ID

36720

Description

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

Link

https://clinicaltrials.gov/show/NCT02079493

Keywords

  1. 6/4/19 6/4/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 4, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Osteoarthritis of the Knee NCT02079493

Eligibility Osteoarthritis of the Knee NCT02079493

Inclusion Criteria
Description

Inclusion Criteria

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

Gender | Gender Pregnancy Absent | Age

Data type

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
Description

Patient Appropriate Total Knee Arthroplasty

Data type

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.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

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

Age

Data type

boolean

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

Principal diagnosis | Exception Knee Osteoarthritis

Data type

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
Description

Procedure on lower extremity

Data type

boolean

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

Body mass index

Data type

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
Description

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

Data type

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)
Description

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

Data type

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)
Description

Immunosuppression | Steroids Excessive chronic

Data type

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
Description

Device allergy

Data type

boolean

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

Lacking Able to speak English Language

Data type

boolean

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

Prisoners

Data type

boolean

Alias
UMLS CUI [1]
C0033167

Similar models

Eligibility Osteoarthritis of the Knee NCT02079493

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

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial