Status:
COMPLETED
Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis
Lead Sponsor:
NYU Langone Health
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
25+ years
Phase:
NA
Brief Summary
The primary purpose of this study is to evaluate laparoscopic gastric banding (LAGB) surgery as a treatment option for obese patients with pain from knee osteoarthritis (KOA) refractory to medical tre...
Detailed Description
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 musculoskelet...
Eligibility Criteria
Inclusion
- able and willing to provide written informed consent
- at least 25 years of age
- body mass index (BMI) between 30 and 40 (FDA-approved BMI window for LAGB surgery if there is at least one comorbidity)
- pain in at least one knee for 15 of the 30 days prior to screening
- clinically diagnosed with knee OA using American College of Rheumatology (ACR) criteria.
- Patient pain visual analog scale (VAS) ≥40
- pain not controlled with Tylenol, NSAIDs or topical therapy (or unable to use/tolerate NSAIDs for medical reasons)
- anterior-posterior (AP) radiograph of at least one knee with Kellgren-Lawrence (K-L) grading scale ≥ 2 (moderate to severe osteoarthritis)
Exclusion
- unable to provide written informed consent
- less than 25 yrs of age
- BMI \<30 or \>40
- does not fulfill the ACR criteria for OA
- VAS \<40
- any clinical disorder requiring use of corticosteroids within one week of visit
- viscosupplementation or intra-articular steroid injection to the affected knee within the prior one month
- bilateral total knee replacement
- has not yet tried to treat pain with oral NSAIDs/COX-2 inhibitors (unless medical contraindications), Tylenol, or topical therapy
- co-morbidities including, congestive heart failure, hepatic or renal disease, chronic infectious diseases, non-cutaneous cancer within last five years
- comorbidities that would make lap band surgery contraindicated (severe cardiopulmonary diseases, severe esophagitis, stomach or duodenal ulcers, esophageal or gastric varices, inflammatory bowel disease, liver cirrhosis, chronic pancreatitis, alcohol or drug addiction, on chronic steroid treatment, or active infections)
- anterior-posterior (AP) radiograph of both knees with K-L grade \< 2
- pregnancy or women of childbearing potential with a positive pregnancy test during pre-surgical phases of the study as part of standard of care pre-op testing.
Key Trial Info
Start Date :
October 23 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02272218
Start Date
October 23 2012
End Date
October 18 2018
Last Update
February 11 2020
Active Locations (1)
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1
Center for Musculoskeletal Care
New York, New York, United States, 10016