ID

42228

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00872547

Nyckelord

Versioner (2)
  1. 2017-05-28 2017-05-28 -
  2. 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
Uppladdad den

13 april 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00872547

Engelsk

Eligibility Rheumatoid Arthritis NCT00872547

1 Formulär  
Criteria
Beskrivning

Criteria

i) male or female subjects, aged between 18 and 65 years inclusive.
Beskrivning

gender, age

Datatyp

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.
Beskrivning

informed consent

Datatyp

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.
Beskrivning

compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
inclusion criteria for depuy asr™ resurfacing system:
Beskrivning

inclusion criteria

Datatyp

boolean

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

primary osteoarthritis, hip resurfacing arthroplasty

Datatyp

boolean

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

inclusion criteria

Datatyp

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.
Beskrivning

hip resurfacing arthroplasty

Datatyp

boolean

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

exclusion criteria

Datatyp

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.
Beskrivning

comorbidity

Datatyp

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.
Beskrivning

renal function

Datatyp

boolean

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

metal sensitivity

Datatyp

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.
Beskrivning

communicable diseases

Datatyp

boolean

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

pregnancy

Datatyp

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.
Beskrivning

substance abuse, psychological disorders

Datatyp

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).
Beskrivning

study participation, investigational product

Datatyp

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.
Beskrivning

study participation with ionizing radiation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0034538
ix) subjects who are currently involved in any injury litigation claims.
Beskrivning

injury litigation claims

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3263723
UMLS CUI [1,2]
C0079706
UMLS CUI [1,3]
C0021677
x) subjects who are undergoing corticosteroid treatment.
Beskrivning

corticosteroid treatment

Datatyp

boolean

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

joint sepsis

Datatyp

boolean

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

exclusion criteria

Datatyp

boolean

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

osteoporosis

Datatyp

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.
Beskrivning

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

Datatyp

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°.
Beskrivning

caput-collum-diaphysis angle

Datatyp

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.
Beskrivning

hip irradiation

Datatyp

boolean

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

Eligibility Rheumatoid Arthritis NCT00872547

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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