Clinical trial: Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis (NCT02272218)

Eligibility criteria:
Inclusion Criteria:

          1. able and willing to provide written informed consent

          2. at least 25 years of age

          3. body mass index (BMI) between 30 and 40 (FDA-approved BMI window for LAGB surgery if
             there is at least one comorbidity)

          4. pain in at least one knee for 15 of the 30 days prior to screening

               1. clinically diagnosed with knee OA using American College of Rheumatology (ACR)
                  criteria.

               2. Patient pain visual analog scale (VAS) ≥40

               3. pain not controlled with Tylenol, NSAIDs or topical therapy (or unable to
                  use/tolerate NSAIDs for medical reasons)

          5. anterior-posterior (AP) radiograph of at least one knee with Kellgren-Lawrence (K-L)
             grading scale ≥ 2 (moderate to severe osteoarthritis)

        Exclusion Criteria:

          1. unable to provide written informed consent

          2. less than 25 yrs of age

          3. BMI <30 or >40

          4. does not fulfill the ACR criteria for OA

          5. VAS <40

          6. any clinical disorder requiring use of corticosteroids within one week of visit

          7. viscosupplementation or intra-articular steroid injection to the affected knee within
             the prior one month

          8. bilateral total knee replacement

          9. has not yet tried to treat pain with oral NSAIDs/COX-2 inhibitors (unless medical
             contraindications), Tylenol, or topical therapy

         10. co-morbidities including, congestive heart failure, hepatic or renal disease, chronic
             infectious diseases, non-cutaneous cancer within last five years

         11. 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)

         12. anterior-posterior (AP) radiograph of both knees with K-L grade < 2

         13. 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? 1