ID

12127

Description

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

Link

https://clinicaltrials.gov/show/NCT02128555

Keywords

  1. 9/28/15 9/28/15 - Julian Varghese
Uploaded on

September 28, 2015

DOI

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License

Creative Commons BY 4.0

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Eligibility Osteoarthritis NCT02128555

Eligibility Osteoarthritis NCT02128555

Inclusion Criteria
Description

Inclusion Criteria

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

end-stage ankle osteoarthritis

Data type

boolean

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

Age

Data type

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)
Description

Eligibility Determination; Total ankle replacement | Eligibility Determination; Arthrodesi

Data type

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
Description

able to read and understand information sheet

Data type

boolean

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

patient is willing and able to provide written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

surgery planned within 1 year

Data type

boolean

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

4 lower limb joints fused

Data type

boolean

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

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

Data type

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
Description

history of local bone or joint infection

Data type

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
Description

patient safety comorbidity

Data type

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
Description

participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Osteoarthritis NCT02128555

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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