ID

31312

Description

BION Treatment of Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00689286

Link

https://clinicaltrials.gov/show/NCT00689286

Keywords

Versions (1)
  1. 8/12/18 8/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee NCT00689286

English

Eligibility Osteoarthritis, Knee NCT00689286

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject presents with osteoarthritis of the knee with severity defined as kellgren-lawrence grade 3-4.
Description

Knee Osteoarthritis Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3177117
2. subject is between 18 and 75 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. attending physician considers the subject in general good health (other than knee joint osteoarthritis).
Description

General health good | Exception Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0029408
4. subject is mentally capable of understanding the goals and the application of therapy.
Description

Comprehension Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
5. subject is able to apply the therapy (with or without help) in the home setting.
Description

Ability Self-treatment Home environment

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0679887
UMLS CUI [1,3]
C0442519
6. subject is willing and capable of giving informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
7. subject is willing and capable of traveling to testing center at the schedule described above and detailed in table 2.
Description

Traveling Testing Center

Data type

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C1552531
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject is pregnant, nursing, or planning to become pregnant in the next 12 months.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
2. subject has an electronic implant (e.g. cardiac pacemaker, etc.).
Description

Implant Electronic | Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0013850
UMLS CUI [2]
C0030163
3. subject has metallic implant (e.g. plates, hip joints) in the buttock or upper leg.
Description

Metallic implant Buttocks | Metallic implant Thigh | Plates | Hip Joint Implantable Prostheses

Data type

boolean

Alias
UMLS CUI [1,1]
C3693688
UMLS CUI [1,2]
C0006497
UMLS CUI [2,1]
C3693688
UMLS CUI [2,2]
C0039866
UMLS CUI [3]
C1139930
UMLS CUI [4]
C0019560
4. subject has a history of falling.
Description

Falling

Data type

boolean

Alias
UMLS CUI [1]
C0000921
5. subject has medical conditions other than oa affecting the legs that could affect treatment or mobility.
Description

Medical condition Affecting Legs | Medical condition Affecting Therapeutic procedure | Medical condition Affecting Musculoskeletal mobility | Exception Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1140621
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0231434
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0029408
6. subject is 40% or more above the ideal weight recommended by metropolitan life.
Description

Body Weight Greater Than Ideal Body Weight

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439093
UMLS CUI [1,3]
C0421272
7. subject has cancer.
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
8. subject is currently enrolled in another clinical trial or research study that involves therapy or intervention which would affect lower extremity mobility.
Description

Study Subject Participation Status | Therapeutic procedure Affecting Mobility Lower Extremity | Intervention Affecting Mobility Lower Extremity

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0231434
UMLS CUI [2,4]
C0023216
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0231434
UMLS CUI [3,4]
C0023216
9. subject has bilateral knee osteoarthritis.
Description

Bilateral primary osteoarthritis of knee

Data type

boolean

Alias
UMLS CUI [1]
C2893930
10. subject is taking pain medications with dosage not stable for one month.
Description

Analgesics Dosage Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443343
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Similar models

Eligibility Osteoarthritis, Knee NCT00689286

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Knee Osteoarthritis Kellgren-Lawrence score
Item
1. subject presents with osteoarthritis of the knee with severity defined as kellgren-lawrence grade 3-4.
boolean
C0409959 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
Age
Item
2. subject is between 18 and 75 years old.
boolean
C0001779 (UMLS CUI [1])
General health good | Exception Osteoarthritis
Item
3. attending physician considers the subject in general good health (other than knee joint osteoarthritis).
boolean
C1277245 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
Comprehension Study Protocol
Item
4. subject is mentally capable of understanding the goals and the application of therapy.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Ability Self-treatment Home environment
Item
5. subject is able to apply the therapy (with or without help) in the home setting.
boolean
C0085732 (UMLS CUI [1,1])
C0679887 (UMLS CUI [1,2])
C0442519 (UMLS CUI [1,3])
Informed Consent
Item
6. subject is willing and capable of giving informed consent.
boolean
C0021430 (UMLS CUI [1])
Traveling Testing Center
Item
7. subject is willing and capable of traveling to testing center at the schedule described above and detailed in table 2.
boolean
C0040802 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C1552531 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
1. subject is pregnant, nursing, or planning to become pregnant in the next 12 months.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Implant Electronic | Artificial cardiac pacemaker
Item
2. subject has an electronic implant (e.g. cardiac pacemaker, etc.).
boolean
C0021102 (UMLS CUI [1,1])
C0013850 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
Metallic implant Buttocks | Metallic implant Thigh | Plates | Hip Joint Implantable Prostheses
Item
3. subject has metallic implant (e.g. plates, hip joints) in the buttock or upper leg.
boolean
C3693688 (UMLS CUI [1,1])
C0006497 (UMLS CUI [1,2])
C3693688 (UMLS CUI [2,1])
C0039866 (UMLS CUI [2,2])
C1139930 (UMLS CUI [3])
C0019560 (UMLS CUI [4])
Falling
Item
4. subject has a history of falling.
boolean
C0000921 (UMLS CUI [1])
Medical condition Affecting Legs | Medical condition Affecting Therapeutic procedure | Medical condition Affecting Musculoskeletal mobility | Exception Osteoarthritis
Item
5. subject has medical conditions other than oa affecting the legs that could affect treatment or mobility.
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0231434 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0029408 (UMLS CUI [4,2])
Body Weight Greater Than Ideal Body Weight
Item
6. subject is 40% or more above the ideal weight recommended by metropolitan life.
boolean
C0005910 (UMLS CUI [1,1])
C0439093 (UMLS CUI [1,2])
C0421272 (UMLS CUI [1,3])
Malignant Neoplasms
Item
7. subject has cancer.
boolean
C0006826 (UMLS CUI [1])
Study Subject Participation Status | Therapeutic procedure Affecting Mobility Lower Extremity | Intervention Affecting Mobility Lower Extremity
Item
8. subject is currently enrolled in another clinical trial or research study that involves therapy or intervention which would affect lower extremity mobility.
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0231434 (UMLS CUI [2,3])
C0023216 (UMLS CUI [2,4])
C0184661 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0231434 (UMLS CUI [3,3])
C0023216 (UMLS CUI [3,4])
Bilateral primary osteoarthritis of knee
Item
9. subject has bilateral knee osteoarthritis.
boolean
C2893930 (UMLS CUI [1])
Analgesics Dosage Unstable
Item
10. subject is taking pain medications with dosage not stable for one month.
boolean
C0002771 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
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