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临床试验/NCT01132365
NCT01132365Unknown不适用

Knee Arthroplasty Registry a. Function and Survival Stratified by BMI b. Return of Quadriceps Strength After Primary TKA

Heekin Orthopedic Research Institute1 个研究点 分布在 1 个国家目标入组 7,793 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
7,793
试验地点
1
主要终点
Knee Society Score

研究概览

简要总结

Objective

Describe the clinical and demographic characteristics of patients who undergo knee arthroplasty and document post operative outcomes.

Examine the relationship between processes of care, hospital and surgeon associated outcomes.

Provide expanded data to characterize existing and evolving practice patterns, delivery of care, and resource utilization in the management of knee arthroplasty patients.

Analyze and design ancillary studies to address unanswered questions.

Disseminate findings through publication in peer-reviewed scientific journals.

详细描述

Population: All male and non-pregnant females undergoing knee arthroplasty.

Study Design: Prospective, consecutive series on an unlimited number of patients.

Data Collection

Clinic Data:

Patient Demographics- age, weight, height, gender, affected side, co-morbidities, current medications, and contact information Knee Society Score SF-12 Evaluation of radiographs- AP, ML, and merchant view Preop lab results

研究设计

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

入排标准

年龄范围
21 Years 至 93 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is a male or non-pregnant female over the age of
  • Patient requires a knee arthroplasty, revision knee arthroplasty, or unicondylar knee arthroplasty
  • Patient has signed and dated an IRB approved consent form.
  • Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions.
  • Patient has failed to respond to conservative treatment modalities.

排除标准

  • Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
  • Patient is a prisoner.

结局指标

主要结局

Knee Society Score

时间窗: 2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years

次要结局

未报告次要终点

研究者

发起方
Heekin Orthopedic Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

R. David Heekin, MD

R. David Heekin, M.D.

Heekin Orthopedic Research Institute

研究点 (1)

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