ID

18674

Beschrijving

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

Trefwoorden

  1. 15-11-16 15-11-16 -
Geüploaded op

15 november 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Osteoarthritis NCT00350896

Eligibility Osteoarthritis NCT00350896

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Pain Base of phalanx of thumb | Visual analog scale score

Datatype

boolean

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

Age

Datatype

boolean

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

Carpometacarpal joint structure of thumb Osteophyte Quantity | radiography

Datatype

boolean

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

Narrowed joint space

Datatype

boolean

Alias
UMLS CUI [1]
C1859695
subchondral bone sclerosis
Beschrijving

Sclerosis of subchondral bone of joint

Datatype

boolean

Alias
UMLS CUI [1]
C3670825
subchondral cysts
Beschrijving

Subchondral Cysts

Datatype

boolean

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

Carpometacarpal joint structure of thumb Enlargement | First web space Closed

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
post traumatic osteoarthritis
Beschrijving

Osteoarthritis Posttraumatic

Datatype

boolean

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

Crystal arthropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0152087
inflammatory arthritis
Beschrijving

Arthritis

Datatype

boolean

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

nervous system disorder Involving Upper limb

Datatype

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
Beschrijving

Mental disorder Requirement Therapeutic procedure Adjustment

Datatype

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
Beschrijving

HAND INJURY TRAUMA | WRIST INJURY TRAUMA

Datatype

boolean

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

Operative procedure on hand

Datatype

boolean

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

Able to speak French language | Able to write French language

Datatype

boolean

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

Pregnancy

Datatype

boolean

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

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

Datatype

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
Beschrijving

Hand Infiltration | Wrist Infiltration

Datatype

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
Beschrijving

Dermatologic disorder Interferes with Use of Orthoses

Datatype

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
Beschrijving

Thumb osteoarthritis Orthosis user

Datatype

boolean

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

Thumb osteoarthritis Bilateral

Datatype

boolean

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

Similar models

Eligibility Osteoarthritis NCT00350896

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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