ID

22269

Descripción

A Single Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-ceramic Bearing in Primary Total Hip Replacement; ODM derived from: https://clinicaltrials.gov/show/NCT00872222

Link

https://clinicaltrials.gov/show/NCT00872222

Palabras clave

Versiones (1)
  1. 28/5/17 28/5/17 -
Subido en

28 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00872222

Inglés

Eligibility Rheumatoid Arthritis NCT00872222

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
i) male or female subjects, aged between 18 and 70 years inclusive.
Descripción

gender, age

Tipo de datos

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.
Descripción

informed consent

Tipo de datos

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.
Descripción

compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
iv) subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.
Descripción

total hip replacement, cementless acetabular components

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040508
UMLS CUI [1,2]
C0182473
UMLS CUI [1,3]
C0005934
Exclusion Criteria
Descripción

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.
Descripción

comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
ii) subjects undergoing revision hip replacement.
Descripción

revision hip replacement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0186201
iii) women who are pregnant.
Descripción

pregnancy

Tipo de datos

boolean

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

substance abuse, psychological disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0004936
v) subjects who have participated in a clinical study with an investigational product in the last 12 months.
Descripción

study participation, investigational product

Tipo de datos

boolean

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

injury ligitation claims

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3263723
UMLS CUI [1,2]
C0079706
UMLS CUI [1,3]
C0021677
vii) subjects undergoing a simultaneous bilateral hip operation.
Descripción

simultaneous bilateral hip operation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0596706
UMLS CUI [1,2]
C0238767
UMLS CUI [1,3]
C0521115
viii) subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
Descripción

investigation participation with contralateral hip

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0019552
UMLS CUI [1,3]
C0441988
ix) subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
Descripción

contralateral hip replacement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040508
UMLS CUI [1,2]
C0441988
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Similar models

Eligibility Rheumatoid Arthritis NCT00872222

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
gender, age
Item
i) male or female subjects, aged between 18 and 70 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 replacement, cementless acetabular components
Item
iv) subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.
boolean
C0040508 (UMLS CUI [1,1])
C0182473 (UMLS CUI [1,2])
C0005934 (UMLS CUI [1,3])
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])
revision hip replacement
Item
ii) subjects undergoing revision hip replacement.
boolean
C0186201 (UMLS CUI [1])
pregnancy
Item
iii) women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
substance abuse, psychological disorders
Item
iv) 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
v) subjects who have participated in a clinical study with an investigational product in the last 12 months.
boolean
C2348568 (UMLS CUI [1,1])
C3898691 (UMLS CUI [1,2])
injury ligitation claims
Item
vi) 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])
simultaneous bilateral hip operation
Item
vii) subjects undergoing a simultaneous bilateral hip operation.
boolean
C0596706 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0521115 (UMLS CUI [1,3])
investigation participation with contralateral hip
Item
viii) subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
boolean
C2348568 (UMLS CUI [1,1])
C0019552 (UMLS CUI [1,2])
C0441988 (UMLS CUI [1,3])
contralateral hip replacement
Item
ix) subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
boolean
C0040508 (UMLS CUI [1,1])
C0441988 (UMLS CUI [1,2])
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