ID

18674

Description

Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb (BTOA); ODM derived from: https://clinicaltrials.gov/show/NCT00350896

Link

https://clinicaltrials.gov/show/NCT00350896

Keywords

Versions (1)
  1. 11/15/16 11/15/16 -
Uploaded on

November 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00350896

English

Eligibility Osteoarthritis NCT00350896

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pain at the base of the thumb 30 mm on vas
Description

Pain Base of phalanx of thumb | Visual analog scale score

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0223813
UMLS CUI [2]
C2960751
patient aged 45 and < 75 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
at least 2 of the 5 items on the trapeziometacarpal joint radiograph osteophytes
Description

Carpometacarpal joint structure of thumb Osteophyte Quantity | radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0224622
UMLS CUI [1,2]
C1956089
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0034571
joint space narrowing
Description

Narrowed joint space

Data type

boolean

Alias
UMLS CUI [1]
C1859695
subchondral bone sclerosis
Description

Sclerosis of subchondral bone of joint

Data type

boolean

Alias
UMLS CUI [1]
C3670825
subchondral cysts
Description

Subchondral Cysts

Data type

boolean

Alias
UMLS CUI [1]
C0038529
at least 1 of the 2 clinical items trapeziometacarpal joint enlargement closure of the first web
Description

Carpometacarpal joint structure of thumb Enlargement | First web space Closed

Data type

boolean

Alias
UMLS CUI [1,1]
C0224622
UMLS CUI [1,2]
C2711450
UMLS CUI [2,1]
C2945635
UMLS CUI [2,2]
C0587267
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
post traumatic osteoarthritis
Description

Osteoarthritis Posttraumatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0231288
cristal arthropathy
Description

Crystal arthropathy

Data type

boolean

Alias
UMLS CUI [1]
C0152087
inflammatory arthritis
Description

Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003864
neurologic disorder involving upper limb
Description

nervous system disorder Involving Upper limb

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1140618
psychiatric disorder needing treatment adaptation in the last 3 months
Description

Mental disorder Requirement Therapeutic procedure Adjustment

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0456081
hand or wrist trauma within the last 2 months
Description

HAND INJURY TRAUMA | WRIST INJURY TRAUMA

Data type

boolean

Alias
UMLS CUI [1]
C0744558
UMLS CUI [2]
C0750453
previous hand surgery
Description

Operative procedure on hand

Data type

boolean

Alias
UMLS CUI [1]
C0187067
unable to speak or write french
Description

Able to speak French language | Able to write French language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376246
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376246
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
collagen diseases (dupuytren, marfan, ehlers danlos syndromes)
Description

Collagen Diseases | Dupuytren Contracture | Marfan Syndrome | Ehlers-Danlos Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0009326
UMLS CUI [2]
C0013312
UMLS CUI [3]
C0024796
UMLS CUI [4]
C0013720
hand or wrist infiltration within 2 months
Description

Hand Infiltration | Wrist Infiltration

Data type

boolean

Alias
UMLS CUI [1,1]
C0018563
UMLS CUI [1,2]
C0702249
UMLS CUI [2,1]
C0043262
UMLS CUI [2,2]
C0702249
skin disease interfering with the wearing of the orthoses
Description

Dermatologic disorder Interferes with Use of Orthoses

Data type

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C0029365
having already worn a btoa orthoses
Description

Thumb osteoarthritis Orthosis user

Data type

boolean

Alias
UMLS CUI [1,1]
C0409935
UMLS CUI [1,2]
C1739370
having bilateral btoa without predominant symptomatic side
Description

Thumb osteoarthritis Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0409935
UMLS CUI [1,2]
C0238767
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Similar models

Eligibility Osteoarthritis NCT00350896

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Pain Base of phalanx of thumb | Visual analog scale score
Item
pain at the base of the thumb 30 mm on vas
boolean
C0030193 (UMLS CUI [1,1])
C0223813 (UMLS CUI [1,2])
C2960751 (UMLS CUI [2])
Age
Item
patient aged 45 and < 75 years old
boolean
C0001779 (UMLS CUI [1])
Carpometacarpal joint structure of thumb Osteophyte Quantity | radiography
Item
at least 2 of the 5 items on the trapeziometacarpal joint radiograph osteophytes
boolean
C0224622 (UMLS CUI [1,1])
C1956089 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0034571 (UMLS CUI [2])
Narrowed joint space
Item
joint space narrowing
boolean
C1859695 (UMLS CUI [1])
Sclerosis of subchondral bone of joint
Item
subchondral bone sclerosis
boolean
C3670825 (UMLS CUI [1])
Subchondral Cysts
Item
subchondral cysts
boolean
C0038529 (UMLS CUI [1])
Carpometacarpal joint structure of thumb Enlargement | First web space Closed
Item
at least 1 of the 2 clinical items trapeziometacarpal joint enlargement closure of the first web
boolean
C0224622 (UMLS CUI [1,1])
C2711450 (UMLS CUI [1,2])
C2945635 (UMLS CUI [2,1])
C0587267 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Osteoarthritis Posttraumatic
Item
post traumatic osteoarthritis
boolean
C0029408 (UMLS CUI [1,1])
C0231288 (UMLS CUI [1,2])
Crystal arthropathy
Item
cristal arthropathy
boolean
C0152087 (UMLS CUI [1])
Arthritis
Item
inflammatory arthritis
boolean
C0003864 (UMLS CUI [1])
nervous system disorder Involving Upper limb
Item
neurologic disorder involving upper limb
boolean
C0027765 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1140618 (UMLS CUI [1,3])
Mental disorder Requirement Therapeutic procedure Adjustment
Item
psychiatric disorder needing treatment adaptation in the last 3 months
boolean
C0004936 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0456081 (UMLS CUI [1,4])
HAND INJURY TRAUMA | WRIST INJURY TRAUMA
Item
hand or wrist trauma within the last 2 months
boolean
C0744558 (UMLS CUI [1])
C0750453 (UMLS CUI [2])
Operative procedure on hand
Item
previous hand surgery
boolean
C0187067 (UMLS CUI [1])
Able to speak French language | Able to write French language
Item
unable to speak or write french
boolean
C0564215 (UMLS CUI [1,1])
C0376246 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376246 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Collagen Diseases | Dupuytren Contracture | Marfan Syndrome | Ehlers-Danlos Syndrome
Item
collagen diseases (dupuytren, marfan, ehlers danlos syndromes)
boolean
C0009326 (UMLS CUI [1])
C0013312 (UMLS CUI [2])
C0024796 (UMLS CUI [3])
C0013720 (UMLS CUI [4])
Hand Infiltration | Wrist Infiltration
Item
hand or wrist infiltration within 2 months
boolean
C0018563 (UMLS CUI [1,1])
C0702249 (UMLS CUI [1,2])
C0043262 (UMLS CUI [2,1])
C0702249 (UMLS CUI [2,2])
Dermatologic disorder Interferes with Use of Orthoses
Item
skin disease interfering with the wearing of the orthoses
boolean
C0037274 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0029365 (UMLS CUI [1,4])
Thumb osteoarthritis Orthosis user
Item
having already worn a btoa orthoses
boolean
C0409935 (UMLS CUI [1,1])
C1739370 (UMLS CUI [1,2])
Thumb osteoarthritis Bilateral
Item
having bilateral btoa without predominant symptomatic side
boolean
C0409935 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
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