ID

31262

Beschrijving

Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA); ODM derived from: https://clinicaltrials.gov/show/NCT00665548

Link

https://clinicaltrials.gov/show/NCT00665548

Trefwoorden

Versies (1)
  1. 05-08-18 05-08-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 augustus 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00665548

Engels

Eligibility Osteoarthritis NCT00665548

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
40 years and older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subjects who are willing and able to comply with x-ray and mri procedures
Beschrijving

Compliance behavior X-ray Willing | Compliance behavior MRI Willing | Compliance behavior X-ray Able | Compliance behavior MRI Able

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0034571
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0024485
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0034571
UMLS CUI [3,3]
C0085732
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0024485
UMLS CUI [4,3]
C0085732
evidence of a personally signed and dated consent document
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
additional inclusion for normal controls:
Beschrijving

Inclusion criteria Controls Normal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
UMLS CUI [1,3]
C0205307
infrequent knee pain, aching, or stiffness during the past year or infrequent use of medication for treatment of knee pain during the past year
Beschrijving

Knee pain Infrequent | Knee stiffness Infrequent | Pharmacotherapy Infrequent Knee pain

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0521114
UMLS CUI [2,1]
C0240129
UMLS CUI [2,2]
C0521114
UMLS CUI [3,1]
C0013216
UMLS CUI [3,2]
C0521114
UMLS CUI [3,3]
C0231749
no evidence of oa on either knee (i.e. k-l grade = 0 diagnosed by knee radiography)
Beschrijving

Knee Osteoarthritis Absent Kellgren-Lawrence score Radiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C3177117
UMLS CUI [1,4]
C0845957
additional inclusion for oa patients:
Beschrijving

Inclusion criteria Patients Osteoarthritis

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0029408
pain, aching, or stiffness on most days of a month during the past year; or use of medication for treatment of knee pain on most days of a month during the past year
Beschrijving

Pain Frequently | Aching Frequently | Stiffness Frequently | Pharmacotherapy Frequently Knee pain

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0332183
UMLS CUI [2,1]
C0234238
UMLS CUI [2,2]
C0332183
UMLS CUI [3,1]
C0427008
UMLS CUI [3,2]
C0332183
UMLS CUI [4,1]
C0013216
UMLS CUI [4,2]
C0332183
UMLS CUI [4,3]
C0231749
kellgren-lawrence grade 2 or 3 of the study knee obtained on a standard knee radiograph (with either the same or less severe oa, or no oa in the contralateral knee)
Beschrijving

Index Knee Kellgren-Lawrence score Radiography | Knee Osteoarthritis Contralateral | Knee Osteoarthritis Contralateral Moderate | Knee Osteoarthritis Contralateral Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C3177117
UMLS CUI [1,4]
C0845957
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C0441988
UMLS CUI [3,1]
C0409959
UMLS CUI [3,2]
C0441988
UMLS CUI [3,3]
C0205081
UMLS CUI [4,1]
C0409959
UMLS CUI [4,2]
C0441988
UMLS CUI [4,3]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is unable to undergo mri because of contraindication
Beschrijving

Medical contraindication MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
women at risk of pregnancy
Beschrijving

Gender At risk Pregnancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0032961
weight greater than 250 lbs
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
history of surgery in the study knee
Beschrijving

Operative Surgical Procedures Index Knee

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0022742
history of other diseases involving the study knee joint including inflammatory joint diseases, crystalline disease, and infection of the study knee
Beschrijving

Disease Involving Index Knee joint | inflammatory joint disease | Crystal Arthropathy | Communicable Disease Index Knee

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C2986546
UMLS CUI [1,4]
C0022745
UMLS CUI [2]
C0683381
UMLS CUI [3]
C0152087
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C2986546
UMLS CUI [4,3]
C0022742
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Similar models

Eligibility Osteoarthritis NCT00665548

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
40 years and older
boolean
C0001779 (UMLS CUI [1])
Compliance behavior X-ray Willing | Compliance behavior MRI Willing | Compliance behavior X-ray Able | Compliance behavior MRI Able
Item
subjects who are willing and able to comply with x-ray and mri procedures
boolean
C1321605 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C1321605 (UMLS CUI [3,1])
C0034571 (UMLS CUI [3,2])
C0085732 (UMLS CUI [3,3])
C1321605 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0085732 (UMLS CUI [4,3])
Informed Consent
Item
evidence of a personally signed and dated consent document
boolean
C0021430 (UMLS CUI [1])
Inclusion criteria Controls Normal
Item
additional inclusion for normal controls:
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Knee pain Infrequent | Knee stiffness Infrequent | Pharmacotherapy Infrequent Knee pain
Item
infrequent knee pain, aching, or stiffness during the past year or infrequent use of medication for treatment of knee pain during the past year
boolean
C0231749 (UMLS CUI [1,1])
C0521114 (UMLS CUI [1,2])
C0240129 (UMLS CUI [2,1])
C0521114 (UMLS CUI [2,2])
C0013216 (UMLS CUI [3,1])
C0521114 (UMLS CUI [3,2])
C0231749 (UMLS CUI [3,3])
Knee Osteoarthritis Absent Kellgren-Lawrence score Radiography
Item
no evidence of oa on either knee (i.e. k-l grade = 0 diagnosed by knee radiography)
boolean
C0409959 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3177117 (UMLS CUI [1,3])
C0845957 (UMLS CUI [1,4])
Inclusion criteria Patients Osteoarthritis
Item
additional inclusion for oa patients:
boolean
C1512693 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
Pain Frequently | Aching Frequently | Stiffness Frequently | Pharmacotherapy Frequently Knee pain
Item
pain, aching, or stiffness on most days of a month during the past year; or use of medication for treatment of knee pain on most days of a month during the past year
boolean
C0030193 (UMLS CUI [1,1])
C0332183 (UMLS CUI [1,2])
C0234238 (UMLS CUI [2,1])
C0332183 (UMLS CUI [2,2])
C0427008 (UMLS CUI [3,1])
C0332183 (UMLS CUI [3,2])
C0013216 (UMLS CUI [4,1])
C0332183 (UMLS CUI [4,2])
C0231749 (UMLS CUI [4,3])
Index Knee Kellgren-Lawrence score Radiography | Knee Osteoarthritis Contralateral | Knee Osteoarthritis Contralateral Moderate | Knee Osteoarthritis Contralateral Absent
Item
kellgren-lawrence grade 2 or 3 of the study knee obtained on a standard knee radiograph (with either the same or less severe oa, or no oa in the contralateral knee)
boolean
C2986546 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C3177117 (UMLS CUI [1,3])
C0845957 (UMLS CUI [1,4])
C0409959 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
C0409959 (UMLS CUI [3,1])
C0441988 (UMLS CUI [3,2])
C0205081 (UMLS CUI [3,3])
C0409959 (UMLS CUI [4,1])
C0441988 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication MRI
Item
subject is unable to undergo mri because of contraindication
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Gender At risk Pregnancy
Item
women at risk of pregnancy
boolean
C0079399 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Body Weight
Item
weight greater than 250 lbs
boolean
C0005910 (UMLS CUI [1])
Operative Surgical Procedures Index Knee
Item
history of surgery in the study knee
boolean
C0543467 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
Disease Involving Index Knee joint | inflammatory joint disease | Crystal Arthropathy | Communicable Disease Index Knee
Item
history of other diseases involving the study knee joint including inflammatory joint diseases, crystalline disease, and infection of the study knee
boolean
C0012634 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0022745 (UMLS CUI [1,4])
C0683381 (UMLS CUI [2])
C0152087 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C2986546 (UMLS CUI [4,2])
C0022742 (UMLS CUI [4,3])
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