跳至主要内容
临床试验/NCT00752765
NCT00752765已完成不适用

The Effects of Bariatric Surgery Weight Loss on Knee Pain in Patients With Osteoarthritis of the Knee

Penn State University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Outcome measures will be determined with the WOMAC and KOOS surveys.

研究概览

简要总结

This project is a prospective observational study that will involve the participation of 25 volunteers that qualify for having knee osteoarthritis, are going to be having gastric bypass surgery and are willing to participate in this study which is designed to last up to two years. Potential candidates will be interviewed using a standard set of questions related to the study

详细描述

Osteoarthritis (OA) of the knee is one of the five leading causes of disability among elderly men and women1. According to the American Academy of Orthopedic Surgeons, an estimated 19 million visits are made each year to physician's offices due to knee-related problems, while the total cost of OA was estimated at $60 billion in 2004.2

Obesity is a primary risk factor for the development of OA among several other features such as age, gender, trauma, infection, heredity, and high impact sports. In the United States, obesity has reached epidemic proportions and experiments have shown that individuals clinically defined as obese with a BMI > 30.0 kg/m2 are four times more likely to have knee OA than those with a BMI < 25.0 kg/m2(3).

The most common non-surgical treatment for knee OA has been the use of non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by inhibiting the cyclooxygenase (COX) enzymes involved in the production of pro-inflammatory molecules in the body. Although the use of these drugs has been shown to temporarily relieve pain and swelling associated with OA, there are several negative side-effects related to NSAID use including health concerns and cost.

If chronic NSAID use for knee pain can be reduced, that would be an exceptional public health benefit and would decrease cost and related hospital admissions and deaths.

This study investigates a non-surgical approach to the relief of pain associated with osteoarthritis in an attempt to offer a safer, less expensive alternative to other treatments.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be included in the study, patients must be between the 18 and 70 years of age
  • Completed a pre-surgery psychological evaluation, and have had intermittent knee pain for at least a year.
  • The bariatric surgery requirement involves a bypass of the stomach.
  • Standard of care guidelines for this surgery require that these patients' previous dieting attempts were without success
  • Medical problems related to obesity, such as diabetes, sleep apnea, hypoventilation, and joint pain.
  • Patients will have a WOMAC pain scale score > 3, according to the study by Miller, et al.
  • Patients will have a standing AP, lateral and Merchant radiographic scan taken to confirm that they have OA.

排除标准

  • Patients will be ineligible for the study if any of these criteria are not met.

结局指标

主要结局

Outcome measures will be determined with the WOMAC and KOOS surveys.

时间窗: 24 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin P. Black

Professor and Chair, Orthopaedics and Rehabilitation

Penn State University

研究点 (1)

Loading locations...

相似试验