ID

36229

Description

A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone; ODM derived from: https://clinicaltrials.gov/show/NCT02003976

Link

https://clinicaltrials.gov/show/NCT02003976

Keywords

Versions (1)
  1. 4/23/19 4/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02003976

English

Eligibility Knee Osteoarthritis NCT02003976

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. is the subject either:
Description

Study Subject

Data type

boolean

Alias
UMLS CUI [1]
C0681850
1. 25-55 years old?
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. older than 55 but still active (ex. physical labour, regular recreational activities)?
Description

Age | Physical activity | Recreational activity Regular

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0026606
UMLS CUI [3,1]
C0034872
UMLS CUI [3,2]
C0205272
2. does this subject present with varus alignment? (based on hip to ankle x-rays).
Description

Genu varum Alignment | Radiography of hip | Radiography of ankle

Data type

boolean

Alias
UMLS CUI [1,1]
C0544755
UMLS CUI [1,2]
C1706765
UMLS CUI [2]
C0203262
UMLS CUI [3]
C0203281
3. does this subject have clinical knee oa? (maa <-2° on full limb standing ap) according to the altman classification primarily involving the medial compartment of the knee?
Description

Osteoarthritis, Knee | Involvement with Medial compartment of knee

Data type

boolean

Alias
UMLS CUI [1]
C0409959
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0447799
4. patient is a good candidate for high tibial osteotomy and will be receiving a peek plate, or if receiving an alternate plate, agrees to have the plate removed prior to 1 year postoperative.
Description

Patients Appropriate High tibial osteotomy | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0407484
UMLS CUI [2]
C3846158
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. has this subject had a previous hto or joint replacement in either limb?
Description

High tibial osteotomy Previous | Joint replacement Limb

Data type

boolean

Alias
UMLS CUI [1,1]
C0407484
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1442800
UMLS CUI [2,2]
C0015385
2. is this subject likely to undergo bilateral hto within the 2 year follow up period?
Description

High tibial osteotomy Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0407484
UMLS CUI [1,2]
C0238767
3. does this subject have an unstable knee or ligament?
Description

Unstable knee | Ligament Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0427262
UMLS CUI [2,1]
C0023685
UMLS CUI [2,2]
C0443343
4. does this subject have inflammatory or infectious arthritis of the knee?
Description

Arthritis of knee inflammatory | Infectious arthritis of knee

Data type

boolean

Alias
UMLS CUI [1,1]
C0240111
UMLS CUI [1,2]
C0333348
UMLS CUI [2]
C2049885
5. radiographic disease too advanced for hto (ie. diffuse lateral compartment, patellofemoral joint oa and/or severe enough disease to suggest that joint replacement is the better surgical option) and/or kellgren and lawrence grade 4.
Description

Disease Inappropriate High tibial osteotomy | Lateral compartment of knee Diffuse | Patellofemoral osteoarthritis | Preference Joint replacement

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0407484
UMLS CUI [2,1]
C0447800
UMLS CUI [2,2]
C0205219
UMLS CUI [3]
C1542808
UMLS CUI [4,1]
C0558295
UMLS CUI [4,2]
C1442800
6. the subject's disease is not advanced enough (symptomatically or radiographically) to warrant hto.
Description

Disease Inappropriate High tibial osteotomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0407484
7. does this subject have a major medical illness with life expectancy <2 years or with an unacceptably high operative risk?
Description

Illness Major | Life Expectancy | Operative risk Unacceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0023671
UMLS CUI [3,1]
C0747003
UMLS CUI [3,2]
C1883420
8. does this subject have a major neurological deficit that would affect gait?
Description

Neurologic Deficit Affecting Gait

Data type

boolean

Alias
UMLS CUI [1,1]
C0521654
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0016928
9. is this subject possibly pregnant or planning pregnancy?
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
10. is this subject unable to read english?
Description

Lacking Able to read English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0376245
11. does this subject have a psychiatric illness that limits informed consent?
Description

Mental disorders Limiting Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0021430
12. is the subject unlikely to comply with study protocol?
Description

Protocol Compliance Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
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Similar models

Eligibility Knee Osteoarthritis NCT02003976

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject
Item
1. is the subject either:
boolean
C0681850 (UMLS CUI [1])
Age
Item
1. 25-55 years old?
boolean
C0001779 (UMLS CUI [1])
Age | Physical activity | Recreational activity Regular
Item
2. older than 55 but still active (ex. physical labour, regular recreational activities)?
boolean
C0001779 (UMLS CUI [1])
C0026606 (UMLS CUI [2])
C0034872 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
Genu varum Alignment | Radiography of hip | Radiography of ankle
Item
2. does this subject present with varus alignment? (based on hip to ankle x-rays).
boolean
C0544755 (UMLS CUI [1,1])
C1706765 (UMLS CUI [1,2])
C0203262 (UMLS CUI [2])
C0203281 (UMLS CUI [3])
Osteoarthritis, Knee | Involvement with Medial compartment of knee
Item
3. does this subject have clinical knee oa? (maa <-2° on full limb standing ap) according to the altman classification primarily involving the medial compartment of the knee?
boolean
C0409959 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0447799 (UMLS CUI [2,2])
Patients Appropriate High tibial osteotomy | Other Coding
Item
4. patient is a good candidate for high tibial osteotomy and will be receiving a peek plate, or if receiving an alternate plate, agrees to have the plate removed prior to 1 year postoperative.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0407484 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
High tibial osteotomy Previous | Joint replacement Limb
Item
1. has this subject had a previous hto or joint replacement in either limb?
boolean
C0407484 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1442800 (UMLS CUI [2,1])
C0015385 (UMLS CUI [2,2])
High tibial osteotomy Bilateral
Item
2. is this subject likely to undergo bilateral hto within the 2 year follow up period?
boolean
C0407484 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Unstable knee | Ligament Unstable
Item
3. does this subject have an unstable knee or ligament?
boolean
C0427262 (UMLS CUI [1])
C0023685 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Arthritis of knee inflammatory | Infectious arthritis of knee
Item
4. does this subject have inflammatory or infectious arthritis of the knee?
boolean
C0240111 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C2049885 (UMLS CUI [2])
Disease Inappropriate High tibial osteotomy | Lateral compartment of knee Diffuse | Patellofemoral osteoarthritis | Preference Joint replacement
Item
5. radiographic disease too advanced for hto (ie. diffuse lateral compartment, patellofemoral joint oa and/or severe enough disease to suggest that joint replacement is the better surgical option) and/or kellgren and lawrence grade 4.
boolean
C0012634 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0407484 (UMLS CUI [1,3])
C0447800 (UMLS CUI [2,1])
C0205219 (UMLS CUI [2,2])
C1542808 (UMLS CUI [3])
C0558295 (UMLS CUI [4,1])
C1442800 (UMLS CUI [4,2])
Disease Inappropriate High tibial osteotomy
Item
6. the subject's disease is not advanced enough (symptomatically or radiographically) to warrant hto.
boolean
C0012634 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0407484 (UMLS CUI [1,3])
Illness Major | Life Expectancy | Operative risk Unacceptable
Item
7. does this subject have a major medical illness with life expectancy <2 years or with an unacceptably high operative risk?
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2])
C0747003 (UMLS CUI [3,1])
C1883420 (UMLS CUI [3,2])
Neurologic Deficit Affecting Gait
Item
8. does this subject have a major neurological deficit that would affect gait?
boolean
C0521654 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0016928 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned
Item
9. is this subject possibly pregnant or planning pregnancy?
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Lacking Able to read English Language
Item
10. is this subject unable to read english?
boolean
C0332268 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Mental disorders Limiting Informed Consent
Item
11. does this subject have a psychiatric illness that limits informed consent?
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Protocol Compliance Unlikely
Item
12. is the subject unlikely to comply with study protocol?
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
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