跳至主要内容
临床试验/NCT05184439
NCT05184439已完成不适用

Clinical, Radiological and Isokinetic Evaluation of Adductor Magnus Tenodesis in Patients With Recurrent Patellar Dislocation.

Polish Mother Memorial Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Apprehension test

研究概览

简要总结

Between 2010 and 2012, 33 children and adolescents (39 knees) with recurrent patellar dislocation were treated with MPFL reconstruction using the adductor magnus tendon.The aim of the study is to assess the effectiveness of this surgical procedure in long follow-up. The outcomes will be evaluated functionally (Lysholm knee scale, the Kujala Anterior Knee Pain Scale, and isokinetic examination) and radiographically (Caton-Deschamps index, sulcus angle, congruence angle, and patellofemoral angle). This is a continuation of the research published in 2015 with longer follow-up at least 10 years. All available patients will be evaluated with the same protocol, using the same methods and devices. Functional outcome is planned to be measured with scales as above. In radiological assessment Merchant and lateral knee weight bearing view and additionally MRI will be performed. Isokinetic test will be performed in two speeds of 60 and 180 deg/s. Most of important isokinetic parameters such as peak torque, torque in 30 deg, time to peak torque, peak torque to body weight both for quadriceps and hamstrings will be measured and compared to those from former research. Dedicated statistical test will be used for both: analysis of present status and differences from former results.

详细描述

Recurrent dislocation of the patella is a common orthopaedic problem which occurs in about 44% of cases after first-time dislocation. In most cases of first-time patellar dislocation, the medial patellofemoral ligament (MPFL) becomes damaged. Between 2010 and 2012, 33 children and adolescents (39 knees) with recurrent patellar dislocation were treated with MPFL reconstruction using the adductor magnus tendon. The aim of the study is to assess the effectiveness of this surgical procedure in long follow-up. The outcomes will be evaluated functionally (Lysholm knee scale, the Kujala Anterior Knee Pain Scale, and isokinetic examination) and radiographically (Caton-Deschamps index, sulcus angle, congruence angle, and patellofemoral angle). This is a continuation of the research published in 2015 with longer follow-up at least 10 years. All available patients will be evaluated with the same protocol, using the same methods and devices. Functional outcome is planned to be measured with scales as above. In radiological assessment Merchant and lateral knee weight bearing view and additionally MRI will be performed. Isokinetic test will be performed in two speeds of 60 and 180 deg/s. Most of important isokinetic parameters such as peak torque, torque in 30 deg, time to peak torque, peak torque to body weight both for quadriceps and hamstrings will be measured and compared to those from former research. Dedicated statistical test will be used for both: analysis of present status and differences from former results.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
15 Years 至 27 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patellar dislocation that had occurred at least twice,
  • positive apprehensive test,
  • completed research protocol
  • age under 18 years at the time of surgery (adductor magnus tenodesis according to Avikainen)

排除标准

  • first-time patellar dislocation
  • habitual patellar dislocation
  • patients with osteochondral fracture

结局指标

主要结局

Apprehension test

时间窗: up to six months

Fear during patellar passive lateralisation

Lysholm Score

时间窗: up to six months

Subjective outcome evaluation scale

Kujala Score

时间窗: up to six months

Subjective outcome evaluation scale

Sulcus angle

时间窗: up to six months

Index describing trochlear shape

Congruence angle

时间窗: up to six months

Index describing patellar shift

Patellofemoral angle

时间窗: up to six months

Index describing patellar tilt

Caton-Deschamps index

时间窗: up to six months

Index describing patellar height

Peak torque

时间窗: up to six months

Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - Newton-Metre (Nm)

Torque in 30 deg

时间窗: up to six months

Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - Newton-Metre (Nm)

Time to peak torque

时间窗: up to six months

Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - seconds (s)

Peak torque to body weight

时间窗: up to six months

Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - Nm/kg

次要结局

未报告次要终点

研究者

发起方
Polish Mother Memorial Hospital Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验