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临床试验/NCT00991588
NCT00991588已完成不适用

Reconstruction of the Posterior Cruciate Ligament and Posterolateral Structures of the Knee

Sue Barber-Westin1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Elimination of knee giving-way

研究概览

简要总结

The purpose of this investigation is to determine the clinical outcome of surgical reconstruction of complete ruptures to the posterior cruciate ligament (PCL) and posterolateral structures of the knee joint. The outcome will be determined with validated and rigorous knee rating systems between 2 and 10 years postoperatively. The results will be determined by the analysis of subjective and functional factors, sports and occupational activity levels, a comprehensive physical examination, and a radiographic evaluation. We hypothesize that the appropriately indicated procedures will effectively restore normal knee stability and function in patients with isolated or combined injuries to these structures.

详细描述

Because injuries to the PCL and posterolateral structures occur with less frequency than other structures in the knee joint (such as the anterior cruciate ligament and menisci), fewer studies are available to assist the surgeon and patient with appropriate decision-making regarding conservative versus surgical treatment. The majority of patients who sustain injury to these structures are treated conservatively. Unfortunately, several investigations describe noteworthy symptoms and functional limitations following conservative management, and a high percentage of patients develop knee osteoarthritis that can be disabling for both recreational and daily activities. The investigators of this study have nearly three decades of experience and have extensively studied the effects of this injury in both the laboratory and clinic settings. It is our opinion that surgical reconstruction provides significant benefit when appropriately indicated, as has been demonstrated in our previous studies. Especially in athletic individuals, PCL and posterolateral reconstructive procedures have advanced to the point where more predictable results can be expected to restore sufficient knee function. Studies have demonstrated, at least in the short-term, that the majority of patients with acute ligament ruptures treated with reconstruction are able to return to various levels of sports activities.12 Whether these procedures will decrease the risk of the patient developing future osteoarthritis is unknown and requires further study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Complete rupture to the posterior cruciate ligament, greater than 10 mm of increased posterior tibial translation
  • Rupture to the posterolateral knee structures, greater than 5 mm of increased lateral tibiofemoral joint opening, greater than 10 degrees of increased external tibial rotation
  • Patient willing to comply with postoperative rehabilitation program

排除标准

  • Patient unwilling to participate

结局指标

主要结局

Elimination of knee giving-way

时间窗: Minimum 2 years postoperatively

次要结局

  • Posterior tibial translation(Minimum 2 years postoperative)
  • Lateral tibiofemoral joint opening(Minimum 2 years postoperatively)
  • External tibial rotation(Minimum 2 years postoperatively)
  • Elimination of knee pain(Minimum 2 years postoperatively)

研究者

发起方
Sue Barber-Westin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sue Barber-Westin

Director Clinical Studies

Cincinnati Sportsmedicine Research and Education Foundation

研究点 (1)

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