ID

13127

Beschreibung

Mobile - Bearing Knee Study; ODM derived from: https://clinicaltrials.gov/show/NCT00765362

Link

https://clinicaltrials.gov/show/NCT00765362

Stichworte

Versionen (1)
  1. 18/01/16 18/01/16 -
Hochgeladen am

18 gennaio 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Inflammatory Tissue Disorder NCT00765362

Englisch

Eligibility Inflammatory Tissue Disorder NCT00765362

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
skeletal maturity
Beschreibung

skeletal maturity

Datentyp

boolean

Alias
UMLS CUI [1]
C3825673
less than 70 on preoperative knee society score (rating score)
Beschreibung

knee score

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022745
UMLS CUI [1,2]
C0449820
sufficient bone stock, as judged by radiographs, to support primary knee implant
Beschreibung

radiograph

Datentyp

boolean

Alias
UMLS CUI [1]
C1962945
patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles
Beschreibung

patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles

Datentyp

boolean

Alias
UMLS CUI [1]
C2076593
UMLS CUI [2]
C0003864
UMLS CUI [3]
C0027543
patient is not pregnant
Beschreibung

pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
primary total knee replacement
Beschreibung

total knee replacement

Datentyp

boolean

Alias
UMLS CUI [1]
C0408406
sufficient collateral ligaments to support device, as judged by physician during stability testing (varus/valgus and flexion/extension)
Beschreibung

collateral ligaments

Datentyp

boolean

Alias
UMLS CUI [1]
C0449054
varus deformity <45 or valgus deformity <45 or fixed flexion deformity <90
Beschreibung

deformities

Datentyp

boolean

Alias
UMLS CUI [1]
C0432593
UMLS CUI [2]
C0042282
UMLS CUI [3]
C0559382
patient is likely to be available for evaluation for the duration of the study
Beschreibung

compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
able and willing to sign the informed consent and follow study procedures
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
skeletal immaturity
Beschreibung

skeletal immaturity

Datentyp

boolean

Alias
UMLS CUI [1]
C3825673
greater than or equal to 70 on preoperative knee society score (rating scale)
Beschreibung

knee score

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022745
UMLS CUI [1,2]
C0449820
previous knee surgery that has adversely affected bone stock or prior total knee replacement
Beschreibung

knee surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0187769
post patellectomy
Beschreibung

patellectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0187898
patient is pregnant
Beschreibung

pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
insufficient collateral ligaments, as judged by the physician
Beschreibung

collateral ligaments

Datentyp

boolean

Alias
UMLS CUI [1]
C0449054
neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as parkinson's disease, multiple sclerosis, previous stroke which affects lower extremity).
Beschreibung

neurologic disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
varus deformity >45 or valgus deformity >45 or fixed flexion deformity >90.
Beschreibung

deformities

Datentyp

boolean

Alias
UMLS CUI [1]
C0432593
UMLS CUI [2]
C0042282
UMLS CUI [3]
C0559382
mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere the with patient's cognitive abilities, senile dementia, and alzheimer's disease).
Beschreibung

comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0021430
prisoners
Beschreibung

prisoner

Datentyp

boolean

Alias
UMLS CUI [1]
C0033167
conditions that place excessive demand on the implant (i.e. charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
Beschreibung

comorbidity, compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C1321605
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Ähnliche Modelle

Eligibility Inflammatory Tissue Disorder NCT00765362

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
skeletal maturity
Item
skeletal maturity
boolean
C3825673 (UMLS CUI [1])
knee score
Item
less than 70 on preoperative knee society score (rating score)
boolean
C0022745 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
radiograph
Item
sufficient bone stock, as judged by radiographs, to support primary knee implant
boolean
C1962945 (UMLS CUI [1])
patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles
Item
patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles
boolean
C2076593 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
C0027543 (UMLS CUI [3])
pregnancy
Item
patient is not pregnant
boolean
C0032961 (UMLS CUI [1])
total knee replacement
Item
primary total knee replacement
boolean
C0408406 (UMLS CUI [1])
collateral ligaments
Item
sufficient collateral ligaments to support device, as judged by physician during stability testing (varus/valgus and flexion/extension)
boolean
C0449054 (UMLS CUI [1])
deformities
Item
varus deformity <45 or valgus deformity <45 or fixed flexion deformity <90
boolean
C0432593 (UMLS CUI [1])
C0042282 (UMLS CUI [2])
C0559382 (UMLS CUI [3])
compliance
Item
patient is likely to be available for evaluation for the duration of the study
boolean
C1321605 (UMLS CUI [1])
informed consent
Item
able and willing to sign the informed consent and follow study procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
skeletal immaturity
Item
skeletal immaturity
boolean
C3825673 (UMLS CUI [1])
knee score
Item
greater than or equal to 70 on preoperative knee society score (rating scale)
boolean
C0022745 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
knee surgery
Item
previous knee surgery that has adversely affected bone stock or prior total knee replacement
boolean
C0187769 (UMLS CUI [1])
patellectomy
Item
post patellectomy
boolean
C0187898 (UMLS CUI [1])
pregnancy
Item
patient is pregnant
boolean
C0032961 (UMLS CUI [1])
collateral ligaments
Item
insufficient collateral ligaments, as judged by the physician
boolean
C0449054 (UMLS CUI [1])
neurologic disorder
Item
neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as parkinson's disease, multiple sclerosis, previous stroke which affects lower extremity).
boolean
C0027765 (UMLS CUI [1])
deformities
Item
varus deformity >45 or valgus deformity >45 or fixed flexion deformity >90.
boolean
C0432593 (UMLS CUI [1])
C0042282 (UMLS CUI [2])
C0559382 (UMLS CUI [3])
comorbidity
Item
mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere the with patient's cognitive abilities, senile dementia, and alzheimer's disease).
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
prisoner
Item
prisoners
boolean
C0033167 (UMLS CUI [1])
comorbidity, compliance
Item
conditions that place excessive demand on the implant (i.e. charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
boolean
C0009488 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
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