ID

44284

Description

The Effects of Specialized Footwear in Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01597830

Link

https://clinicaltrials.gov/show/NCT01597830

Keywords

Versions (3)
  1. 5/15/18 5/15/18 -
  2. 5/15/18 5/15/18 -
  3. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Knee Osteoarthritis NCT01597830

English

Eligibility Knee Osteoarthritis NCT01597830

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 oa of the knee, as defined by the american college of rheumatology's clinical criteria for classification and reporting of oa of the knee. if symptoms are bilateral, then the knee identified by the subject as more symptomatic will serve as the index knee.
Description

Knee Osteoarthritis Symptomatic | Symptoms Bilateral | Knee More Symptomatic Involved

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0238767
UMLS CUI [3,1]
C0022742
UMLS CUI [3,2]
C0205172
UMLS CUI [3,3]
C0231220
UMLS CUI [3,4]
C1314939
ambulatory knee pain, defined as the presence of greater than 30 mm of pain while walking on a flat surface (corresponding to question 1 of the visual analog format of the womac.
Description

Pain of knee observed on ambulation WOMAC scale | Pain walking on the flat

Data type

boolean

Alias
UMLS CUI [1,1]
C2090050
UMLS CUI [1,2]
C3472647
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0560053
radiographic oa of the study knee of grade 2 or 3, as defined by the modified kellgren and lawrence (k-l) grading scale.
Description

Knee Osteoarthritis Radiography Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0034571
UMLS CUI [1,3]
C3177117
medial compartment oa, defined as either qualitative joint space narrowing of ≥ 1or the presence of medial bone cyst, sclerosis, or osteophyte.
Description

Osteoarthritis Medial compartment of knee | Narrowed joint space Qualitative | Bone Cyst Medial | Sclerosis | Osteophyte

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0447799
UMLS CUI [2,1]
C1859695
UMLS CUI [2,2]
C0205556
UMLS CUI [3,1]
C0005937
UMLS CUI [3,2]
C0205098
UMLS CUI [4]
C0036429
UMLS CUI [5]
C1956089
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability or unwillingness to wear study shoes for at least 6 hours/day for 6 days/week
Description

Wear appropriate shoes Clinical Trial Unable | Wear appropriate shoes Clinical Trial Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C2203003
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C2203003
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0558080
knee flexion contracture of > 15 degrees or inability to ambulate without assistance.
Description

Flexion contracture of the knee Degree Quantity | Difficulty walking unassisted

Data type

boolean

Alias
UMLS CUI [1,1]
C0409355
UMLS CUI [1,2]
C2348088
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C2183457
presence of clinically significant oa of the hip or ankle or pain greater than 20 mm at these sites (womac).
Description

Osteoarthritis of hip | Osteoarthritis of ankle | Pain Hip WOMAC scale | Pain Ankle WOMAC scale

Data type

boolean

Alias
UMLS CUI [1]
C0029410
UMLS CUI [2]
C0409931
UMLS CUI [3,1]
C0030193
UMLS CUI [3,2]
C0019552
UMLS CUI [3,3]
C3472647
UMLS CUI [4,1]
C0030193
UMLS CUI [4,2]
C0003086
UMLS CUI [4,3]
C3472647
> 3 degrees valgus or >12 degrees varus deformity of either knee, defined by the mechanical axis (hip-knee angle).
Description

Valgus deformity Knee Degree Quantity | Varus angulation Knee Degree Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0042282
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C2348088
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0432593
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C2348088
UMLS CUI [2,4]
C1265611
predominant lateral compartment oa, defined as narrowing of the lateral joint space in excess of the narrowing of the medial joint space in either the index or the contralateral knee.
Description

Osteoarthritis Lateral compartment of knee Predominant | Narrowed joint space Lateral Knee Involved | Narrowed joint space Medial Knee Involved | Narrowed joint space Lateral Knee Contralateral | Narrowed joint space Medial Knee Contralateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0447800
UMLS CUI [1,3]
C1542147
UMLS CUI [2,1]
C1859695
UMLS CUI [2,2]
C0205093
UMLS CUI [2,3]
C0022742
UMLS CUI [2,4]
C1314939
UMLS CUI [3,1]
C1859695
UMLS CUI [3,2]
C0205098
UMLS CUI [3,3]
C0022742
UMLS CUI [3,4]
C1314939
UMLS CUI [4,1]
C1859695
UMLS CUI [4,2]
C0205093
UMLS CUI [4,3]
C0022742
UMLS CUI [4,4]
C0441988
UMLS CUI [5,1]
C1859695
UMLS CUI [5,2]
C0205098
UMLS CUI [5,3]
C0022742
UMLS CUI [5,4]
C0441988
concurrent systemic inflammatory arthropathy,
Description

Arthritis Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205373
prior knee or hip arthroplasty, or surgical arthroscopy of either knee within previous 3 months or history of fracture of either lower extremity within 6 months of study entry.
Description

Knee Arthroplasty | Repair of hip | Arthroscopy, knee, surgical | Fracture of lower limb

Data type

boolean

Alias
UMLS CUI [1]
C0086511
UMLS CUI [2]
C0186193
UMLS CUI [3]
C3701616
UMLS CUI [4]
C0810370
intrinsic foot disease including hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated by particular footwear.
Description

Foot Disease Intrinsic | Hallux Rigidus | Hallux Valgus | Metatarsalgia | Fasciitis, Plantar | Peripheral Neuropathy | Condition affecting the foot Exacerbated Footwear

Data type

boolean

Alias
UMLS CUI [1,1]
C0016510
UMLS CUI [1,2]
C0205102
UMLS CUI [2]
C0264134
UMLS CUI [3]
C0018536
UMLS CUI [4]
C0025587
UMLS CUI [5]
C0149756
UMLS CUI [6]
C0031117
UMLS CUI [7,1]
C4061112
UMLS CUI [7,2]
C1444749
UMLS CUI [7,3]
C0336894
intra-articular injection in the index knee: steroids within 6 weeks, hyaluronan derivatives within 4 months.
Description

Intra-Articular Injection Knee Involved | Steroids | Hyaluronan Derivative

Data type

boolean

Alias
UMLS CUI [1,1]
C0021488
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C1314939
UMLS CUI [2]
C0038317
UMLS CUI [3,1]
C0020196
UMLS CUI [3,2]
C1527240
pregnant subjects will be excluded because of the x-rays required.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
any medical condition that, in the opinion of the pi, would render the subject unable to complete the study.
Description

Medical condition Completion of clinical trial Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2732579
UMLS CUI [1,3]
C1299582
Back to the top of the page

Similar models

Eligibility Knee Osteoarthritis NCT01597830

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 | Symptoms Bilateral | Knee More Symptomatic Involved
Item
symptomatic oa of the knee, as defined by the american college of rheumatology's clinical criteria for classification and reporting of oa of the knee. if symptoms are bilateral, then the knee identified by the subject as more symptomatic will serve as the index knee.
boolean
C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0238767 (UMLS CUI [2,2])
C0022742 (UMLS CUI [3,1])
C0205172 (UMLS CUI [3,2])
C0231220 (UMLS CUI [3,3])
C1314939 (UMLS CUI [3,4])
Pain of knee observed on ambulation WOMAC scale | Pain walking on the flat
Item
ambulatory knee pain, defined as the presence of greater than 30 mm of pain while walking on a flat surface (corresponding to question 1 of the visual analog format of the womac.
boolean
C2090050 (UMLS CUI [1,1])
C3472647 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C0560053 (UMLS CUI [2,2])
Knee Osteoarthritis Radiography Kellgren-Lawrence score
Item
radiographic oa of the study knee of grade 2 or 3, as defined by the modified kellgren and lawrence (k-l) grading scale.
boolean
C0409959 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C3177117 (UMLS CUI [1,3])
Osteoarthritis Medial compartment of knee | Narrowed joint space Qualitative | Bone Cyst Medial | Sclerosis | Osteophyte
Item
medial compartment oa, defined as either qualitative joint space narrowing of ≥ 1or the presence of medial bone cyst, sclerosis, or osteophyte.
boolean
C0029408 (UMLS CUI [1,1])
C0447799 (UMLS CUI [1,2])
C1859695 (UMLS CUI [2,1])
C0205556 (UMLS CUI [2,2])
C0005937 (UMLS CUI [3,1])
C0205098 (UMLS CUI [3,2])
C0036429 (UMLS CUI [4])
C1956089 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Wear appropriate shoes Clinical Trial Unable | Wear appropriate shoes Clinical Trial Unwilling
Item
inability or unwillingness to wear study shoes for at least 6 hours/day for 6 days/week
boolean
C2203003 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C2203003 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Flexion contracture of the knee Degree Quantity | Difficulty walking unassisted
Item
knee flexion contracture of > 15 degrees or inability to ambulate without assistance.
boolean
C0409355 (UMLS CUI [1,1])
C2348088 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2183457 (UMLS CUI [2])
Osteoarthritis of hip | Osteoarthritis of ankle | Pain Hip WOMAC scale | Pain Ankle WOMAC scale
Item
presence of clinically significant oa of the hip or ankle or pain greater than 20 mm at these sites (womac).
boolean
C0029410 (UMLS CUI [1])
C0409931 (UMLS CUI [2])
C0030193 (UMLS CUI [3,1])
C0019552 (UMLS CUI [3,2])
C3472647 (UMLS CUI [3,3])
C0030193 (UMLS CUI [4,1])
C0003086 (UMLS CUI [4,2])
C3472647 (UMLS CUI [4,3])
Valgus deformity Knee Degree Quantity | Varus angulation Knee Degree Quantity
Item
> 3 degrees valgus or >12 degrees varus deformity of either knee, defined by the mechanical axis (hip-knee angle).
boolean
C0042282 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C2348088 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0432593 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C2348088 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Osteoarthritis Lateral compartment of knee Predominant | Narrowed joint space Lateral Knee Involved | Narrowed joint space Medial Knee Involved | Narrowed joint space Lateral Knee Contralateral | Narrowed joint space Medial Knee Contralateral
Item
predominant lateral compartment oa, defined as narrowing of the lateral joint space in excess of the narrowing of the medial joint space in either the index or the contralateral knee.
boolean
C0029408 (UMLS CUI [1,1])
C0447800 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
C1859695 (UMLS CUI [2,1])
C0205093 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
C1314939 (UMLS CUI [2,4])
C1859695 (UMLS CUI [3,1])
C0205098 (UMLS CUI [3,2])
C0022742 (UMLS CUI [3,3])
C1314939 (UMLS CUI [3,4])
C1859695 (UMLS CUI [4,1])
C0205093 (UMLS CUI [4,2])
C0022742 (UMLS CUI [4,3])
C0441988 (UMLS CUI [4,4])
C1859695 (UMLS CUI [5,1])
C0205098 (UMLS CUI [5,2])
C0022742 (UMLS CUI [5,3])
C0441988 (UMLS CUI [5,4])
Arthritis Systemic
Item
concurrent systemic inflammatory arthropathy,
boolean
C0003864 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Knee Arthroplasty | Repair of hip | Arthroscopy, knee, surgical | Fracture of lower limb
Item
prior knee or hip arthroplasty, or surgical arthroscopy of either knee within previous 3 months or history of fracture of either lower extremity within 6 months of study entry.
boolean
C0086511 (UMLS CUI [1])
C0186193 (UMLS CUI [2])
C3701616 (UMLS CUI [3])
C0810370 (UMLS CUI [4])
Foot Disease Intrinsic | Hallux Rigidus | Hallux Valgus | Metatarsalgia | Fasciitis, Plantar | Peripheral Neuropathy | Condition affecting the foot Exacerbated Footwear
Item
intrinsic foot disease including hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated by particular footwear.
boolean
C0016510 (UMLS CUI [1,1])
C0205102 (UMLS CUI [1,2])
C0264134 (UMLS CUI [2])
C0018536 (UMLS CUI [3])
C0025587 (UMLS CUI [4])
C0149756 (UMLS CUI [5])
C0031117 (UMLS CUI [6])
C4061112 (UMLS CUI [7,1])
C1444749 (UMLS CUI [7,2])
C0336894 (UMLS CUI [7,3])
Intra-Articular Injection Knee Involved | Steroids | Hyaluronan Derivative
Item
intra-articular injection in the index knee: steroids within 6 weeks, hyaluronan derivatives within 4 months.
boolean
C0021488 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2])
C0020196 (UMLS CUI [3,1])
C1527240 (UMLS CUI [3,2])
Pregnancy
Item
pregnant subjects will be excluded because of the x-rays required.
boolean
C0032961 (UMLS CUI [1])
Medical condition Completion of clinical trial Unable
Item
any medical condition that, in the opinion of the pi, would render the subject unable to complete the study.
boolean
C3843040 (UMLS CUI [1,1])
C2732579 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial