Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02272218|
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Procedure: bariatric lap band surgery||Not Applicable|
This is a pilot study of 15 (may need to consent/screen 30 patients to have 15 enrolled) obese patients (BMI 30-40) with painful knee osteoarthritis. Although prior studies have reported musculoskeletal secondary outcomes following various types of bariatric surgery, investigators propose the evaluation of laparoscopic gastric banding (LAGB) to treat a cohort of patients with moderate to severe knee osteoarthritis.
Once eligible patients are identified by rheumatologists and/or bariatric team and consented for the study, they will have bilateral knee radiographs (standard of care) to ensure they have a sufficient degree of OA. Patients will then be referred to the bariatric surgeons, who will then confirm the patients' interest, understanding and suitability for the LAGB surgery which is a FDA approved procedurefor patients with a BMI >30 and at least one obesity-related comorbidity (including knee OA)37. It is the application of this approved procedure that constitutes the research question should LAGB surgery be considered as a treatment option to improve pain and physical disability in patients with knee OA? During the pre-operative process patients will be given study questionnaires to evaluate knee pain and function, have a musculoskeletal exam and blood/urine will be collected.These procedures will be repeated at post-operative intervals to track response of the knees to the LAGB.
The primary outcome measure is improvement in OA-related knee pain and physical disability. Improvement of pain and function will be defined by changes in the VAS, WOMAC, AORC and KOOS scores. The degree of improvement required to qualify as such will be described in the methods sections below.
Secondary outcome measures include (1) radiographic evidence of OA progression or worsening despite the LABG, (2) weight loss, and (3) reduction or discontinuation of pain medication.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis|
|Actual Study Start Date :||October 23, 2012|
|Actual Primary Completion Date :||October 18, 2018|
|Actual Study Completion Date :||October 18, 2018|
There is only one arm for this study, since this study involves a single cohort receiving the same intervention, laparoscopic gastric banding (LAGB) surgery.
Procedure: bariatric lap band surgery
The intervention in this study is laparoscopic gastric banding (LAGB) surgery as a treatment option for obese patients with pain from knee osteoarthritis (KOA) refractory to medical treatment
- reduction in OA-related pain and disability after LAGB. [ Time Frame: 4 years ]questionnaires will be distributed pre- and post-surgery.
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): NCT02272218
|United States, New York|
|Center for Musculoskeletal Care|
|New York, New York, United States, 10016|