The Effects of Bariatric Surgery Weight Loss on Knee Pain in Patients With Osteoarthritis of the Knee
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|ClinicalTrials.gov Identifier: NCT00752765|
Recruitment Status : Completed
First Posted : September 15, 2008
Last Update Posted : June 3, 2015
|Condition or disease|
|Knee Pain Knee Osteoarthritis|
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.
In this study we will be examining the effect of weight loss through bariatric surgery on Knee pain in patients with clinical criteria indicative of osteoarthritis.
Our main objective is to determine if weight loss from bariatric surgery contributes to relief of knee pain and increased function in patients with osteoarthritis.
The study will be looking at obese patients with co-morbidity of knee osteoarthritis.
An interview will be administered and if appropriate, potential candidates will be asked a series of questions taken from the pain section of the Western Ontario McMaster Universities Index of Osteoarthritis (WOMAC). Patients with a WOMAC pain score ≥ 3 will then be asked to have a series of X-rays taken of their knees. Those individuals who display radiographic evidence of knee OA will be asked to participate in the study until the twenty five positions are filled. At their next pre-bariatric surgery visit, the study participants will have a basic knee exam performed by Kevin P. Black, M.D. in order to evaluate the structural integrity and alignment of the knee joint. The information gathered from the exam will serve as a baseline measure of knee function for the study. Prior to undergoing surgery, each of the 25 patients will be asked to complete a full version of the WOMAC survey and a separate, related survey the Knee and Osteoarthritis Outcome Score (KOOS). These surveys will be re-administered at 6, 12, and 24 months post-surgery in order to assess any changes in knee pain and function.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||The Effects of Bariatric Surgery Weight Loss on Knee Pain in Patients With Osteoarthritis of the Knee|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
- Outcome measures will be determined with the WOMAC and KOOS surveys. [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752765
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17070|
|Study Director:||Ann M. Rogers, M.D.||Penn State Milton S. Hershey Medical Center, Dept of Surgery|