Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT02272218
Study Brief:
Protocol Section:
NCT02272218