Knee Osteoarthritis Clinical Trial
Official title:
The Effects of Bariatric Surgery Weight Loss on Knee Pain in Patients With Osteoarthritis of the Knee
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
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04651673 -
Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
|
||
Completed |
NCT05677399 -
Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.
|
N/A | |
Active, not recruiting |
NCT04043819 -
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
|
Phase 1 | |
Recruiting |
NCT06000410 -
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
|
Phase 3 | |
Completed |
NCT05014542 -
Needling Techniques for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05892133 -
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT05528965 -
Parallel Versus Perpendicular Technique for Genicular Radiofrequency
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Active, not recruiting |
NCT02003976 -
A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
|
N/A | |
Active, not recruiting |
NCT04017533 -
Stability of Uncemented Medially Stabilized TKA
|
N/A | |
Completed |
NCT04779164 -
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT04006314 -
Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05423587 -
Genicular Artery Embolisation for Knee Osteoarthritis II
|
N/A | |
Enrolling by invitation |
NCT04145401 -
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
|
||
Active, not recruiting |
NCT03781843 -
Effects of Genicular Nerve Block in Knee Osteoarthritis
|
N/A | |
Completed |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
Completed |
NCT05324163 -
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
|
Phase 3 | |
Completed |
NCT05529914 -
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05693493 -
Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?
|
N/A | |
Not yet recruiting |
NCT05510648 -
Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
|
N/A |