Informatie:
Fout:
ID
42228
Beschrijving
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
Trefwoorden
Versies (2)
- 28-05-17 28-05-17 -
- 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
Geüploaded op
13 april 2021
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00872547
Eligibility Rheumatoid Arthritis NCT00872547
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT00872547
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
gender, age
Item
i) male or female subjects, aged between 18 and 65 years inclusive.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0019552 (UMLS CUI [1,2])