ID

15500

Beskrivning

Columbia Shoulder Study (CSS); ODM derived from: https://clinicaltrials.gov/show/NCT01488006

Länk

https://clinicaltrials.gov/show/NCT01488006

Nyckelord

  1. 2016-06-01 2016-06-01 -
Uppladdad den

1 juni 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Osteoarthritis of Glenohumeral Joint NCT01488006

Eligibility Osteoarthritis of Glenohumeral Joint NCT01488006

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must be 18 years of age or over.
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patient must have signed the informed consent and release of medical information forms.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
the patient can be a man, postmenopausal woman, or a woman who is likely to become pregnant but is using adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraception or a combination of a condom and spermicide).
Beskrivning

postmenopausal women

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C1999124
patient needs a total shoulder arthroplasty (humeral head and glenoid).
Beskrivning

total shoulder arthroplasty

Datatyp

boolean

Alias
UMLS CUI [1]
C0186657
patient has a diagnosis of primary osteoarthritis.
Beskrivning

primary osteoarthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0409952
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
obstacles, which pose an inordinately high surgical risk, in the judgment of the certified surgeon.
Beskrivning

obstacles

Datatyp

boolean

Alias
UMLS CUI [1]
C1531717
class iv or higher anesthetic risk.
Beskrivning

anesthetic risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002903
UMLS CUI [1,2]
C0035647
patient has a recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair the compliance with the study protocol.
Beskrivning

psychiatric disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patient has had a shoulder fracture.
Beskrivning

shoulder fracture

Datatyp

boolean

Alias
UMLS CUI [1]
C0037006
patient had previous shoulder surgeries with the exception of an arthroscopic debridement procedure.
Beskrivning

shoulder surgeries

Datatyp

boolean

Alias
UMLS CUI [1]
C0186321
the patients has a massive rotator cuff tear (rupture >3 cm or total cicatrisation) demonstrated at time of the surgery that precludes the total shoulder replacement.
Beskrivning

massive rotator cuff tear

Datatyp

boolean

Alias
UMLS CUI [1]
C0263912

Similar models

Eligibility Osteoarthritis of Glenohumeral Joint NCT01488006

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
patient must be 18 years of age or over.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
patient must have signed the informed consent and release of medical information forms.
boolean
C0021430 (UMLS CUI [1])
postmenopausal women
Item
the patient can be a man, postmenopausal woman, or a woman who is likely to become pregnant but is using adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraception or a combination of a condom and spermicide).
boolean
C0232970 (UMLS CUI [1])
C1999124 (UMLS CUI [2])
total shoulder arthroplasty
Item
patient needs a total shoulder arthroplasty (humeral head and glenoid).
boolean
C0186657 (UMLS CUI [1])
primary osteoarthritis
Item
patient has a diagnosis of primary osteoarthritis.
boolean
C0409952 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
obstacles
Item
obstacles, which pose an inordinately high surgical risk, in the judgment of the certified surgeon.
boolean
C1531717 (UMLS CUI [1])
anesthetic risk
Item
class iv or higher anesthetic risk.
boolean
C0002903 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
psychiatric disease
Item
patient has a recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair the compliance with the study protocol.
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
shoulder fracture
Item
patient has had a shoulder fracture.
boolean
C0037006 (UMLS CUI [1])
shoulder surgeries
Item
patient had previous shoulder surgeries with the exception of an arthroscopic debridement procedure.
boolean
C0186321 (UMLS CUI [1])
massive rotator cuff tear
Item
the patients has a massive rotator cuff tear (rupture >3 cm or total cicatrisation) demonstrated at time of the surgery that precludes the total shoulder replacement.
boolean
C0263912 (UMLS CUI [1])

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