ID

12127

Beskrivning

Total Ankle Replacement Versus Arthrodesis Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02128555

Länk

https://clinicaltrials.gov/show/NCT02128555

Nyckelord

  1. 2015-09-28 2015-09-28 - Julian Varghese
Uppladdad den

28 september 2015

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Osteoarthritis NCT02128555

Eligibility Osteoarthritis NCT02128555

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of end-stage ankle osteoarthritis
Beskrivning

end-stage ankle osteoarthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0409931
UMLS CUI [1,2]
C0205088
aged 50-85 years inclusive
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
the surgeon believes the patient is suitable for both tar and arthrodesis (having considered deformity, stability, bone quality, soft tissue envelope, and neurovascular status)
Beskrivning

Eligibility Determination; Total ankle replacement | Eligibility Determination; Arthrodesi

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C0188664
UMLS CUI [2,1]
C0013893
UMLS CUI [2,2]
C0003881
the patient is able to read and understand the patient information sheet (pis) and trial procedures
Beskrivning

able to read and understand information sheet

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
the patient is willing and able to provide written informed consent
Beskrivning

patient is willing and able to provide written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
Beskrivning

surgery planned within 1 year

Datatyp

boolean

Alias
UMLS CUI [1]
C0003881
more than 4 lower limb joints fused (including contralateral limb, but excluding proximal interphalangeal joint fusions)
Beskrivning

4 lower limb joints fused

Datatyp

boolean

Alias
UMLS CUI [1]
C0003881
• unable to have mri/ct scan (e.g. severe claustrophobia or contraindication for either scan)
Beskrivning

unable to have mri/ct scan (e.g. severe claustrophobia or contraindication for either scan)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C0522473
UMLS CUI [2,2]
C0040405
history of local bone or joint infection
Beskrivning

history of local bone or joint infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0851989
any co-morbidity, which, in the opinion of the investigator, is severe enough to; interfere with the patient's ability to complete the study assessments or; presents an unacceptable risk to the patient's safety
Beskrivning

patient safety comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0150755
UMLS CUI [1,2]
C0009488
participant in another clinical trial that would materially impact on their participation in this study
Beskrivning

participation status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Osteoarthritis NCT02128555

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
end-stage ankle osteoarthritis
Item
diagnosis of end-stage ankle osteoarthritis
boolean
C0409931 (UMLS CUI [1,1])
C0205088 (UMLS CUI [1,2])
Age
Item
aged 50-85 years inclusive
boolean
C0001779 (UMLS CUI [1])
Eligibility Determination; Total ankle replacement | Eligibility Determination; Arthrodesi
Item
the surgeon believes the patient is suitable for both tar and arthrodesis (having considered deformity, stability, bone quality, soft tissue envelope, and neurovascular status)
boolean
C0013893 (UMLS CUI [1,1])
C0188664 (UMLS CUI [1,2])
C0013893 (UMLS CUI [2,1])
C0003881 (UMLS CUI [2,2])
able to read and understand information sheet
Item
the patient is able to read and understand the patient information sheet (pis) and trial procedures
boolean
C0021430 (UMLS CUI [1])
patient is willing and able to provide written informed consent
Item
the patient is willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
surgery planned within 1 year
Item
previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
boolean
C0003881 (UMLS CUI [1])
4 lower limb joints fused
Item
more than 4 lower limb joints fused (including contralateral limb, but excluding proximal interphalangeal joint fusions)
boolean
C0003881 (UMLS CUI [1])
unable to have mri/ct scan (e.g. severe claustrophobia or contraindication for either scan)
Item
• unable to have mri/ct scan (e.g. severe claustrophobia or contraindication for either scan)
boolean
C0522473 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0522473 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
history of local bone or joint infection
Item
history of local bone or joint infection
boolean
C0851989 (UMLS CUI [1])
patient safety comorbidity
Item
any co-morbidity, which, in the opinion of the investigator, is severe enough to; interfere with the patient's ability to complete the study assessments or; presents an unacceptable risk to the patient's safety
boolean
C0150755 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
participation status
Item
participant in another clinical trial that would materially impact on their participation in this study
boolean
C2348568 (UMLS CUI [1])

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