ID

22267

Descrição

A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement; ODM derived from: https://clinicaltrials.gov/show/NCT00872066

Link

https://clinicaltrials.gov/show/NCT00872066

Palavras-chave

  1. 28/05/2017 28/05/2017 -
Transferido a

28 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00872066

Eligibility Rheumatoid Arthritis NCT00872066

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
i) male or female subjects, aged between 18 and 75 years (inclusive).
Descrição

gender, age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
ii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
iii) subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Descrição

compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
iv) subjects requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.
Descrição

total hip arthroplasty with cemented femoral component

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040508
UMLS CUI [1,2]
C0492265
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
Descrição

comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
ii) women who are pregnant.
Descrição

pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
iii) subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
Descrição

substance abuse, psychological disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0004936
iv) subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
Descrição

study participation, investigational product

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3898691
v) subjects who are currently involved in any injury litigation claims.
Descrição

injury litigation claims

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3263723
UMLS CUI [1,2]
C0079706
UMLS CUI [1,3]
C0021677
vi) subjects with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's instructions for use.
Descrição

bone cement contraindication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005934
UMLS CUI [1,2]
C0522473

Similar models

Eligibility Rheumatoid Arthritis NCT00872066

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
gender, age
Item
i) male or female subjects, aged between 18 and 75 years (inclusive).
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
informed consent
Item
ii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
boolean
C0021430 (UMLS CUI [1])
compliance
Item
iii) subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
boolean
C1321605 (UMLS CUI [1])
total hip arthroplasty with cemented femoral component
Item
iv) subjects requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.
boolean
C0040508 (UMLS CUI [1,1])
C0492265 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
boolean
C0009488 (UMLS CUI [1])
pregnancy
Item
ii) women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
substance abuse, psychological disorders
Item
iii) subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
study participation, investigational product
Item
iv) subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
boolean
C2348568 (UMLS CUI [1,1])
C3898691 (UMLS CUI [1,2])
injury litigation claims
Item
v) subjects who are currently involved in any injury litigation claims.
boolean
C3263723 (UMLS CUI [1,1])
C0079706 (UMLS CUI [1,2])
C0021677 (UMLS CUI [1,3])
bone cement contraindication
Item
vi) subjects with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's instructions for use.
boolean
C0005934 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])

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