ID

20285

Description

Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00586781

Link

https://clinicaltrials.gov/show/NCT00586781

Keywords

Versions (1)
  1. 2/19/17 2/19/17 -
Uploaded on

February 19, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00586781

English

Eligibility Osteoarthritis NCT00586781

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
moderate or severe pain, loss of mobility and function of the ankle
Description

pain, mobility and function of ankle

Data type

boolean

Alias
UMLS CUI [1]
C0030193
UMLS CUI [2]
C1820723
UMLS CUI [3]
C1535551
primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
Description

primary arthrosis

Data type

boolean

Alias
UMLS CUI [1]
C1388735
UMLS CUI [2]
C1388734
UMLS CUI [3,1]
C0029408
UMLS CUI [3,2]
C0857204
at least six months of conservative treatment for severe ankle conditions
Description

conservative treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0459914
UMLS CUI [1,2]
C0182986
bilateral ankle disease that have not been enrolled in the pivotal study or single ankle disease and enrolled in the pivotal study but have subsequently developed ankle disease in the contralateral ankle and require surgical intervention
Description

ankle disease

Data type

boolean

Alias
UMLS CUI [1]
C0182986
willing and able to give informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have not reached skeletal maturity
Description

skeletal maturity

Data type

boolean

Alias
UMLS CUI [1]
C3825673
active or prior deep infection in the ankle joint or adjacent bones
Description

ankle infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0851989
UMLS CUI [1,2]
C0003087
prior arthrodesis at the involved site
Description

prior arthrodesis

Data type

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0003881
history of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
Description

ability to follow the study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1321605
obesity (weight greater than 250 lbs)
Description

obesity

Data type

boolean

Alias
UMLS CUI [1]
C0028754
history of current or prior drug abuse or alcoholism
Description

substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
any physical condition precluding major surgery
Description

surgery contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0522473
prior surgery and/or injury that has adversely affected the ankle bone stock
Description

prior surgery affecting ankle bone stock

Data type

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0003087
UMLS CUI [1,4]
C0005962
severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone
Description

contraindication implant fixation

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0188664
insufficient ligament support
Description

insufficient ligament support

Data type

boolean

Alias
UMLS CUI [1,1]
C0231179
UMLS CUI [1,2]
C0023685
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Similar models

Eligibility Osteoarthritis NCT00586781

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
pain, mobility and function of ankle
Item
moderate or severe pain, loss of mobility and function of the ankle
boolean
C0030193 (UMLS CUI [1])
C1820723 (UMLS CUI [2])
C1535551 (UMLS CUI [3])
primary arthrosis
Item
primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
boolean
C1388735 (UMLS CUI [1])
C1388734 (UMLS CUI [2])
C0029408 (UMLS CUI [3,1])
C0857204 (UMLS CUI [3,2])
conservative treatment
Item
at least six months of conservative treatment for severe ankle conditions
boolean
C0459914 (UMLS CUI [1,1])
C0182986 (UMLS CUI [1,2])
ankle disease
Item
bilateral ankle disease that have not been enrolled in the pivotal study or single ankle disease and enrolled in the pivotal study but have subsequently developed ankle disease in the contralateral ankle and require surgical intervention
boolean
C0182986 (UMLS CUI [1])
informed consent
Item
willing and able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
skeletal maturity
Item
patients who have not reached skeletal maturity
boolean
C3825673 (UMLS CUI [1])
ankle infection
Item
active or prior deep infection in the ankle joint or adjacent bones
boolean
C0851989 (UMLS CUI [1,1])
C0003087 (UMLS CUI [1,2])
prior arthrodesis
Item
prior arthrodesis at the involved site
boolean
C0455610 (UMLS CUI [1,1])
C0003881 (UMLS CUI [1,2])
ability to follow the study protocol
Item
history of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
obesity
Item
obesity (weight greater than 250 lbs)
boolean
C0028754 (UMLS CUI [1])
substance abuse
Item
history of current or prior drug abuse or alcoholism
boolean
C0038586 (UMLS CUI [1])
surgery contraindication
Item
any physical condition precluding major surgery
boolean
C0679637 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
prior surgery affecting ankle bone stock
Item
prior surgery and/or injury that has adversely affected the ankle bone stock
boolean
C0455610 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0003087 (UMLS CUI [1,3])
C0005962 (UMLS CUI [1,4])
contraindication implant fixation
Item
severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone
boolean
C0522473 (UMLS CUI [1,1])
C0188664 (UMLS CUI [1,2])
insufficient ligament support
Item
insufficient ligament support
boolean
C0231179 (UMLS CUI [1,1])
C0023685 (UMLS CUI [1,2])
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