ID

42524

Description

Effect of Interventions on the Progression of Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02178137

Link

https://clinicaltrials.gov/show/NCT02178137

Keywords

Versions (1)
  1. 8/18/21 8/18/21 -
Copyright Holder

Indus Hospital and Health Network

Uploaded on

August 18, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Osteo Arthritis of the Knees NCT02178137

English

Eligibility Osteo Arthritis of the Knees NCT02178137

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients of either sex aged between 40 to 65 years with mild to moderate osteoarthritis of the knees.
Description

Age | Osteoartrhitis mild to moderate

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C2945599
UMLS CUI [3,1]
C0409959
UMLS CUI [3,2]
C0205081
patients should have history of knee pain for at least 6 months and on the majority of days during the preceding month
Description

Knee pain duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0449238
each joint will be scored separately so one patient with bilateral knee osteoarthritis will be counted as 2 knees.
Description

Each joint will be scored separately

Data type

boolean

Alias
UMLS CUI [1,1]
C0022417
UMLS CUI [1,2]
C0443299
UMLS CUI [1,3]
C0205210
UMLS CUI [1,4]
C0449820
UMLS CUI [1,5]
C1265611
the osteoarthritis will be graded on basis of clinical score as well as seen on appropriately positioned x rays using the kellgren and lawrence grading. (tibio femoral osteophytes of at least 1 mm, kellgren lawrence grading of 2 or 3)
Description

Osteoarthritis clinical score | Kellgren and Lawrence grading

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0449820
UMLS CUI [2]
C3177117
patients with diabetes are sent to the diabetes clinic and are included once their hba1c level becomes normal.
Description

Hba1c levels normal in diabetic patients

Data type

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C0241863
patients giving informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with severe end stage tricompartmental osteoarthritis of the knees .
Description

Severe end stage tricompartmental osteoarthritis of the knees

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205088
UMLS CUI [1,4]
C0447798
UMLS CUI [1,5]
C1265611
presence of uncontrolled systemic disease like chronic liver and renal disease
Description

Uncontrolled systemic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205318
patients with diagnosis other than osteoarthritis, such as knee arthritis due to rheumatoid disease, gout, post traumatic arthritis
Description

Diagnosis other than osteoarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C0409959
patients with history of surgery to any knee will have that knee excluded
Description

History of knee surgery in the site of lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0262926
pregnant or lactating mothers
Description

Pregnancy | Breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with chronic anaemia
Description

Chronic anaemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0205191
patients who get an injection in their affected knee
Description

Injection in affected knee

Data type

boolean

Alias
UMLS CUI [1,1]
C1828121
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0392760
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Similar models

Eligibility Osteo Arthritis of the Knees NCT02178137

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Osteoartrhitis mild to moderate
Item
patients of either sex aged between 40 to 65 years with mild to moderate osteoarthritis of the knees.
boolean
C0001779 (UMLS CUI [1])
C0409959 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0409959 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
Knee pain duration
Item
patients should have history of knee pain for at least 6 months and on the majority of days during the preceding month
boolean
C0231749 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Each joint will be scored separately
Item
each joint will be scored separately so one patient with bilateral knee osteoarthritis will be counted as 2 knees.
boolean
C0022417 (UMLS CUI [1,1])
C0443299 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
C1265611 (UMLS CUI [1,5])
Osteoarthritis clinical score | Kellgren and Lawrence grading
Item
the osteoarthritis will be graded on basis of clinical score as well as seen on appropriately positioned x rays using the kellgren and lawrence grading. (tibio femoral osteophytes of at least 1 mm, kellgren lawrence grading of 2 or 3)
boolean
C0409959 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C3177117 (UMLS CUI [2])
Hba1c levels normal in diabetic patients
Item
patients with diabetes are sent to the diabetes clinic and are included once their hba1c level becomes normal.
boolean
C0474680 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0241863 (UMLS CUI [1,4])
Informed consent
Item
patients giving informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Severe end stage tricompartmental osteoarthritis of the knees
Item
patients with severe end stage tricompartmental osteoarthritis of the knees .
boolean
C0409959 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205088 (UMLS CUI [1,3])
C0447798 (UMLS CUI [1,4])
C1265611 (UMLS CUI [1,5])
Uncontrolled systemic disease
Item
presence of uncontrolled systemic disease like chronic liver and renal disease
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Diagnosis other than osteoarthritis
Item
patients with diagnosis other than osteoarthritis, such as knee arthritis due to rheumatoid disease, gout, post traumatic arthritis
boolean
C0205394 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0409959 (UMLS CUI [1,4])
History of knee surgery in the site of lesion
Item
patients with history of surgery to any knee will have that knee excluded
boolean
C0543467 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,4])
Pregnancy | Breast feeding
Item
pregnant or lactating mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chronic anaemia
Item
patients with chronic anaemia
boolean
C0002871 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Injection in affected knee
Item
patients who get an injection in their affected knee
boolean
C1828121 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
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