 5 points concerning the average scoring outcome on the Lysholm Knee Scoring Scala in favor of patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Units of measure (Units on a scale)

次要结局

  • QOL-Scale (Units on a scale)(2 years)
  • VAS-Scale (Visual Analog Scale for pain) (Units on a scale)(2 years)
  • Kujala-Scale (Units on a scale)(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steffen Sauer

Steffen Sauer, MD

Regionshospitalet Silkeborg

研究点 (4)

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