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临床试验/NCT02263807
NCT02263807已完成不适用

RCT Study:Knee Function in Patients With Two or More Episodes of Patella Dislocations

Asbjorn Aroen2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2010年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
2
主要终点
Reoperation

研究概览

简要总结

Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included into a randomized prospective study. This study comparess the outcome of two forms of treatment for recurrent patella dislocation. One group is offered reconstruction of the medial patellofemoral ligament (MPFL), the second group is offered a standardized training program.

详细描述

Introduction:

Patella dislocation is a serious knee injury whose peak incidence occurs in patients aged 10-17 years and is associated with a high rate of re-dislocation. Knee injuries frequently cause long-term disability and reduced physical activity among adolescents and young persons. Surgery in this patient group requires a low tolerance for complications, meaning that physical therapy might offer more successful outcomes in many knee injury cases. The proposed project studies a particular patient cohort subjected to recurrent dislocation of the patella.

Aim:

The principal objective of this clinical, randomized controlled trial is to evaluate and compare knee function and symptoms in patients with recurrent patella dislocation randomized into treatment with surgical reconstruction of the medial patellofemoral ligament (MPFL) with those of patients in a standardized physiotherapy program designed to stabilize the patella and improve patient function.

Materials and methods:

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
12 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •More than one luxation
  • •Norwegian citizens
  • •Unilateral problems
  • •Age range 12-30 years

排除标准

  • •Generalized degenerative changes

研究组 & 干预措施

MPFL group

Experimental

Arthroscopy and MPFL reconstruction

干预措施: MPFL Group (Procedure)

MPFL group

Experimental

Arthroscopy and MPFL reconstruction

干预措施: Control (Procedure)

Control

Active Comparator

Arhroscopy and rehabilitation

干预措施: Control (Procedure)

结局指标

主要结局

Reoperation

时间窗: 2011-2022

Numbers of reoperation in the two treatment groups

次要结局

  • Patella reluxation(2011-2022)

研究者

发起方
Asbjorn Aroen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Asbjorn Aroen

Professor, Orthopaedic Surgeon

University Hospital, Akershus

研究点 (2)

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