Informed Consent
Item
1. able and willing to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. at least 25 years of age
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
3. body mass index (bmi) between 30 and 40 (fda-approved bmi window for lagb surgery if there is at least one comorbidity)
boolean
C1305855 (UMLS CUI [1])
Pain Knee Quantity | Knee pain days per month
Item
4. pain in at least one knee for 15 of the 30 days prior to screening
boolean
C0030193 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231749 (UMLS CUI [2,1])
C0556971 (UMLS CUI [2,2])
Knee Osteoarthritis ACR Criteria
Item
1. clinically diagnosed with knee oa using american college of rheumatology (acr) criteria.
boolean
C0409959 (UMLS CUI [1,1])
C3273747 (UMLS CUI [1,2])
Pain Visual Analog Pain Scale
Item
2. patient pain visual analog scale (vas) ≥40
boolean
C0030193 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
Pain Uncontrolled | Tylenol Absent | NSAIDs Absent | Therapy Topical Absent | Use of NSAIDs Unable | Intolerance to NSAIDs
Item
3. pain not controlled with tylenol, nsaids or topical therapy (or unable to use/tolerate nsaids for medical reasons)
boolean
C0030193 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0699142 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0332237 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1524063 (UMLS CUI [5,1])
C0003211 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C1744706 (UMLS CUI [6,1])
C0003211 (UMLS CUI [6,2])
Knee Quantity Radiography Anterior-Posterior | Knee Osteoarthritis Moderate Kellgren-Lawrence score | Knee Osteoarthritis Severe Kellgren-Lawrence score
Item
5. anterior-posterior (ap) radiograph of at least one knee with kellgren-lawrence (k-l) grading scale ≥ 2 (moderate to severe osteoarthritis)
boolean
C0022742 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C1999039 (UMLS CUI [1,4])
C0409959 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3177117 (UMLS CUI [2,3])
C0409959 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C3177117 (UMLS CUI [3,3])
Informed Consent Unable
Item
1. unable to provide written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Age
Item
2. less than 25 yrs of age
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
3. bmi <30 or >40
boolean
C1305855 (UMLS CUI [1])
Lacking Fulfill Osteoarthritis Criteria
Item
4. does not fulfill the acr criteria for oa
boolean
C0332268 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Visual Analog Pain Scale
Item
5. vas <40
boolean
C0042815 (UMLS CUI [1])
Disease Requirement Adrenal Cortex Hormones
Item
6. any clinical disorder requiring use of corticosteroids within one week of visit
boolean
C0012634 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
Viscosupplementation Knee Affected | Intraarticular steroid injection Knee Affected
Item
7. viscosupplementation or intra-articular steroid injection to the affected knee within the prior one month
boolean
C2350507 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C2064783 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
Total knee replacement Bilateral
Item
8. bilateral total knee replacement
boolean
C0086511 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
NSAIDs Oral Absent | Cox-2 Inhibitors Oral Absent | Exception Medical contraindication | Tylenol Absent | Therapy Topical Absent
Item
9. has not yet tried to treat pain with oral nsaids/cox-2 inhibitors (unless medical contraindications), tylenol, or topical therapy
boolean
C0003211 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1257954 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C0699142 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C1522168 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Comorbidity | Congestive heart failure | Liver disease | Kidney Disease | Chronic infectious disease | Malignant Neoplasms | Exception Skin carcinoma
Item
10. co-morbidities including, congestive heart failure, hepatic or renal disease, chronic infectious diseases, non-cutaneous cancer within last five years
boolean
C0009488 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0151317 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0699893 (UMLS CUI [7,2])
Comorbidity Laparoscopic adjustable gastric banding Contraindicated | Cardiopulmonary disease Severe | Esophagitis Severe | Gastric ulcer | Duodenal Ulcer | Esophageal Varices | Gastric Varix | Inflammatory Bowel Disease | Liver Cirrhosis | Pancreatitis, Chronic | Substance Dependence | Steroid therapy chronic | Communicable Diseases
Item
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)
boolean
C0009488 (UMLS CUI [1,1])
C1532765 (UMLS CUI [1,2])
C1444657 (UMLS CUI [1,3])
C0034072 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0014868 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0038358 (UMLS CUI [4])
C0013295 (UMLS CUI [5])
C0014867 (UMLS CUI [6])
C0017145 (UMLS CUI [7])
C0021390 (UMLS CUI [8])
C0023890 (UMLS CUI [9])
C0149521 (UMLS CUI [10])
C0038580 (UMLS CUI [11])
C0149783 (UMLS CUI [12,1])
C0205191 (UMLS CUI [12,2])
C0009450 (UMLS CUI [13])
Both knees Radiography Anterior-Posterior | Both knees Kellgren-Lawrence score
Item
12. anterior-posterior (ap) radiograph of both knees with k-l grade < 2
boolean
C0230434 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1999039 (UMLS CUI [1,3])
C0230434 (UMLS CUI [2,1])
C3177117 (UMLS CUI [2,2])
Pregnancy | Childbearing Potential Pregnancy test positive
Item
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.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0240802 (UMLS CUI [2,2])