ID

40729

Description

Safety and Efficacy of an Injectable Medical Device to Treat Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01365260

Link

https://clinicaltrials.gov/show/NCT01365260

Keywords

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

See clinicaltrials.gov

Uploaded on

May 5, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01365260

English

Eligibility Knee Osteoarthritis NCT01365260

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic unilateral knee tibiofemoral oa
Description

Unilateral primary osteoarthritis of knee Femorotibial Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C2893932
UMLS CUI [1,2]
C0447795
UMLS CUI [1,3]
C0231220
radiographic evidence of knee oa of kellgren-lawrence grade ii or iii in one or both knees on a recent 3 months time x-ray
Description

Knee Osteoarthritis Kellgren-Lawrence score X-Ray Computed Tomography | Osteoarthritis Both knees Kellgren-Lawrence score X-Ray Computed Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3177117
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0029408
UMLS CUI [2,2]
C0230434
UMLS CUI [2,3]
C3177117
UMLS CUI [2,4]
C0040405
knee pain within the last 24 hours before assessment more than 40mm on vas
Description

Knee pain Duration | Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C0042815
pain on most days in the last month
Description

Pain days per month

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0556971
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
knee pain equal or more than 80mm on a 100mm vas.
Description

Knee pain Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0042815
pain in the contra lateral knee; more than 30mm on a 100 vas.
Description

Pain Knee Contralateral | Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0441988
UMLS CUI [2]
C0042815
concomitant inflammatory joint disease (e.g. gout, rheumatoid arthritis, history of reiter's syndrome, psoriatic arthritis and ankylosing spondylitis.
Description

Inflammatory joint disease | Gout | Rheumatoid Arthritis | Reiter Syndrome | Arthritis, Psoriatic | Ankylosing spondylitis

Data type

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2]
C0018099
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0035012
UMLS CUI [5]
C0003872
UMLS CUI [6]
C0038013
any condition that may interfere with the measure of pain in the targeted knee
Description

Condition Interferes with Knee pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0231749
concomitant meaningful synovial fluid effusion
Description

Synovial Fluid Effusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0039097
UMLS CUI [1,2]
C0013687
post trauma oa
Description

Status post Trauma Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C3714660
UMLS CUI [1,3]
C0029408
gross ligamentous instability of the knee
Description

Knee instability ligamentous gross

Data type

boolean

Alias
UMLS CUI [1,1]
C0427262
UMLS CUI [1,2]
C0521342
UMLS CUI [1,3]
C0439806
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Similar models

Eligibility Knee Osteoarthritis NCT01365260

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Unilateral primary osteoarthritis of knee Femorotibial Symptomatic
Item
symptomatic unilateral knee tibiofemoral oa
boolean
C2893932 (UMLS CUI [1,1])
C0447795 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Knee Osteoarthritis Kellgren-Lawrence score X-Ray Computed Tomography | Osteoarthritis Both knees Kellgren-Lawrence score X-Ray Computed Tomography
Item
radiographic evidence of knee oa of kellgren-lawrence grade ii or iii in one or both knees on a recent 3 months time x-ray
boolean
C0409959 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0029408 (UMLS CUI [2,1])
C0230434 (UMLS CUI [2,2])
C3177117 (UMLS CUI [2,3])
C0040405 (UMLS CUI [2,4])
Knee pain Duration | Visual Analog Pain Scale
Item
knee pain within the last 24 hours before assessment more than 40mm on vas
boolean
C0231749 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0042815 (UMLS CUI [2])
Pain days per month
Item
pain on most days in the last month
boolean
C0030193 (UMLS CUI [1,1])
C0556971 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Knee pain Visual Analog Pain Scale
Item
knee pain equal or more than 80mm on a 100mm vas.
boolean
C0231749 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
Pain Knee Contralateral | Visual Analog Pain Scale
Item
pain in the contra lateral knee; more than 30mm on a 100 vas.
boolean
C0030193 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0441988 (UMLS CUI [1,3])
C0042815 (UMLS CUI [2])
Inflammatory joint disease | Gout | Rheumatoid Arthritis | Reiter Syndrome | Arthritis, Psoriatic | Ankylosing spondylitis
Item
concomitant inflammatory joint disease (e.g. gout, rheumatoid arthritis, history of reiter's syndrome, psoriatic arthritis and ankylosing spondylitis.
boolean
C0683381 (UMLS CUI [1])
C0018099 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0035012 (UMLS CUI [4])
C0003872 (UMLS CUI [5])
C0038013 (UMLS CUI [6])
Condition Interferes with Knee pain
Item
any condition that may interfere with the measure of pain in the targeted knee
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0231749 (UMLS CUI [1,3])
Synovial Fluid Effusion
Item
concomitant meaningful synovial fluid effusion
boolean
C0039097 (UMLS CUI [1,1])
C0013687 (UMLS CUI [1,2])
Status post Trauma Osteoarthritis
Item
post trauma oa
boolean
C0231290 (UMLS CUI [1,1])
C3714660 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
Knee instability ligamentous gross
Item
gross ligamentous instability of the knee
boolean
C0427262 (UMLS CUI [1,1])
C0521342 (UMLS CUI [1,2])
C0439806 (UMLS CUI [1,3])
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