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临床试验/NCT01375231
NCT01375231已完成4 期

Anatomic Reconstruction of the Patellofemoral Joint: A Solution for Anterior Knee Pain

OrthoCarolina Research Institute, Inc.2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
52
试验地点
2
主要终点
Anterior knee Pain

研究概览

简要总结

The investigators posit that it would be advantageous to reproduce the height of the entire patellofemoral joint in order to maintain the lever arm of the quadriceps mechanism at its preoperative level. Failure to do this may cause the quadriceps mechanism to be inefficient. For example the quadriceps mechanism would have to work harder if the total patellofemoral (PF) height is diminished. Alternatively, diminished motion or increased patellar strain may occur if the overall PF height is increased. The investigators theorize that either of these sizing errors could lead to anterior knee pain. The purpose of this study is to compare the clinical outcomes between two surgical techniques: 1) a technique of reproducing the total PF joint on both sides of the articulation (Group 1) and 2) the traditional technique of reproducing only the patellar thickness on one side of the joint (Group 2).

详细描述

There is no consensus on the source of the anterior pain or the most efficacious treatment. Multiple etiologies have been theorized concerning the cause of this problem including tibiofemoral instability, patellofemoral (PF) instability, PF maltracking and patella stress fractures. It has been reported that patellofemoral forces are associated with anterior knee pain. Moreover, it has been reported that a correlation exists between the tension of the quadriceps muscle and the forces on the patella. In a biomechanical, cadaver study, Browne et al. found that a longer extensor moment arm reduced the tension on the quadriceps and reduced the patellar forces.

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

性别
All
接受健康志愿者

入选标准

  • Patients presenting for a primary total knee replacement who have failed conservative medical management.
  • Total knee replacement includes patella resurfacing.
  • Patient is willing and able to understand, sign, and date the study specific patient informed consent, to volunteer participation in the study.
  • Patient is psychosocially, mentally, and physically able to comply with the requirements of the study including post-op clinical evaluations and completion of questionnaires.

排除标准

  • Patients presenting for a unicompartmental knee replacement.
  • Patients presenting for a revision total knee replacement.
  • Total knee replacement does not include patella resurfacing.
  • Patients with angular deformity greater than 15 degrees.
  • Patients with subluxation/dislocation of the patella.
  • Patients with severe patellar bone loss.

结局指标

主要结局

Anterior knee Pain

时间窗: 1 year postoperatively

Measured by visual analog scale

次要结局

  • Range of Motion of knee(1 year postoperative)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS)(1 year postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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