ID

40800

Description

Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02272218

Link

https://clinicaltrials.gov/show/NCT02272218

Keywords

Versions (1)
  1. 5/15/20 5/15/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 15, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02272218

English

Eligibility Knee Osteoarthritis NCT02272218

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. able and willing to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. at least 25 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. body mass index (bmi) between 30 and 40 (fda-approved bmi window for lagb surgery if there is at least one comorbidity)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
4. pain in at least one knee for 15 of the 30 days prior to screening
Description

Pain Knee Quantity | Knee pain days per month

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0231749
UMLS CUI [2,2]
C0556971
1. clinically diagnosed with knee oa using american college of rheumatology (acr) criteria.
Description

Knee Osteoarthritis ACR Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3273747
2. patient pain visual analog scale (vas) ≥40
Description

Pain Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0042815
3. pain not controlled with tylenol, nsaids or topical therapy (or unable to use/tolerate nsaids for medical reasons)
Description

Pain Uncontrolled | Tylenol Absent | NSAIDs Absent | Therapy Topical Absent | Use of NSAIDs Unable | Intolerance to NSAIDs

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0699142
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0003211
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0332237
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C1524063
UMLS CUI [5,2]
C0003211
UMLS CUI [5,3]
C1299582
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0003211
5. anterior-posterior (ap) radiograph of at least one knee with kellgren-lawrence (k-l) grading scale ≥ 2 (moderate to severe osteoarthritis)
Description

Knee Quantity Radiography Anterior-Posterior | Knee Osteoarthritis Moderate Kellgren-Lawrence score | Knee Osteoarthritis Severe Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1,1]
C0022742
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0034571
UMLS CUI [1,4]
C1999039
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C3177117
UMLS CUI [3,1]
C0409959
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C3177117
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. unable to provide written informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
2. less than 25 yrs of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. bmi <30 or >40
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
4. does not fulfill the acr criteria for oa
Description

Lacking Fulfill Osteoarthritis Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0029408
UMLS CUI [1,4]
C0243161
5. vas <40
Description

Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1]
C0042815
6. any clinical disorder requiring use of corticosteroids within one week of visit
Description

Disease Requirement Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0001617
7. viscosupplementation or intra-articular steroid injection to the affected knee within the prior one month
Description

Viscosupplementation Knee Affected | Intraarticular steroid injection Knee Affected

Data type

boolean

Alias
UMLS CUI [1,1]
C2350507
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0392760
UMLS CUI [2,1]
C2064783
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C0392760
8. bilateral total knee replacement
Description

Total knee replacement Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C0238767
9. has not yet tried to treat pain with oral nsaids/cox-2 inhibitors (unless medical contraindications), tylenol, or topical therapy
Description

NSAIDs Oral Absent | Cox-2 Inhibitors Oral Absent | Exception Medical contraindication | Tylenol Absent | Therapy Topical Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1257954
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1301624
UMLS CUI [4,1]
C0699142
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1522168
UMLS CUI [5,3]
C0332197
10. co-morbidities including, congestive heart failure, hepatic or renal disease, chronic infectious diseases, non-cutaneous cancer within last five years
Description

Comorbidity | Congestive heart failure | Liver disease | Kidney Disease | Chronic infectious disease | Malignant Neoplasms | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0151317
UMLS CUI [6]
C0006826
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0699893
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)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1532765
UMLS CUI [1,3]
C1444657
UMLS CUI [2,1]
C0034072
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0014868
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0038358
UMLS CUI [5]
C0013295
UMLS CUI [6]
C0014867
UMLS CUI [7]
C0017145
UMLS CUI [8]
C0021390
UMLS CUI [9]
C0023890
UMLS CUI [10]
C0149521
UMLS CUI [11]
C0038580
UMLS CUI [12,1]
C0149783
UMLS CUI [12,2]
C0205191
UMLS CUI [13]
C0009450
12. anterior-posterior (ap) radiograph of both knees with k-l grade < 2
Description

Both knees Radiography Anterior-Posterior | Both knees Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1,1]
C0230434
UMLS CUI [1,2]
C0034571
UMLS CUI [1,3]
C1999039
UMLS CUI [2,1]
C0230434
UMLS CUI [2,2]
C3177117
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.
Description

Pregnancy | Childbearing Potential Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0240802
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Similar models

Eligibility Knee Osteoarthritis NCT02272218

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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