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临床试验/NCT05701592
NCT05701592招募中不适用

Assessment of Outcomes of Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR)

Konrad Malinowski MD1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
Knee posterior translatory stability - stress X-ray

研究概览

简要总结

Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR) is becoming increasingly used alternative to the single-bungle PCLR. While more technically challenging, it seems to better improve patients' outcomes. Therefore, outcomes of DB-PCLR will be assessed and reported.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • PCL tear with III grade sympomatic posterior instability confirmed clinically and radiologically
  • full knee range of motion

排除标准

  • active knee inflammation
  • non-adherence to the study protocol
  • fixed posterior drawer

结局指标

主要结局

Knee posterior translatory stability - stress X-ray

时间窗: At the 24 month of the follow-up.

Stress X-ray assessing posterior translatory stability of the knee will be performed and outcomes will be presented in milimeters

Knee posterior translatory stability - posterior Lachman test

时间窗: At the 24 month of the follow-up.

Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters

Knee posterior translatory stability - posterior sag test

时间窗: At the 24 month of the follow-up.

Posterior sag test will be performed and outcome will be presented as present/ absent

Knee posterior translatory stability - posterior drawer test

时间窗: At the 24 month of the follow-up.

Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters

Knee internal rotation stability

时间窗: At the 24 month of the follow-up.

Maximal knee internal rotation angle will be assessed with different angles of knee flexion and measured by the means of goniometer and outcomes will be presented in degrees

次要结局

  • The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)(At the 24 month of the follow-up.)
  • Retear rate(At the 24 month of the follow-up.)
  • The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)(At the 24 month of the follow-up.)
  • ROM(At the 24 month of the follow-up.)

研究者

发起方
Konrad Malinowski MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Konrad Malinowski MD

Konrad Malinowski MD, Director of Artromedical Konrad Malinowski Clinic and Principal Investigator

Artromedical Konrad Malinowski Clinic

研究点 (1)

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