ID

42228

Descrição

Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement; ODM derived from: https://clinicaltrials.gov/show/NCT00872547

Link

https://clinicaltrials.gov/show/NCT00872547

Palavras-chave

Versões (2)
  1. 28/05/2017 28/05/2017 -
  2. 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
Transferido a

13 de abril de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00872547

Inglês

Eligibility Rheumatoid Arthritis NCT00872547

1 Formulários  
Criteria
Descrição

Criteria

i) male or female subjects, aged between 18 and 65 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
inclusion criteria for depuy asr™ resurfacing system:
Descrição

inclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1512693
i) subjects with primary osteoarthritis indicated for standard mom hip resurfacing arthroplasty with cementless fixation in the acetabulum.
Descrição

primary osteoarthritis, hip resurfacing arthroplasty

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0409952
UMLS CUI [1,2]
C1719285
inclusion criteria for asr™ xl head system:
Descrição

inclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1512693
i) subjects whose bone morphology and bone quality mean that standard mom hip resurfacing arthroplasty is not indicated, but for whom cementless fixation in the acetabulum and receipt of a large mom bearing are still possible.
Descrição

hip resurfacing arthroplasty

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1719285
general exclusion criteria:
Descrição

exclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
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) subjects with compromised renal function defined as those whose measured values lie outside the normal range for a particular investigational site.
Descrição

renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
iii) subjects with proven metal sensitivity.
Descrição

metal sensitivity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025552
UMLS CUI [1,2]
C0020517
iv) subjects with infectious, highly communicable diseases, which may limit follow-up i.e. active tuberculosis, hepatitis, immuno-compromised conditions, etc.
Descrição

communicable diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
v) women who are pregnant or who intend to become pregnant within 2 years of surgery.
Descrição

pregnancy

Tipo de dados

boolean

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

substance abuse, psychological disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0004936
vii) 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
viii) subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation.
Descrição

study participation with ionizing radiation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0034538
ix) 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
x) subjects who are undergoing corticosteroid treatment.
Descrição

corticosteroid treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149783
xi) subjects with active or recent joint sepsis.
Descrição

joint sepsis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0851989
additional exclusion criteria for depuy asr™:
Descrição

exclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
i) subjects with proven significant osteoporosis and poor bone quality.
Descrição

osteoporosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029456
ii) subjects with marked atrophy or deformity in the upper femur, skeletal immaturity, or where loss of musculature or neuromuscular disease would render the procedure unjustifiable.
Descrição

femur deformity, skeletal immaturity, loss of musculature, neuromuscular disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0343296
UMLS CUI [2]
C3825673
UMLS CUI [3,1]
C0026846
UMLS CUI [3,2]
C0027868
iii) subjects whose anatomical ccd angle is below 120°.
Descrição

caput-collum-diaphysis angle

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0015811
UMLS CUI [1,2]
C0015815
UMLS CUI [1,3]
C0588193
UMLS CUI [1,4]
C0205143
iv) subjects who have undergone irradiation of the affected hip.
Descrição

hip irradiation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0019552
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Similar models

Eligibility Rheumatoid Arthritis NCT00872547

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
gender, age
Item
i) male or female subjects, aged between 18 and 65 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])
inclusion criteria
Item
inclusion criteria for depuy asr™ resurfacing system:
boolean
C1512693 (UMLS CUI [1])
primary osteoarthritis, hip resurfacing arthroplasty
Item
i) subjects with primary osteoarthritis indicated for standard mom hip resurfacing arthroplasty with cementless fixation in the acetabulum.
boolean
C0409952 (UMLS CUI [1,1])
C1719285 (UMLS CUI [1,2])
inclusion criteria
Item
inclusion criteria for asr™ xl head system:
boolean
C1512693 (UMLS CUI [1])
hip resurfacing arthroplasty
Item
i) subjects whose bone morphology and bone quality mean that standard mom hip resurfacing arthroplasty is not indicated, but for whom cementless fixation in the acetabulum and receipt of a large mom bearing are still possible.
boolean
C1719285 (UMLS CUI [1])
exclusion criteria
Item
general exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
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])
renal function
Item
ii) subjects with compromised renal function defined as those whose measured values lie outside the normal range for a particular investigational site.
boolean
C0232804 (UMLS CUI [1])
metal sensitivity
Item
iii) subjects with proven metal sensitivity.
boolean
C0025552 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
communicable diseases
Item
iv) subjects with infectious, highly communicable diseases, which may limit follow-up i.e. active tuberculosis, hepatitis, immuno-compromised conditions, etc.
boolean
C0009450 (UMLS CUI [1])
pregnancy
Item
v) women who are pregnant or who intend to become pregnant within 2 years of surgery.
boolean
C0032961 (UMLS CUI [1])
substance abuse, psychological disorders
Item
vi) subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
study participation, investigational product
Item
vii) 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])
study participation with ionizing radiation
Item
viii) subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation.
boolean
C2348568 (UMLS CUI [1,1])
C0034538 (UMLS CUI [1,2])
injury litigation claims
Item
ix) 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])
corticosteroid treatment
Item
x) subjects who are undergoing corticosteroid treatment.
boolean
C0149783 (UMLS CUI [1])
joint sepsis
Item
xi) subjects with active or recent joint sepsis.
boolean
C0851989 (UMLS CUI [1])
exclusion criteria
Item
additional exclusion criteria for depuy asr™:
boolean
C0680251 (UMLS CUI [1])
osteoporosis
Item
i) subjects with proven significant osteoporosis and poor bone quality.
boolean
C0029456 (UMLS CUI [1])
femur deformity, skeletal immaturity, loss of musculature, neuromuscular disease
Item
ii) subjects with marked atrophy or deformity in the upper femur, skeletal immaturity, or where loss of musculature or neuromuscular disease would render the procedure unjustifiable.
boolean
C0343296 (UMLS CUI [1])
C3825673 (UMLS CUI [2])
C0026846 (UMLS CUI [3,1])
C0027868 (UMLS CUI [3,2])
caput-collum-diaphysis angle
Item
iii) subjects whose anatomical ccd angle is below 120°.
boolean
C0015811 (UMLS CUI [1,1])
C0015815 (UMLS CUI [1,2])
C0588193 (UMLS CUI [1,3])
C0205143 (UMLS CUI [1,4])
hip irradiation
Item
iv) subjects who have undergone irradiation of the affected hip.
boolean
C1522449 (UMLS CUI [1,1])
C0019552 (UMLS CUI [1,2])
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