跳至主要内容
临床试验/NCT05868434
NCT05868434招募中不适用

Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.

Artromedical Konrad Malinowski Clinic2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年2月25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
15
试验地点
2
主要终点
Lateral patella stability - apprehension test

研究概览

简要总结

The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.

详细描述

Medial Patellofemoral Ligament (MPFL) injury occurs in more than 95% of lateral patellar dislocations. Most of these injuries result in subsequent lateral patellar instability. Therefore, MPFL reconstruction (MPFLR) is often necessary. The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.

The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lateral patellar dislocation with subsequent instability
  • Failure of non-operative treatment

排除标准

  • Active inflammation of the knee;
  • Previous surgeries on the patellofemoral joint;
  • Fractures around the knee

结局指标

主要结局

Lateral patella stability - apprehension test

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

Apprehension test at 30 degrees of knee flexion

Lateral patella stability - lateral luxation test

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

Lateral luxation test at 30 degrees of knee flexion

次要结局

  • ROM(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.)
  • The functional assessment with the Knee injury and Osteoarthritis Outcome Score(At the 24 month of the follow-up.)

研究者

发起方
Artromedical Konrad Malinowski Clinic
申办方类型
Other
责任方
Principal 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 (2)

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