ID

36720

Descrição

Prospective Functional Outcome Study of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT02079493

Link

https://clinicaltrials.gov/show/NCT02079493

Palavras-chave

Versões (1)
  1. 04/06/2019 04/06/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de junho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Knee NCT02079493

Inglês

Eligibility Osteoarthritis of the Knee NCT02079493

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is a male or non-pregnant female age 55 years or older at time of study
Descrição

Gender | Gender Pregnancy Absent | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0001779
patient is a candidate for a total knee arthroplasty
Descrição

Patient Appropriate Total Knee Arthroplasty

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0086511
patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients younger than 55 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopaedic surgeon
Descrição

Principal diagnosis | Exception Knee Osteoarthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0332137
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0409959
patients who have had any previous lower extremity procedure
Descrição

Procedure on lower extremity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1292889
patients with a bmi greater than or equal to 40
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
patients with an active infection within the affected knee joint patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
Descrição

Communicable Disease Knee joint affected | Deficiency Neuromuscular | Neurosensory impairment | Evaluation procedure Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0022745
UMLS CUI [1,3]
C1314939
UMLS CUI [2,1]
C0011155
UMLS CUI [2,2]
C1979768
UMLS CUI [3]
C4062958
UMLS CUI [4,1]
C1261322
UMLS CUI [4,2]
C0439801
patient is diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. lupus erythematosus, paget's disease)
Descrição

Systemic disease | Metabolic Disease | Etiology Bone deterioration Progressive | Lupus Erythematosus | Paget Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2]
C0025517
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0262950
UMLS CUI [3,3]
C0868945
UMLS CUI [3,4]
C0205329
UMLS CUI [4]
C0409974
UMLS CUI [5]
C1368019
patient is immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
Descrição

Immunosuppression | Steroids Excessive chronic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0442802
UMLS CUI [2,3]
C0205191
patient has a known sensitivity to device materials
Descrição

Device allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3544351
non-english speaking patients
Descrição

Lacking Able to speak English Language

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
patient is a prisoner
Descrição

Prisoners

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033167
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Similar models

Eligibility Osteoarthritis of the Knee NCT02079493

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Gender Pregnancy Absent | Age
Item
patient is a male or non-pregnant female age 55 years or older at time of study
boolean
C0079399 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
Patient Appropriate Total Knee Arthroplasty
Item
patient is a candidate for a total knee arthroplasty
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0086511 (UMLS CUI [1,3])
Protocol Compliance
Item
patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients younger than 55 years of age
boolean
C0001779 (UMLS CUI [1])
Principal diagnosis | Exception Knee Osteoarthritis
Item
patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopaedic surgeon
boolean
C0332137 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0409959 (UMLS CUI [2,2])
Procedure on lower extremity
Item
patients who have had any previous lower extremity procedure
boolean
C1292889 (UMLS CUI [1])
Body mass index
Item
patients with a bmi greater than or equal to 40
boolean
C1305855 (UMLS CUI [1])
Communicable Disease Knee joint affected | Deficiency Neuromuscular | Neurosensory impairment | Evaluation procedure Limited
Item
patients with an active infection within the affected knee joint patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
boolean
C0009450 (UMLS CUI [1,1])
C0022745 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0011155 (UMLS CUI [2,1])
C1979768 (UMLS CUI [2,2])
C4062958 (UMLS CUI [3])
C1261322 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
Systemic disease | Metabolic Disease | Etiology Bone deterioration Progressive | Lupus Erythematosus | Paget Disease
Item
patient is diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. lupus erythematosus, paget's disease)
boolean
C0442893 (UMLS CUI [1])
C0025517 (UMLS CUI [2])
C0015127 (UMLS CUI [3,1])
C0262950 (UMLS CUI [3,2])
C0868945 (UMLS CUI [3,3])
C0205329 (UMLS CUI [3,4])
C0409974 (UMLS CUI [4])
C1368019 (UMLS CUI [5])
Immunosuppression | Steroids Excessive chronic
Item
patient is immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
boolean
C4048329 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Device allergy
Item
patient has a known sensitivity to device materials
boolean
C3544351 (UMLS CUI [1])
Lacking Able to speak English Language
Item
non-english speaking patients
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Prisoners
Item
patient is a prisoner
boolean
C0033167 (UMLS CUI [1])
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