ID

18603

Description

A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00076453

Link

https://clinicaltrials.gov/show/NCT00076453

Keywords

Versions (1)
  1. 11/12/16 11/12/16 -
Uploaded on

November 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00076453

English

Eligibility Osteoarthritis NCT00076453

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
able and willing to give informed consent and to comply with the study protocol and follow-up instructions
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
symptomatic and radiographic oa of the knee
Description

Knee Osteoarthritis Symptomatic | Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0034571
knee pain upon walking
Description

Knee pain During Walking

Data type

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0080331
predominant medial compartment oa
Description

Osteoarthritis Medial compartment of knee predominant

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0447799
UMLS CUI [1,3]
C1542147
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
knee flexion contracture of greater than 15 degrees or inability to walk without assistance
Description

Flexion contracture of the knee Degree | Unable to walk

Data type

boolean

Alias
UMLS CUI [1,1]
C0409355
UMLS CUI [1,2]
C0449286
UMLS CUI [2]
C0560046
predominant lateral compartment oa of either knee
Description

Osteoarthritis Lateral compartment of knee predominant

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0447800
UMLS CUI [1,3]
C1542147
greater than 3 degree valgus or greater than 12 degree varus deformity of either knee, as defined by the mechanical axis
Description

Valgus deformity Knee Degree | Varus angulation Knee Degree

Data type

boolean

Alias
UMLS CUI [1,1]
C0042282
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0449286
UMLS CUI [2,1]
C0432593
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C0449286
clinically evident oa of the ankle or hip
Description

Osteoarthritis of ankle Evidence of | Osteoarthritis of hip Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0409931
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0029410
UMLS CUI [2,2]
C0332120
clinically significant intrinsic foot disease upon podiatric evaluation, including any foot condition that may be aggravated by wearing orthotics
Description

Foot Disease Intrinsic | Foot Condition Exacerbated Due to Orthotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0016510
UMLS CUI [1,2]
C0439674
UMLS CUI [2,1]
C0016504
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C1444749
UMLS CUI [2,4]
C0678226
UMLS CUI [2,5]
C3687840
substantial obesity, defined as having body mass index (bmi) greater than 35
Description

Obesity | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0028754
UMLS CUI [2]
C1305855
anticipation of surgery involving any joint of either lower extremity in the next 3 years
Description

Operative Surgical Procedures anticipation Involving Joint of lower extremity

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0679106
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0584731
habitual use of inappropriate shoewear that would interfere with adequate use of the orthotic inserts
Description

uneven shoe wear Interferes with Orthotic Shoe Inserts

Data type

boolean

Alias
UMLS CUI [1,1]
C2128942
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C3494214
inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout
Description

Arthritis | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Gout

Data type

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0018099
chronic infection in any joint of the lower extremities
Description

Chronic infectious disease Joint of lower extremity

Data type

boolean

Alias
UMLS CUI [1,1]
C0151317
UMLS CUI [1,2]
C0584731
history of fracture of either lower extremity within 6 months of study entry
Description

Fracture of lower leg

Data type

boolean

Alias
UMLS CUI [1]
C1542178
history of knee or hip arthroplasty or of surgical arthroscopy of either knee within 3 months of study entry
Description

Knee Replacement Arthroplasty | Repair of hip | Arthroscopy, knee, surgical

Data type

boolean

Alias
UMLS CUI [1]
C0086511
UMLS CUI [2]
C0186193
UMLS CUI [3]
C3701616
history of intra-articular injections (glucocorticoids or hyaluronic acid derivatives) in the index knee within 6 months of study entry
Description

Intra-Articular Injections Knee Involved | Glucocorticoids | Hyaluronic Acid derivatives

Data type

boolean

Alias
UMLS CUI [1,1]
C0021488
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C1314939
UMLS CUI [2]
C0017710
UMLS CUI [3,1]
C0020196
UMLS CUI [3,2]
C0243072
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
any medical condition which, in the opinion of the investigator, would render the patient unable to comply with the protocol
Description

Medical condition Preventing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
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Similar models

Eligibility Osteoarthritis NCT00076453

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Protocol Compliance
Item
able and willing to give informed consent and to comply with the study protocol and follow-up instructions
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Knee Osteoarthritis Symptomatic | Radiography
Item
symptomatic and radiographic oa of the knee
boolean
C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0034571 (UMLS CUI [2])
Knee pain During Walking
Item
knee pain upon walking
boolean
C0231749 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
Osteoarthritis Medial compartment of knee predominant
Item
predominant medial compartment oa
boolean
C0029408 (UMLS CUI [1,1])
C0447799 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Flexion contracture of the knee Degree | Unable to walk
Item
knee flexion contracture of greater than 15 degrees or inability to walk without assistance
boolean
C0409355 (UMLS CUI [1,1])
C0449286 (UMLS CUI [1,2])
C0560046 (UMLS CUI [2])
Osteoarthritis Lateral compartment of knee predominant
Item
predominant lateral compartment oa of either knee
boolean
C0029408 (UMLS CUI [1,1])
C0447800 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Valgus deformity Knee Degree | Varus angulation Knee Degree
Item
greater than 3 degree valgus or greater than 12 degree varus deformity of either knee, as defined by the mechanical axis
boolean
C0042282 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0449286 (UMLS CUI [1,3])
C0432593 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0449286 (UMLS CUI [2,3])
Osteoarthritis of ankle Evidence of | Osteoarthritis of hip Evidence of
Item
clinically evident oa of the ankle or hip
boolean
C0409931 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0029410 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Foot Disease Intrinsic | Foot Condition Exacerbated Due to Orthotics
Item
clinically significant intrinsic foot disease upon podiatric evaluation, including any foot condition that may be aggravated by wearing orthotics
boolean
C0016510 (UMLS CUI [1,1])
C0439674 (UMLS CUI [1,2])
C0016504 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C1444749 (UMLS CUI [2,3])
C0678226 (UMLS CUI [2,4])
C3687840 (UMLS CUI [2,5])
Obesity | Body mass index
Item
substantial obesity, defined as having body mass index (bmi) greater than 35
boolean
C0028754 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Operative Surgical Procedures anticipation Involving Joint of lower extremity
Item
anticipation of surgery involving any joint of either lower extremity in the next 3 years
boolean
C0543467 (UMLS CUI [1,1])
C0679106 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0584731 (UMLS CUI [1,4])
uneven shoe wear Interferes with Orthotic Shoe Inserts
Item
habitual use of inappropriate shoewear that would interfere with adequate use of the orthotic inserts
boolean
C2128942 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3494214 (UMLS CUI [1,3])
Arthritis | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Gout
Item
inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout
boolean
C0003864 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
C0018099 (UMLS CUI [4])
Chronic infectious disease Joint of lower extremity
Item
chronic infection in any joint of the lower extremities
boolean
C0151317 (UMLS CUI [1,1])
C0584731 (UMLS CUI [1,2])
Fracture of lower leg
Item
history of fracture of either lower extremity within 6 months of study entry
boolean
C1542178 (UMLS CUI [1])
Knee Replacement Arthroplasty | Repair of hip | Arthroscopy, knee, surgical
Item
history of knee or hip arthroplasty or of surgical arthroscopy of either knee within 3 months of study entry
boolean
C0086511 (UMLS CUI [1])
C0186193 (UMLS CUI [2])
C3701616 (UMLS CUI [3])
Intra-Articular Injections Knee Involved | Glucocorticoids | Hyaluronic Acid derivatives
Item
history of intra-articular injections (glucocorticoids or hyaluronic acid derivatives) in the index knee within 6 months of study entry
boolean
C0021488 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0017710 (UMLS CUI [2])
C0020196 (UMLS CUI [3,1])
C0243072 (UMLS CUI [3,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Medical condition Preventing Protocol Compliance
Item
any medical condition which, in the opinion of the investigator, would render the patient unable to comply with the protocol
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
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