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临床试验/NCT01965886
NCT01965886Unknown不适用

Medial vs Lateral Approach for Total Knee Replacement on Valgus Knee: Prospective and Randomized Clinical Trial

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
126
试验地点
2
主要终点
Knee Score

研究概览

简要总结

The most common surgical approach to perform a total knee replacement is called medial parapatellar approach. It's effective and can be applied virtually to all types of knee deformities. The Keblish approach is an alternative approach which uses the lateral side of the patella to enter the joint. Some orthopaedic surgeons consider the latter approach a better option when facing a valgus deformity of the osteoarthritic knee but there is no convincing evidence on the literature supporting one or another approach. The objective of this study is to compare the medial vs lateral approach for total knee replacement on valgus knee.

详细描述

Total knee replacement is a procedure for the treatment of advanced knee osteoarthritis. The most common surgical approach to perform a total knee replacement is called medial parapatellar approach, or simply medial approach. It's effective and can be applied virtually to all types of knee deformities. The Keblish approach is an alternative approach which uses the lateral side of the patella to enter the joint. It's also called lateral parapatellar approach. Some orthopaedic surgeons consider the latter approach a better option when facing a valgus deformity of the osteoarthritic knee. Theoretically, the Keblish approach can promote better soft tissue balance and patellar tracking, but there is no convincing evidence on the literature supporting one or another approach for a total knee replacement on valgus knee. The objective of this prospective and randomized clinical trial is to compare the medial vs lateral approach for total knee replacement on valgus knee.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Severe osteoarthritis (Kellgren & Lawrence grade 4)
  • Valgus deformity of the knee
  • Read and sign the informed consent form

排除标准

  • Severe pain in other joint (VAS>6)
  • Comorbidities or any condition that contraindicate the procedure
  • Previous arthroplasty on the index knee

结局指标

主要结局

Knee Score

时间窗: 1 year

Evaluation of patient's pain and function using the Knee Society questionnaire

次要结局

  • VAS(2 years)
  • WOMAC(2 years)
  • Knee alignment(6 months)
  • Hemoglobin(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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