ID

43035

Description

Knee Bracing for People With Patellofemoral Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00381563

Link

https://clinicaltrials.gov/show/NCT00381563

Keywords

Versions (2)
  1. 4/13/17 4/13/17 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT00381563

English

Eligibility Knee Osteoarthritis NCT00381563

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
knee pain on most days
Description

Knee pain Most days

Data type

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C3840699
either isolated patellofemoral osteoarthritis or mixed patellofemoral and tibiofemoral osteoarthritis, as based on x-ray
Description

Patellofemoral osteoarthritis Isolated roentgenographic | Patellofemoral osteoarthritis roentgenographic | Degenerative polyarthritis Knee joint roentgenographic

Data type

boolean

Alias
UMLS CUI [1,1]
C1542808
UMLS CUI [1,2]
C0205409
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C1542808
UMLS CUI [2,2]
C0034571
UMLS CUI [3,1]
C0029408
UMLS CUI [3,2]
C0022745
UMLS CUI [3,3]
C0034571
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bed- or chair-bound, usually uses an ambulation aid to walk (e.g., cane, crutch, or walker), or uses a wheelchair
Description

Bed-ridden | Confined to chair | ambulation with walking aid | Cane user | Crutch | Walker | wheelchair

Data type

boolean

Alias
UMLS CUI [1]
C0425251
UMLS CUI [2]
C0425250
UMLS CUI [3]
C3695267
UMLS CUI [4]
C0920240
UMLS CUI [5]
C0010397
UMLS CUI [6]
C0043016
UMLS CUI [7]
C0043143
pain emanating more from the back or hip than from the knee, as determined by screening questionnaire
Description

Back Pain | Hip pain | screening questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C0004604
UMLS CUI [2]
C0019559
UMLS CUI [3]
C1134635
low pain score on the visual analog scale (vas) (less than 4 out of 10)
Description

Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1]
C0042815
plans to move from the area within 10 months of study screening
Description

Relocation of home Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
symptomatic comorbid disease that limits activities more than knee pain does, as determined by screening questionnaire (e.g., congestive heart failure, chronic obstructive pulmonary disease)
Description

Comorbidity Symptomatic | Physical activity Limited | screening questionnaire | Congestive heart failure | Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C0439801
UMLS CUI [3]
C1134635
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0024117
receiving corticosteroid injections in the month before study entry, or receiving hyaluronan in the 6-month period before study entry. no other treatments will result in exclusion, although for patients taking glucosamine and/or chondroitin and/or a non-steroidal anti-inflammatory drug (nsaid), they must have taken these treatments for at least 2 months before study entry and must commit to not start a new treatment during the study.
Description

Adrenal Cortex Hormones Injection | Hyaluronan | Glucosamine | Chondroitin | Anti-Inflammatory Agents, Non-Steroidal

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1828121
UMLS CUI [2]
C0020196
UMLS CUI [3]
C0017718
UMLS CUI [4]
C0008454
UMLS CUI [5]
C0003211
bilateral total knee replacements or plans for a total knee replacement of the affected knee in the next 6 months
Description

Knee Replacement Total Bilateral | Knee Replacement Total Planned | Knee Involved

Data type

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0238767
UMLS CUI [2,1]
C0086511
UMLS CUI [2,2]
C0439810
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0022742
UMLS CUI [3,2]
C1314939
morbidly obese (body mass index greater than 35), as brace fitting and prevention of slippage of the brace will be difficult
Description

Morbid Obesity Body mass index | Brace Fitting Difficult

Data type

boolean

Alias
UMLS CUI [1,1]
C0028756
UMLS CUI [1,2]
C1305855
UMLS CUI [2,1]
C0696595
UMLS CUI [2,2]
C0441548
UMLS CUI [2,3]
C0332218
known other causes of arthritis, including rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, and pseudogout
Description

Arthritis causes | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Gout | Arthritis, Psoriatic | Pseudogout

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0015127
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0018099
UMLS CUI [5]
C0003872
UMLS CUI [6]
C0033802
skin breakdown at the site where the brace will be applied
Description

Broken skin Site Brace Apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0150077
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0696595
UMLS CUI [1,4]
C4048755
failure to pass the run-in test, or the brace falls down the leg during the run-in
Description

Run-in Test failed

Data type

boolean

Alias
UMLS CUI [1,1]
C3274438
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0231175
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Similar models

Eligibility Knee Osteoarthritis NCT00381563

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Knee pain Most days
Item
knee pain on most days
boolean
C0231749 (UMLS CUI [1,1])
C3840699 (UMLS CUI [1,2])
Patellofemoral osteoarthritis Isolated roentgenographic | Patellofemoral osteoarthritis roentgenographic | Degenerative polyarthritis Knee joint roentgenographic
Item
either isolated patellofemoral osteoarthritis or mixed patellofemoral and tibiofemoral osteoarthritis, as based on x-ray
boolean
C1542808 (UMLS CUI [1,1])
C0205409 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C1542808 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
C0029408 (UMLS CUI [3,1])
C0022745 (UMLS CUI [3,2])
C0034571 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Bed-ridden | Confined to chair | ambulation with walking aid | Cane user | Crutch | Walker | wheelchair
Item
bed- or chair-bound, usually uses an ambulation aid to walk (e.g., cane, crutch, or walker), or uses a wheelchair
boolean
C0425251 (UMLS CUI [1])
C0425250 (UMLS CUI [2])
C3695267 (UMLS CUI [3])
C0920240 (UMLS CUI [4])
C0010397 (UMLS CUI [5])
C0043016 (UMLS CUI [6])
C0043143 (UMLS CUI [7])
Back Pain | Hip pain | screening questionnaire
Item
pain emanating more from the back or hip than from the knee, as determined by screening questionnaire
boolean
C0004604 (UMLS CUI [1])
C0019559 (UMLS CUI [2])
C1134635 (UMLS CUI [3])
Visual Analog Pain Scale
Item
low pain score on the visual analog scale (vas) (less than 4 out of 10)
boolean
C0042815 (UMLS CUI [1])
Relocation of home Planned
Item
plans to move from the area within 10 months of study screening
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Comorbidity Symptomatic | Physical activity Limited | screening questionnaire | Congestive heart failure | Chronic Obstructive Airway Disease
Item
symptomatic comorbid disease that limits activities more than knee pain does, as determined by screening questionnaire (e.g., congestive heart failure, chronic obstructive pulmonary disease)
boolean
C0009488 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0026606 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C1134635 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0024117 (UMLS CUI [5])
Adrenal Cortex Hormones Injection | Hyaluronan | Glucosamine | Chondroitin | Anti-Inflammatory Agents, Non-Steroidal
Item
receiving corticosteroid injections in the month before study entry, or receiving hyaluronan in the 6-month period before study entry. no other treatments will result in exclusion, although for patients taking glucosamine and/or chondroitin and/or a non-steroidal anti-inflammatory drug (nsaid), they must have taken these treatments for at least 2 months before study entry and must commit to not start a new treatment during the study.
boolean
C0001617 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0020196 (UMLS CUI [2])
C0017718 (UMLS CUI [3])
C0008454 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
Knee Replacement Total Bilateral | Knee Replacement Total Planned | Knee Involved
Item
bilateral total knee replacements or plans for a total knee replacement of the affected knee in the next 6 months
boolean
C0086511 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
C0086511 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0022742 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
Morbid Obesity Body mass index | Brace Fitting Difficult
Item
morbidly obese (body mass index greater than 35), as brace fitting and prevention of slippage of the brace will be difficult
boolean
C0028756 (UMLS CUI [1,1])
C1305855 (UMLS CUI [1,2])
C0696595 (UMLS CUI [2,1])
C0441548 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Arthritis causes | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Gout | Arthritis, Psoriatic | Pseudogout
Item
known other causes of arthritis, including rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, and pseudogout
boolean
C0003864 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
C0018099 (UMLS CUI [4])
C0003872 (UMLS CUI [5])
C0033802 (UMLS CUI [6])
Broken skin Site Brace Apply
Item
skin breakdown at the site where the brace will be applied
boolean
C0150077 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0696595 (UMLS CUI [1,3])
C4048755 (UMLS CUI [1,4])
Run-in Test failed
Item
failure to pass the run-in test, or the brace falls down the leg during the run-in
boolean
C3274438 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
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