ID

40788

Description

Ketorolac Versus Triamcinolone Knee Injections for Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02295189

Link

https://clinicaltrials.gov/show/NCT02295189

Keywords

Versions (1)
  1. 5/13/20 5/13/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 13, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02295189

English

Eligibility Knee Osteoarthritis NCT02295189

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject must be at least 18 years of age and no older than 90 years of age; of either gender
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
radiographic evidence of symptomatic osteoarthritis in one or bilateral knees. osteoarthritis will be defined as pain with weight-bearing at the tibiofemoral and/or patellofemoral articulation together with radiographic findings as described below.
Description

Unilateral primary osteoarthritis of knee Symptomatic | Bilateral primary osteoarthritis of knee Symptomatic | Pain Femorotibial joint | Pain Patellofemoral joint

Data type

boolean

Alias
UMLS CUI [1,1]
C2893932
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C2893930
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0030193
UMLS CUI [3,2]
C0447795
UMLS CUI [4,1]
C0030193
UMLS CUI [4,2]
C0447801
at the painful articulation, radiographic evidence of kellgren-lawrence
Description

Arthralgia Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1,1]
C0003862
UMLS CUI [1,2]
C3177117
grade 2: definite osteophytes and possible narrowing of joint cartilage associated with sclerosis of subchondral bone or,
Description

Kellgren-Lawrence score Grade | Osteophytes | Articular cartilage Narrowing | Sclerosis of subchondral bone of joint

Data type

boolean

Alias
UMLS CUI [1,1]
C3177117
UMLS CUI [1,2]
C0441800
UMLS CUI [2]
C1956089
UMLS CUI [3,1]
C0007303
UMLS CUI [3,2]
C0332463
UMLS CUI [4]
C3670825
grade 3: moderate multiple osteophytes, definite narrowing of the joint space, small pseudocystic areas with sclerotic walls in the subchondral bone, possible deformity of bone ends or,
Description

Kellgren-Lawrence score Grade | Osteophytes Moderate Multiple | Narrowed joint space | Sclerosis of subchondral bone of joint | Bone End Deformity

Data type

boolean

Alias
UMLS CUI [1,1]
C3177117
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C1956089
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C0439064
UMLS CUI [3]
C1859695
UMLS CUI [4]
C3670825
UMLS CUI [5,1]
C0262950
UMLS CUI [5,2]
C0444930
UMLS CUI [5,3]
C0302142
grade 4: large osteophytes, marked narrowing of joint space, severe sclerosis and altered shape of the bone ends.
Description

Kellgren-Lawrence score Grade | Osteophytes Large | Narrowed joint space Marked | Sclerosis Severe | Bone End altered

Data type

boolean

Alias
UMLS CUI [1,1]
C3177117
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C1956089
UMLS CUI [2,2]
C0549177
UMLS CUI [3,1]
C1859695
UMLS CUI [3,2]
C1706089
UMLS CUI [4,1]
C0036429
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0262950
UMLS CUI [5,2]
C0444930
UMLS CUI [5,3]
C0392747
subject agrees to participate in follow-up evaluations and complete outcome score sheets (post-injection, 2 weeks, 6 weeks, 3 months and 6 months).
Description

Participation Follow-up Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C1261322
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any inflammatory or neuropathic arthropathy
Description

Arthritis | Neurogenic arthropathy

Data type

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0003892
insufficiency of the collateral ligaments or cruciate ligaments
Description

Collateral ligament Insufficiency | Cruciate ligament Insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0206365
UMLS CUI [1,2]
C0231179
UMLS CUI [2,1]
C0835268
UMLS CUI [2,2]
C0231179
current infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
recent injection (<3 months)
Description

Injection Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C1533685
UMLS CUI [1,2]
C0332185
pregnant/lactating (β-human chorionic gonadotropin pregnancy test will be completed prior to injection)
Description

Pregnancy | Breast Feeding | Serum pregnancy test (B-HCG) Completed

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0430060
UMLS CUI [3,2]
C0205197
allergy or hypersensitivity to the study medications
Description

Hypersensitivity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
currently taking any anti-coagulation medications
Description

Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0003280
subject is unable to make his/her own decision regarding the informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
subject is unable to read/understand english
Description

Lacking Able to read English Language | Comprehension English Language Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Knee Osteoarthritis NCT02295189

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject must be at least 18 years of age and no older than 90 years of age; of either gender
boolean
C0001779 (UMLS CUI [1])
Unilateral primary osteoarthritis of knee Symptomatic | Bilateral primary osteoarthritis of knee Symptomatic | Pain Femorotibial joint | Pain Patellofemoral joint
Item
radiographic evidence of symptomatic osteoarthritis in one or bilateral knees. osteoarthritis will be defined as pain with weight-bearing at the tibiofemoral and/or patellofemoral articulation together with radiographic findings as described below.
boolean
C2893932 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2893930 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0030193 (UMLS CUI [3,1])
C0447795 (UMLS CUI [3,2])
C0030193 (UMLS CUI [4,1])
C0447801 (UMLS CUI [4,2])
Arthralgia Kellgren-Lawrence score
Item
at the painful articulation, radiographic evidence of kellgren-lawrence
boolean
C0003862 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
Kellgren-Lawrence score Grade | Osteophytes | Articular cartilage Narrowing | Sclerosis of subchondral bone of joint
Item
grade 2: definite osteophytes and possible narrowing of joint cartilage associated with sclerosis of subchondral bone or,
boolean
C3177117 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C1956089 (UMLS CUI [2])
C0007303 (UMLS CUI [3,1])
C0332463 (UMLS CUI [3,2])
C3670825 (UMLS CUI [4])
Kellgren-Lawrence score Grade | Osteophytes Moderate Multiple | Narrowed joint space | Sclerosis of subchondral bone of joint | Bone End Deformity
Item
grade 3: moderate multiple osteophytes, definite narrowing of the joint space, small pseudocystic areas with sclerotic walls in the subchondral bone, possible deformity of bone ends or,
boolean
C3177117 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C1956089 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
C1859695 (UMLS CUI [3])
C3670825 (UMLS CUI [4])
C0262950 (UMLS CUI [5,1])
C0444930 (UMLS CUI [5,2])
C0302142 (UMLS CUI [5,3])
Kellgren-Lawrence score Grade | Osteophytes Large | Narrowed joint space Marked | Sclerosis Severe | Bone End altered
Item
grade 4: large osteophytes, marked narrowing of joint space, severe sclerosis and altered shape of the bone ends.
boolean
C3177117 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C1956089 (UMLS CUI [2,1])
C0549177 (UMLS CUI [2,2])
C1859695 (UMLS CUI [3,1])
C1706089 (UMLS CUI [3,2])
C0036429 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0262950 (UMLS CUI [5,1])
C0444930 (UMLS CUI [5,2])
C0392747 (UMLS CUI [5,3])
Participation Follow-up Evaluation
Item
subject agrees to participate in follow-up evaluations and complete outcome score sheets (post-injection, 2 weeks, 6 weeks, 3 months and 6 months).
boolean
C0679823 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Arthritis | Neurogenic arthropathy
Item
any inflammatory or neuropathic arthropathy
boolean
C0003864 (UMLS CUI [1])
C0003892 (UMLS CUI [2])
Collateral ligament Insufficiency | Cruciate ligament Insufficiency
Item
insufficiency of the collateral ligaments or cruciate ligaments
boolean
C0206365 (UMLS CUI [1,1])
C0231179 (UMLS CUI [1,2])
C0835268 (UMLS CUI [2,1])
C0231179 (UMLS CUI [2,2])
Communicable Disease
Item
current infection
boolean
C0009450 (UMLS CUI [1])
Injection Recent
Item
recent injection (<3 months)
boolean
C1533685 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Serum pregnancy test (B-HCG) Completed
Item
pregnant/lactating (β-human chorionic gonadotropin pregnancy test will be completed prior to injection)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430060 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Hypersensitivity Investigational New Drugs
Item
allergy or hypersensitivity to the study medications
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Anticoagulants
Item
currently taking any anti-coagulation medications
boolean
C0003280 (UMLS CUI [1])
Informed Consent Unable
Item
subject is unable to make his/her own decision regarding the informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Lacking Able to read English Language | Comprehension English Language Unable
Item
subject is unable to read/understand english
boolean
C0332268 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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