ID

31263

Description

Comparing X-3 To N2vac Polyethylene With the Triathlon Total Knee System; ODM derived from: https://clinicaltrials.gov/show/NCT00665964

Link

https://clinicaltrials.gov/show/NCT00665964

Keywords

Versions (1)
  1. 8/5/18 8/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 5, 2018

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.

Back to model comments
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 NCT00665964

English

Eligibility Osteoarthritis NCT00665964

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the subject requires a primary cemented total knee replacement.
Description

Patient need for Primary cemented total knee replacement

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0408401
the subject has a diagnosis of osteoarthritis (oa), traumatic arthritis (ta), or avascular necrosis (avn).
Description

Osteoarthritis | Traumatic arthritis | Avascular necrosis

Data type

boolean

Alias
UMLS CUI [1]
C0029408
UMLS CUI [2]
C0152086
UMLS CUI [3]
C3887513
the subject has intact collateral ligaments.
Description

Collateral ligaments Intact

Data type

boolean

Alias
UMLS CUI [1,1]
C0206365
UMLS CUI [1,2]
C0205266
the subject has signed the ethic committee approved, study specific informed patient consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
the subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
Description

Compliance behavior Evaluation Postoperative | Compliance behavior Postoperative rehabilitation

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C0032790
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0877071
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has inflammatory arthritis.
Description

Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003864
the subject is morbidly obese, bmi > 40.
Description

Obesity, Morbid | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0028756
UMLS CUI [2]
C1305855
the subject has a history of total or unicompartmental reconstruction of the affected joint.
Description

Arthroplasty Total Joint Affected | Arthroplasty Compartment Joint Affected

Data type

boolean

Alias
UMLS CUI [1,1]
C0003893
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0022417
UMLS CUI [1,4]
C0392760
UMLS CUI [2,1]
C0003893
UMLS CUI [2,2]
C1185625
UMLS CUI [2,3]
C0022417
UMLS CUI [2,4]
C0392760
the subject has had a high tibial osteotomy or femoral osteotomy.
Description

Osteotomy of proximal tibia | Osteotomy Femoral

Data type

boolean

Alias
UMLS CUI [1]
C0407484
UMLS CUI [2,1]
C0029468
UMLS CUI [2,2]
C0015811
the subject has a neuromuscular or neurosensory deficiency, that would limit the ability to assess the performance of the device.
Description

Neuromuscular impairment | Neurosensory impairment | Assessment Performance Device Limited

Data type

boolean

Alias
UMLS CUI [1]
C4062805
UMLS CUI [2]
C4062958
UMLS CUI [3,1]
C1516048
UMLS CUI [3,2]
C1882330
UMLS CUI [3,3]
C0025080
UMLS CUI [3,4]
C0439801
the subject has a systemic or metabolic disorder leading to progressive bone deterioration.
Description

Systemic disease Resulting in Bone deterioration | Metabolic Disease Resulting in Bone deterioration

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0262950
UMLS CUI [1,4]
C0868945
UMLS CUI [2,1]
C0025517
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0262950
UMLS CUI [2,4]
C0868945
the subject is immunologically suppressed, or receiving chronic steroids (>30 days duration).
Description

Therapeutic immunosuppression | Steroids chronic

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0205191
the subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
Description

Bone Impaired Due to Disease | Bone Impaired Due to Communicable Disease | Prosthesis Support Inadequate | Prosthesis Fixation Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0012634
UMLS CUI [2,1]
C0262950
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0009450
UMLS CUI [3,1]
C0175649
UMLS CUI [3,2]
C1521721
UMLS CUI [3,3]
C0205412
UMLS CUI [4,1]
C3178966
UMLS CUI [4,2]
C0205412
the subject has had a knee fusion at the affected joint.
Description

Arthrodesis of knee Joint Affected

Data type

boolean

Alias
UMLS CUI [1,1]
C0188172
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C0392760
the subject has an active or suspected latent infection in or about the knee joint.
Description

Latent infection Knee joint | Latent infection Suspected Knee joint

Data type

boolean

Alias
UMLS CUI [1,1]
C0872054
UMLS CUI [1,2]
C0022745
UMLS CUI [2,1]
C0872054
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0022745
the subject is a prisoner.
Description

Prisoner

Data type

boolean

Alias
UMLS CUI [1]
C0033167
Back to the top of the page

Similar models

Eligibility Osteoarthritis NCT00665964

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient need for Primary cemented total knee replacement
Item
the subject requires a primary cemented total knee replacement.
boolean
C0686904 (UMLS CUI [1,1])
C0408401 (UMLS CUI [1,2])
Osteoarthritis | Traumatic arthritis | Avascular necrosis
Item
the subject has a diagnosis of osteoarthritis (oa), traumatic arthritis (ta), or avascular necrosis (avn).
boolean
C0029408 (UMLS CUI [1])
C0152086 (UMLS CUI [2])
C3887513 (UMLS CUI [3])
Collateral ligaments Intact
Item
the subject has intact collateral ligaments.
boolean
C0206365 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
Informed Consent
Item
the subject has signed the ethic committee approved, study specific informed patient consent form.
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Evaluation Postoperative | Compliance behavior Postoperative rehabilitation
Item
the subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
boolean
C1321605 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0877071 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Arthritis
Item
the subject has inflammatory arthritis.
boolean
C0003864 (UMLS CUI [1])
Obesity, Morbid | Body mass index
Item
the subject is morbidly obese, bmi > 40.
boolean
C0028756 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Arthroplasty Total Joint Affected | Arthroplasty Compartment Joint Affected
Item
the subject has a history of total or unicompartmental reconstruction of the affected joint.
boolean
C0003893 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0003893 (UMLS CUI [2,1])
C1185625 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
C0392760 (UMLS CUI [2,4])
Osteotomy of proximal tibia | Osteotomy Femoral
Item
the subject has had a high tibial osteotomy or femoral osteotomy.
boolean
C0407484 (UMLS CUI [1])
C0029468 (UMLS CUI [2,1])
C0015811 (UMLS CUI [2,2])
Neuromuscular impairment | Neurosensory impairment | Assessment Performance Device Limited
Item
the subject has a neuromuscular or neurosensory deficiency, that would limit the ability to assess the performance of the device.
boolean
C4062805 (UMLS CUI [1])
C4062958 (UMLS CUI [2])
C1516048 (UMLS CUI [3,1])
C1882330 (UMLS CUI [3,2])
C0025080 (UMLS CUI [3,3])
C0439801 (UMLS CUI [3,4])
Systemic disease Resulting in Bone deterioration | Metabolic Disease Resulting in Bone deterioration
Item
the subject has a systemic or metabolic disorder leading to progressive bone deterioration.
boolean
C0442893 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0262950 (UMLS CUI [1,3])
C0868945 (UMLS CUI [1,4])
C0025517 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0262950 (UMLS CUI [2,3])
C0868945 (UMLS CUI [2,4])
Therapeutic immunosuppression | Steroids chronic
Item
the subject is immunologically suppressed, or receiving chronic steroids (>30 days duration).
boolean
C0021079 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Bone Impaired Due to Disease | Bone Impaired Due to Communicable Disease | Prosthesis Support Inadequate | Prosthesis Fixation Inadequate
Item
the subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
boolean
C0262950 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C0262950 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0009450 (UMLS CUI [2,4])
C0175649 (UMLS CUI [3,1])
C1521721 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
C3178966 (UMLS CUI [4,1])
C0205412 (UMLS CUI [4,2])
Arthrodesis of knee Joint Affected
Item
the subject has had a knee fusion at the affected joint.
boolean
C0188172 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
Latent infection Knee joint | Latent infection Suspected Knee joint
Item
the subject has an active or suspected latent infection in or about the knee joint.
boolean
C0872054 (UMLS CUI [1,1])
C0022745 (UMLS CUI [1,2])
C0872054 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0022745 (UMLS CUI [2,3])
Prisoner
Item
the subject is a prisoner.
boolean
C0033167 (UMLS CUI [1])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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