ID

31259

Description

Roentgen Stereophotogrammetric Analysis (RSA) to Evaluate Fixation of Biofoam Advance Total Knee Arthroplasty Components; ODM derived from: https://clinicaltrials.gov/show/NCT00657956

Link

https://clinicaltrials.gov/show/NCT00657956

Keywords

Versions (1)
  1. 8/4/18 8/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00657956

English

Eligibility Osteoarthritis NCT00657956

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic osteoarthritis of the knee indicating surgical intervention
Description

Knee Osteoarthritis Symptomatic | Indication Surgical intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0549433
between the ages of 21 and 80 inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ability to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant co-morbidity affecting ability to ambulate
Description

Comorbidity Affecting Ability to walk

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0559964
flexion contracture greater than 15°
Description

Flexion contracture

Data type

boolean

Alias
UMLS CUI [1]
C0333068
extension lag greater than 10°
Description

Extension lag

Data type

boolean

Alias
UMLS CUI [1]
C0231746
tibial subluxation greater than 10 mm on standing ap radiograph
Description

Subluxation tibial Radiologic examination of knee, standing anteroposterior

Data type

boolean

Alias
UMLS CUI [1,1]
C0332768
UMLS CUI [1,2]
C0040184
UMLS CUI [1,3]
C0203276
prior arthroplasty, patellectomy or osteotomy with the affected knee
Description

Arthroplasty Knee Affected | Patellectomy Knee Affected | Osteotomy Knee Affected

Data type

boolean

Alias
UMLS CUI [1,1]
C0003893
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0392760
UMLS CUI [2,1]
C0187898
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C0392760
UMLS CUI [3,1]
C0029468
UMLS CUI [3,2]
C0022742
UMLS CUI [3,3]
C0392760
lateral or medial collateral ligament instability (> 10° varus/valgus)
Description

Genu varum Collateral ligament Lateral Unstable | Genu varum Collateral ligament Medial Unstable | Genu valgum Collateral ligament Lateral Unstable | Genu valgum Collateral ligament Medial Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0544755
UMLS CUI [1,2]
C0206365
UMLS CUI [1,3]
C0205093
UMLS CUI [1,4]
C0443343
UMLS CUI [2,1]
C0544755
UMLS CUI [2,2]
C0206365
UMLS CUI [2,3]
C0205098
UMLS CUI [2,4]
C0443343
UMLS CUI [3,1]
C0576093
UMLS CUI [3,2]
C0206365
UMLS CUI [3,3]
C0205093
UMLS CUI [3,4]
C0443343
UMLS CUI [4,1]
C0576093
UMLS CUI [4,2]
C0206365
UMLS CUI [4,3]
C0205098
UMLS CUI [4,4]
C0443343
leg length discrepancy greater than 10 mm
Description

Leg Length Inequality

Data type

boolean

Alias
UMLS CUI [1]
C0023221
active or prior infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
morbid obesity (bmi > 40)
Description

Obesity, Morbid | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0028756
UMLS CUI [2]
C1305855
medical condition precluding major surgery
Description

Medical condition Excludes Major surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0679637
severe osteoporosis or osteopenia
Description

Severe osteoporosis | Severe osteopenia

Data type

boolean

Alias
UMLS CUI [1]
C1859443
UMLS CUI [2]
C1970459
neuromuscular impairment
Description

Neuromuscular impairment

Data type

boolean

Alias
UMLS CUI [1]
C4062805
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Similar models

Eligibility Osteoarthritis NCT00657956

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Knee Osteoarthritis Symptomatic | Indication Surgical intervention
Item
symptomatic osteoarthritis of the knee indicating surgical intervention
boolean
C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0549433 (UMLS CUI [2,2])
Age
Item
between the ages of 21 and 80 inclusive
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
ability to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity Affecting Ability to walk
Item
significant co-morbidity affecting ability to ambulate
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0559964 (UMLS CUI [1,3])
Flexion contracture
Item
flexion contracture greater than 15°
boolean
C0333068 (UMLS CUI [1])
Extension lag
Item
extension lag greater than 10°
boolean
C0231746 (UMLS CUI [1])
Subluxation tibial Radiologic examination of knee, standing anteroposterior
Item
tibial subluxation greater than 10 mm on standing ap radiograph
boolean
C0332768 (UMLS CUI [1,1])
C0040184 (UMLS CUI [1,2])
C0203276 (UMLS CUI [1,3])
Arthroplasty Knee Affected | Patellectomy Knee Affected | Osteotomy Knee Affected
Item
prior arthroplasty, patellectomy or osteotomy with the affected knee
boolean
C0003893 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0187898 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0029468 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
Genu varum Collateral ligament Lateral Unstable | Genu varum Collateral ligament Medial Unstable | Genu valgum Collateral ligament Lateral Unstable | Genu valgum Collateral ligament Medial Unstable
Item
lateral or medial collateral ligament instability (> 10° varus/valgus)
boolean
C0544755 (UMLS CUI [1,1])
C0206365 (UMLS CUI [1,2])
C0205093 (UMLS CUI [1,3])
C0443343 (UMLS CUI [1,4])
C0544755 (UMLS CUI [2,1])
C0206365 (UMLS CUI [2,2])
C0205098 (UMLS CUI [2,3])
C0443343 (UMLS CUI [2,4])
C0576093 (UMLS CUI [3,1])
C0206365 (UMLS CUI [3,2])
C0205093 (UMLS CUI [3,3])
C0443343 (UMLS CUI [3,4])
C0576093 (UMLS CUI [4,1])
C0206365 (UMLS CUI [4,2])
C0205098 (UMLS CUI [4,3])
C0443343 (UMLS CUI [4,4])
Leg Length Inequality
Item
leg length discrepancy greater than 10 mm
boolean
C0023221 (UMLS CUI [1])
Communicable Disease
Item
active or prior infection
boolean
C0009450 (UMLS CUI [1])
Obesity, Morbid | Body mass index
Item
morbid obesity (bmi > 40)
boolean
C0028756 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Medical condition Excludes Major surgery
Item
medical condition precluding major surgery
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0679637 (UMLS CUI [1,3])
Severe osteoporosis | Severe osteopenia
Item
severe osteoporosis or osteopenia
boolean
C1859443 (UMLS CUI [1])
C1970459 (UMLS CUI [2])
Neuromuscular impairment
Item
neuromuscular impairment
boolean
C4062805 (UMLS CUI [1])
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