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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kevin P. Black, Penn State University
ClinicalTrials.gov Identifier:
NCT00752765
First received: September 11, 2008
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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


Condition
Knee Pain
Knee Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effects of Bariatric Surgery Weight Loss on Knee Pain in Patients With Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Outcome measures will be determined with the WOMAC and KOOS surveys. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study will be looking at obese patients with co-morbidity of knee osteoarthritis.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients will be ineligible for the study if any of these criteria are not met.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752765

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17070
Sponsors and Collaborators
Penn State University
Investigators
Study Director: Ann M. Rogers, M.D. Penn State Milton S. Hershey Medical Center, Dept of Surgery
  More Information

Publications:
Responsible Party: Kevin P. Black, Professor and Chair, Orthopaedics and Rehabilitation, Penn State University
ClinicalTrials.gov Identifier: NCT00752765     History of Changes
Other Study ID Numbers: 28727
Study First Received: September 11, 2008
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
knee osteoarthritis
bariatric surgery
weight loss
knee pain

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Weight Loss
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014