跳至主要内容
临床试验/NCT06257836
NCT06257836进行中(未招募)不适用

Medial Patellofemoral Ligament Reconstruction in Children - a 2-8 Years Follow-up Study

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
160
试验地点
1
主要终点
Kujala (Anterior Knee Pain Scale)

研究概览

简要总结

The purpose of this project is to investigate the treatment outcome after MPFL reconstruction in children as a treatment for chronic patellar instability, where the superficial part of the quadriceps tendon is fixed to the femur with anchors.

The outcome will be compared with a healthy cohort matched on age and gender.

详细描述

Lateral patella dislocation (PL) is defined as a total dislocation of the patella out of the trochlea.

In chronic patella instability, where the patella has been repeatedly dislocated, the treatment is most often surgical. The main ligamentous structure that stabilizes the patella against lateralization is the medial patello-femoral ligament (MPFL). The MPFL is a centimeter-thin ligamentous structure that runs from the upper medial patellar border to the medial femoral epicondyle. This ligament is torn in more than 90% of cases of PL and healing of the ligament is often insufficient, especially if there are predisposing factors in the knee joint such as dysplasia of the patello-femoral joint, high standing patella (patella alta) and hypermobility.

MPFL reconstruction (MPFL-r) can be performed with many different surgical techniques, but the basic principle is to use autologous tendon tissue to create a new MPFL by anchoring the new tendon tissue to the medial patellar border and the medial femoral epicondyle, while ensuring isometry of the reconstruction.

A number of different methods have been described for anchoring the new MPFL to the patella and femoral condyle.

The most commonly used type of graft for MPFL-r is the gracilis tendon, which is fixed with screws in the femur bone preceded by drilling a channel in the femoral condyle.

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
14 Years 至 23 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Kujala (Anterior Knee Pain Scale)

时间窗: 24 month

Patient reported outcome score, 0=worst and 100=best

次要结局

  • One-legged single hop for distance(24 month)
  • Donor site morbidity score, 0=worst and 100=best(24 month)
  • Numerical Rating Scale (NRS-pain score)(24 month)
  • Tegner (Activity Score)(24 month)
  • Knee pain(24 month)
  • One-legged triple hop for distance(24 month)
  • Side-to-side hop test(24 month)
  • Gluteus Medius Strength test(24 month)
  • Quadriceps Strength test(24 month)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Lind

Professor, PhD, MD

Aarhus University Hospital

研究点 (1)

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