Informações:
Falhas:
ID
12127
Descrição
Total Ankle Replacement Versus Arthrodesis Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02128555
Link
https://clinicaltrials.gov/show/NCT02128555
Palavras-chave
Versões (1)
- 28/09/2015 28/09/2015 - Julian Varghese
Transferido a
28 de setembro de 2015
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT02128555
Eligibility Osteoarthritis NCT02128555
- StudyEvent: Eligibility
Similar models
Eligibility Osteoarthritis NCT02128555
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
end-stage ankle osteoarthritis
Item
diagnosis of end-stage ankle osteoarthritis
boolean
C0409931 (UMLS CUI [1,1])
C0205088 (UMLS CUI [1,2])
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])
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])
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])
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])
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])