Eligibility Osteoarthritis NCT00918736

1 Formulários

StudyEvent: Eligibility
1. Eligibility Osteoarthritis NCT00918736

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Item

were 18 years of age or older, reported unilateral ankle pain for at least 6 months and had either reported no significant benefit from conservative treatment (rest, physical therapy, orthoses or pain medications etc.) or were unable to tolerate side effects of medications

boolean

C0001779 (UMLS CUI [1])
C0238656 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0459914 (UMLS CUI [3,1])
C0814225 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C0035253 (UMLS CUI [4])
C0949766 (UMLS CUI [5])
C0029365 (UMLS CUI [6])
C0002771 (UMLS CUI [7])
C0041755 (UMLS CUI [8,1])
C0879626 (UMLS CUI [8,2])

Radiography of ankle Kellgren-Lawrence score

Item

ankle radiographs taken within 6 months were equivalent to grade 2 or 3 according to the kellgren-lawrence grading system (grade 2, definite osteophytes and possible narrowing of joint space; grade 3, moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour)22

boolean

C0203281 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])

Ankle Osteoarthritis Score

Item

had a current total aos score (described below) of > 3 and < 9 (possible range, 0-10)

boolean

C0409931 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])

Item

were normally active, not bedridden or confined to a wheelchair, and were able to walk 30 meters without the aid of a walker, crutches or cane

boolean

C0205177 (UMLS CUI [1])
C0741453 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0241735 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C2712089 (UMLS CUI [4,1])
C0012751 (UMLS CUI [4,2])
C1806781 (UMLS CUI [4,3])
C0332291 (UMLS CUI [5,1])
C0043016 (UMLS CUI [5,2])
C0332291 (UMLS CUI [6,1])
C0010397 (UMLS CUI [6,2])
C0332291 (UMLS CUI [7,1])
C0006856 (UMLS CUI [7,2])

NSAIDs Discontinue Willing | Analgesics Discontinue Willing

Item

were willing to discontinue all nonsteroidal anti-inflammatory drugs (nsaids) or other analgesic medication (except for rescue medication) for the duration of the study

boolean

C0003211 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0002771 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])

Physical therapy Absent | Shoes Modification Absent | Orthotics Absent

Item

did not receive physical therapy or trial of shoe modifications or orthotics during the study period

boolean

C0949766 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0036988 (UMLS CUI [2,1])
C3840684 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0029365 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Pregnancy | Breast Feeding

Item

pregnant and lactating women

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Osteoarthritis of ankle Bilateral | Treatment required for Both ankles

Item

bilateral ankle oa requiring treatment of both ankles

boolean

C0409931 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2,1])
C0230456 (UMLS CUI [2,2])

Chronic ankle instability

Item

chronic ankle instability

boolean

C3840097 (UMLS CUI [1])

Lower leg Trauma | Exception Ankle

Item

lower leg trauma other than within the ankle

boolean

C1140621 (UMLS CUI [1,1])
C3714660 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003086 (UMLS CUI [2,2])

Orthopedic Surgical Procedure Spine | Orthopedic Surgical Procedure Hip | Orthopedic Surgical Procedure Knee

Item

previous orthopedic surgery on the spine, hip or knee

boolean

C1136201 (UMLS CUI [1,1])
C0037949 (UMLS CUI [1,2])
C1136201 (UMLS CUI [2,1])
C0019552 (UMLS CUI [2,2])
C1136201 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])

Joint infection Foot | Joint infection Ankle

Item

presence of active joint infections of foot or ankle

boolean

C0157749 (UMLS CUI [1,1])
C0016504 (UMLS CUI [1,2])
C0157749 (UMLS CUI [2,1])
C0003086 (UMLS CUI [2,2])

Operative procedure on ankle | Ankle arthroscopy

Item

previous surgery or arthroscopy on the ankle within 12 months

boolean

C0188412 (UMLS CUI [1])
C0188624 (UMLS CUI [2])

Intraarticular steroid injection Ankle Treated | Hyaluronic Acid Injection Ankle Treated

Item

intraarticular steroid or ha injection in the treated ankle within the past 6 months

boolean

C2064783 (UMLS CUI [1,1])
C0003086 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C0020196 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C0003086 (UMLS CUI [2,3])
C1522326 (UMLS CUI [2,4])

Anticoagulants | Immunosuppressive Agents

Item

treatment with anticoagulants or immunosuppressives

boolean

C0003280 (UMLS CUI [1])
C0021081 (UMLS CUI [2])

Rheumatoid Arthritis | Gout | Inflammatory Arthropathy

Item

history of rheumatoid arthritis, gout, or any other inflammatory arthropathy

boolean

C0003873 (UMLS CUI [1])
C0018099 (UMLS CUI [2])
C0003864 (UMLS CUI [3])

Hypersensitivity Protein Avian

Item

history of avian protein allergy

boolean

C0020517 (UMLS CUI [1,1])
C0033684 (UMLS CUI [1,2])
C0005595 (UMLS CUI [1,3])

Comorbidity Interferes with Clinical assessment | Neoplasms | Diabetes Mellitus | Paresis | Trauma

Item

presence of other comorbidity (neoplasm, diabetes mellitus, paresis, recent trauma, etc) or poor health status that would interfere with the clinical assessments during the study

boolean

C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C4534461 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0030552 (UMLS CUI [4])
C3714660 (UMLS CUI [5])

Voltar ao início da página

ID

Descrição

Link

Palavras-chave

Versões (1)

Titular dos direitos

Transferido a

DOI

Licença

Comentários do modelo :

Comentários do grupo de itens para :

Comentários do item para :

Eligibility Osteoarthritis NCT00918736