ID

36726

Beschrijving

TITAN™ Reverse Shoulder System; ODM derived from: https://clinicaltrials.gov/show/NCT02204228

Link

https://clinicaltrials.gov/show/NCT02204228

Trefwoorden

Versies (1)
  1. 04-06-19 04-06-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 juni 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Shoulder NCT02204228

Engels

Eligibility Osteoarthritis of the Shoulder NCT02204228

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with grossly deficient rotator cuff with severe arthropathy or subjects with failed joint replacement with grossly deficient rotator cuff
Beschrijving

Rotator Cuff Deficient | Arthropathy Severe | Joint Replacement failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085515
UMLS CUI [1,2]
C0011155
UMLS CUI [2,1]
C0022408
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0185317
UMLS CUI [3,2]
C0231175
subjects with a shoulder joint anatomically and structurally suited to receive the device
Beschrijving

Shoulder joint suitable Medical Device

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037009
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0025080
subjects at least 21 years of age and skeletally mature at the time of surgery
Beschrijving

Age | Skeleton Mature

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0816871
UMLS CUI [2,2]
C0205286
subject provided consent to participate in the clinical study (having signed the informed consent form)
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects without a functional deltoid muscle
Beschrijving

Deltoid muscle Functional Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1304986
UMLS CUI [1,2]
C0205245
UMLS CUI [1,3]
C0332197
subjects with active local or systemic infection
Beschrijving

Local infection | Sepsis

Datatype

boolean

Alias
UMLS CUI [1]
C1400591
UMLS CUI [2]
C0243026
subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
Beschrijving

Bone structure of proximal humerus Inadequate | Bone Glenoid fossa Inadequate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0588209
UMLS CUI [1,2]
C0205412
UMLS CUI [2,1]
C0262950
UMLS CUI [2,2]
C1261046
UMLS CUI [2,3]
C0205412
subjects with poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid
Beschrijving

Bone Quality Poor | Osteoporosis | At risk Fracture

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C0332306
UMLS CUI [1,3]
C0542537
UMLS CUI [2]
C0029456
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0016658
subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity
Beschrijving

Deficiency Muscular | Deficiency Neurologic | Vascular deficiency | At risk Extremity affected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011155
UMLS CUI [1,2]
C0442025
UMLS CUI [2,1]
C0011155
UMLS CUI [2,2]
C0205494
UMLS CUI [3]
C1394931
UMLS CUI [4,1]
C1444641
UMLS CUI [4,2]
C0015385
UMLS CUI [4,3]
C1314939
subjects with known metal allergies
Beschrijving

Metal allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0577627
subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits
Beschrijving

Compliance behavior At risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1444641
subjects who are prisoners
Beschrijving

Prisoners

Datatype

boolean

Alias
UMLS CUI [1]
C0033167
female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
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Similar models

Eligibility Osteoarthritis of the Shoulder NCT02204228

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Rotator Cuff Deficient | Arthropathy Severe | Joint Replacement failed
Item
subjects with grossly deficient rotator cuff with severe arthropathy or subjects with failed joint replacement with grossly deficient rotator cuff
boolean
C0085515 (UMLS CUI [1,1])
C0011155 (UMLS CUI [1,2])
C0022408 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0185317 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
Shoulder joint suitable Medical Device
Item
subjects with a shoulder joint anatomically and structurally suited to receive the device
boolean
C0037009 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
Age | Skeleton Mature
Item
subjects at least 21 years of age and skeletally mature at the time of surgery
boolean
C0001779 (UMLS CUI [1])
C0816871 (UMLS CUI [2,1])
C0205286 (UMLS CUI [2,2])
Informed Consent
Item
subject provided consent to participate in the clinical study (having signed the informed consent form)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Deltoid muscle Functional Absent
Item
subjects without a functional deltoid muscle
boolean
C1304986 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Local infection | Sepsis
Item
subjects with active local or systemic infection
boolean
C1400591 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
Bone structure of proximal humerus Inadequate | Bone Glenoid fossa Inadequate
Item
subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
boolean
C0588209 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0262950 (UMLS CUI [2,1])
C1261046 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Bone Quality Poor | Osteoporosis | At risk Fracture
Item
subjects with poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid
boolean
C0262950 (UMLS CUI [1,1])
C0332306 (UMLS CUI [1,2])
C0542537 (UMLS CUI [1,3])
C0029456 (UMLS CUI [2])
C1444641 (UMLS CUI [3,1])
C0016658 (UMLS CUI [3,2])
Deficiency Muscular | Deficiency Neurologic | Vascular deficiency | At risk Extremity affected
Item
subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity
boolean
C0011155 (UMLS CUI [1,1])
C0442025 (UMLS CUI [1,2])
C0011155 (UMLS CUI [2,1])
C0205494 (UMLS CUI [2,2])
C1394931 (UMLS CUI [3])
C1444641 (UMLS CUI [4,1])
C0015385 (UMLS CUI [4,2])
C1314939 (UMLS CUI [4,3])
Metal allergy
Item
subjects with known metal allergies
boolean
C0577627 (UMLS CUI [1])
Compliance behavior At risk
Item
subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits
boolean
C1321605 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
Prisoners
Item
subjects who are prisoners
boolean
C0033167 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
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