ID

37215

Beschreibung

Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty; ODM derived from: https://clinicaltrials.gov/show/NCT02452957

Link

https://clinicaltrials.gov/show/NCT02452957

Stichworte

Versionen (1)
  1. 08.07.19 08.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. Juli 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Shoulder Osteoarthritis NCT02452957

Englisch

Eligibility Shoulder Osteoarthritis NCT02452957

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
a subject must meet all of the following inclusion criteria in order to enter the study:
Beschreibung

Inclusion criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
adult subject 18 years or older,
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis,
Beschreibung

Indication Total Shoulder Replacement | Indication Partial shoulder replacement | Etiology Primary osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0186657
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0186658
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0409952
scapula and proximal humerus must have reached skeletal maturity,
Beschreibung

Scapula Skeletal maturity | Proximal humerus Skeletal maturity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036277
UMLS CUI [1,2]
C0429620
UMLS CUI [2,1]
C0588209
UMLS CUI [2,2]
C0429620
willing and able to comply with the protocol,
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
willing and able to personally sign the informed consent form,
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
subject is legally competent, understands the nature, significance and implications of the clinical investigation, and is able to form a rational intention in the light of these facts.
Beschreibung

Legal competency | Comprehension Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C0680554
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a subject will not be eligible to participate in the study if any of the following conditions is present:
Beschreibung

Study Subject Participation Status Ineligible | Other medical condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
UMLS CUI [2]
C3843040
lack of sufficient sound bone to seat and support the implant, including that resulting from skeletal immaturity, osteoporosis or erosive arthritis,
Beschreibung

Other Coding | Difficulty with Implant | Etiology Bone Immaturity | Difficulty with Implant Due to Osteoporosis | Difficulty with Implant Due to Erosive arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0332218
UMLS CUI [2,2]
C0021102
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0262950
UMLS CUI [3,3]
C0205252
UMLS CUI [4,1]
C0332218
UMLS CUI [4,2]
C0021102
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C0029456
UMLS CUI [5,1]
C0332218
UMLS CUI [5,2]
C0021102
UMLS CUI [5,3]
C0678226
UMLS CUI [5,4]
C4285959
severe walch grade b2 glenoid defined as >60% posterior head displacement and >20% posterior glenoid bone loss,
Beschreibung

Bone of glenoid cavity Grade Classification | Head Posterior Displacement Percentage | Bone of glenoid cavity Posterior Loss Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1179725
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0008902
UMLS CUI [2,1]
C0223683
UMLS CUI [2,2]
C0205095
UMLS CUI [2,3]
C0012727
UMLS CUI [2,4]
C0439165
UMLS CUI [3,1]
C1179725
UMLS CUI [3,2]
C0205095
UMLS CUI [3,3]
C1517945
UMLS CUI [3,4]
C0439165
metal allergies or sensitivity,
Beschreibung

Metal allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0577627
infection at or near the site of implantation,
Beschreibung

Communicable Disease Site of implantation | Communicable Disease Near Site of implantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0230992
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1706276
UMLS CUI [2,3]
C0230992
distant or systemic infection.
Beschreibung

Communicable Disease Distant | Sepsis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0443203
UMLS CUI [2]
C0243026
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Ähnliche Modelle

Eligibility Shoulder Osteoarthritis NCT02452957

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Fulfill
Item
a subject must meet all of the following inclusion criteria in order to enter the study:
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Adult | Age
Item
adult subject 18 years or older,
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Indication Total Shoulder Replacement | Indication Partial shoulder replacement | Etiology Primary osteoarthritis
Item
clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis,
boolean
C3146298 (UMLS CUI [1,1])
C0186657 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0186658 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0409952 (UMLS CUI [3,2])
Scapula Skeletal maturity | Proximal humerus Skeletal maturity
Item
scapula and proximal humerus must have reached skeletal maturity,
boolean
C0036277 (UMLS CUI [1,1])
C0429620 (UMLS CUI [1,2])
C0588209 (UMLS CUI [2,1])
C0429620 (UMLS CUI [2,2])
Protocol Compliance
Item
willing and able to comply with the protocol,
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
willing and able to personally sign the informed consent form,
boolean
C0021430 (UMLS CUI [1])
Legal competency | Comprehension Study Protocol
Item
subject is legally competent, understands the nature, significance and implications of the clinical investigation, and is able to form a rational intention in the light of these facts.
boolean
C0680554 (UMLS CUI [1])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status Ineligible | Other medical condition
Item
a subject will not be eligible to participate in the study if any of the following conditions is present:
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2])
Other Coding | Difficulty with Implant | Etiology Bone Immaturity | Difficulty with Implant Due to Osteoporosis | Difficulty with Implant Due to Erosive arthritis
Item
lack of sufficient sound bone to seat and support the implant, including that resulting from skeletal immaturity, osteoporosis or erosive arthritis,
boolean
C3846158 (UMLS CUI [1])
C0332218 (UMLS CUI [2,1])
C0021102 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0262950 (UMLS CUI [3,2])
C0205252 (UMLS CUI [3,3])
C0332218 (UMLS CUI [4,1])
C0021102 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0029456 (UMLS CUI [4,4])
C0332218 (UMLS CUI [5,1])
C0021102 (UMLS CUI [5,2])
C0678226 (UMLS CUI [5,3])
C4285959 (UMLS CUI [5,4])
Bone of glenoid cavity Grade Classification | Head Posterior Displacement Percentage | Bone of glenoid cavity Posterior Loss Percentage
Item
severe walch grade b2 glenoid defined as >60% posterior head displacement and >20% posterior glenoid bone loss,
boolean
C1179725 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
C0223683 (UMLS CUI [2,1])
C0205095 (UMLS CUI [2,2])
C0012727 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
C1179725 (UMLS CUI [3,1])
C0205095 (UMLS CUI [3,2])
C1517945 (UMLS CUI [3,3])
C0439165 (UMLS CUI [3,4])
Metal allergy
Item
metal allergies or sensitivity,
boolean
C0577627 (UMLS CUI [1])
Communicable Disease Site of implantation | Communicable Disease Near Site of implantation
Item
infection at or near the site of implantation,
boolean
C0009450 (UMLS CUI [1,1])
C0230992 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1706276 (UMLS CUI [2,2])
C0230992 (UMLS CUI [2,3])
Communicable Disease Distant | Sepsis
Item
distant or systemic infection.
boolean
C0009450 (UMLS CUI [1,1])
C0443203 (UMLS CUI [1,2])
C0243026 (UMLS CUI [2])
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