跳至主要内容
临床试验/NCT00816647
NCT00816647终止不适用

A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing

Finnish Defense Forces2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
50
试验地点
2
主要终点
Recurrent patellar instability

研究概览

简要总结

The operative management of chronic patellar instability has been controversial. Medial patellofemoral ligament reconstruction has gained success recently and might be superior to other soft-tissue procedures. The objective of this prospective study was to compare the clinical outcome after medial patellofemoral ligament reconstruction compared with medial reefing for chronic patellar instability.

详细描述

Many of the previous studies on medial patellofemoral ligament (MPFL) reconstruction for patellar instability have been difficult to interpret, either because the study setting has included both first-time and recurrent dislocations, or because a lack of control group. Moreover, several studies have enrolled patients with a wide age range, and the majority of the studies have employed retrospective and nonrandomized study designs. Therefore the investigators designed a prospective, randomized study with the primary goal to compare the outcome after MPFL reconstruction with medial reefing for chronic patellar instability. The distance between tibial tubercle and trochlear groove is measured on MRI and corrected if it exceeds 17mm. Primary outcome measure is the occurrence of recurrent objective and subjective patellar instability. The second goal is to evaluate the development of articular cartilage lesions within the patellofemoral joint, and assess clinical scores.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic patellar instability (more than 2 dislocations)
  • Minimum 6 months nonoperative treatment

排除标准

  • Severe PF OA
  • Acute patellar dislocation

结局指标

主要结局

Recurrent patellar instability

时间窗: 2 years

次要结局

  • Patellofemoral osteoarthrosis progression.(2 years)

研究者

发起方
Finnish Defense Forces
申办方类型
Other Gov

研究点 (2)

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