ID

13127

Description

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

Link

https://clinicaltrials.gov/show/NCT00765362

Keywords

Versions (1)
  1. 1/18/16 1/18/16 -
Uploaded on

January 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Inflammatory Tissue Disorder NCT00765362

English

Eligibility Inflammatory Tissue Disorder NCT00765362

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
skeletal maturity
Description

skeletal maturity

Data type

boolean

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

knee score

Data type

boolean

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

radiograph

Data type

boolean

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

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

Data type

boolean

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

pregnancy

Data type

boolean

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

total knee replacement

Data type

boolean

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

collateral ligaments

Data type

boolean

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

deformities

Data type

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
Description

compliance

Data type

boolean

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

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
skeletal immaturity
Description

skeletal immaturity

Data type

boolean

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

knee score

Data type

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
Description

knee surgery

Data type

boolean

Alias
UMLS CUI [1]
C0187769
post patellectomy
Description

patellectomy

Data type

boolean

Alias
UMLS CUI [1]
C0187898
patient is pregnant
Description

pregnancy

Data type

boolean

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

collateral ligaments

Data type

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).
Description

neurologic disorder

Data type

boolean

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

deformities

Data type

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).
Description

comorbidity

Data type

boolean

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

prisoner

Data type

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).
Description

comorbidity, compliance

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C1321605
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Similar models

Eligibility Inflammatory Tissue Disorder NCT00765362

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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