ID

31857

Description

3DKnee™ System vs. the MJS Knee System; ODM derived from: https://clinicaltrials.gov/show/NCT00764803

Link

https://clinicaltrials.gov/show/NCT00764803

Keywords

Versions (1)
  1. 10/4/18 10/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00764803

English

Eligibility Rheumatoid Arthritis NCT00764803

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
this must be a primary knee replacement on this knee.
Description

Knee Replacement Primary | Knee Involved

Data type

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0022742
UMLS CUI [2,2]
C1314939
patient is over 18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must have one of the following
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
rheumatoid or traumatic arthritis or
Description

Rheumatoid Arthritis | Traumatic arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0152086
joint disease secondary to osteoarthritis
Description

Joint disease Secondary to Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0022408
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0029408
patient is likely to be available for evaluation for the duration of the study
Description

Patient Available Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0220825
able and willing to sign the informed consent and follow study procedures
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient is not pregnant
Description

Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
is younger than 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
if there has been a total knee replacement on this knee in the past (no revisions allowed in study)
Description

Total knee replacement In the past | Knee Involved

Data type

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C1444637
UMLS CUI [2,1]
C0022742
UMLS CUI [2,2]
C1314939
overt infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
alcoholism or other addictions
Description

Alcoholic Intoxication, Chronic | Addictive Behavior

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0085281
muscular, neurological or vascular deficiencies which compromise the affected extremity
Description

Deficiency Muscular | Deficiency Neurological | Vascular deficiency | Risk factors Extremity Affected

Data type

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]
C0035648
UMLS CUI [4,2]
C0015385
UMLS CUI [4,3]
C0392760
obesity
Description

Obesity

Data type

boolean

Alias
UMLS CUI [1]
C0028754
marked bone loss
Description

Bone loss Marked

Data type

boolean

Alias
UMLS CUI [1,1]
C0029453
UMLS CUI [1,2]
C1706089
materials sensitivity
Description

Hypersensitivity Materials

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0520510
prisoner
Description

Prisoner

Data type

boolean

Alias
UMLS CUI [1]
C0033167
mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
Description

Mental condition Interferes with Informed Consent | Mental condition Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
patient is pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Rheumatoid Arthritis NCT00764803

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Knee Replacement Primary | Knee Involved
Item
this must be a primary knee replacement on this knee.
boolean
C0086511 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0022742 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
Age
Item
patient is over 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Criteria Fulfill
Item
patients must have one of the following
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Rheumatoid Arthritis | Traumatic arthritis
Item
rheumatoid or traumatic arthritis or
boolean
C0003873 (UMLS CUI [1])
C0152086 (UMLS CUI [2])
Joint disease Secondary to Osteoarthritis
Item
joint disease secondary to osteoarthritis
boolean
C0022408 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
Patient Available Evaluation
Item
patient is likely to be available for evaluation for the duration of the study
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Informed Consent
Item
able and willing to sign the informed consent and follow study procedures
boolean
C0021430 (UMLS CUI [1])
Pregnancy Absent
Item
patient is not pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
is younger than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Total knee replacement In the past | Knee Involved
Item
if there has been a total knee replacement on this knee in the past (no revisions allowed in study)
boolean
C0086511 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0022742 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
Communicable Disease
Item
overt infection
boolean
C0009450 (UMLS CUI [1])
Alcoholic Intoxication, Chronic | Addictive Behavior
Item
alcoholism or other addictions
boolean
C0001973 (UMLS CUI [1])
C0085281 (UMLS CUI [2])
Deficiency Muscular | Deficiency Neurological | Vascular deficiency | Risk factors Extremity Affected
Item
muscular, neurological or vascular deficiencies which 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])
C0035648 (UMLS CUI [4,1])
C0015385 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
Obesity
Item
obesity
boolean
C0028754 (UMLS CUI [1])
Bone loss Marked
Item
marked bone loss
boolean
C0029453 (UMLS CUI [1,1])
C1706089 (UMLS CUI [1,2])
Hypersensitivity Materials
Item
materials sensitivity
boolean
C0020517 (UMLS CUI [1,1])
C0520510 (UMLS CUI [1,2])
Prisoner
Item
prisoner
boolean
C0033167 (UMLS CUI [1])
Mental condition Interferes with Informed Consent | Mental condition Interferes with Protocol Compliance
Item
mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Pregnancy
Item
patient is pregnant
boolean
C0032961 (UMLS CUI [1])
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