ID

40788

Descrição

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

Link

https://clinicaltrials.gov/show/NCT02295189

Palavras-chave

Versões (1)
  1. 13/05/2020 13/05/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

13 de maio de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02295189

Inglês

Eligibility Knee Osteoarthritis NCT02295189

1 Formulários  
Inclusion Criteria
Descrição

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
Descrição

Age

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

Arthralgia Kellgren-Lawrence score

Tipo de dados

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,
Descrição

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

Tipo de dados

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,
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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).
Descrição

Participation Follow-up Evaluation

Tipo de dados

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
any inflammatory or neuropathic arthropathy
Descrição

Arthritis | Neurogenic arthropathy

Tipo de dados

boolean

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

Collateral ligament Insufficiency | Cruciate ligament Insufficiency

Tipo de dados

boolean

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

Communicable Disease

Tipo de dados

boolean

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

Injection Recent

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Hypersensitivity Investigational New Drugs

Tipo de dados

boolean

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

Anticoagulants

Tipo de dados

boolean

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

Informed Consent Unable

Tipo de dados

boolean

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

Lacking Able to read English Language | Comprehension English Language Unable

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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