ID

31285

Beschrijving

Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00918736

Link

https://clinicaltrials.gov/show/NCT00918736

Trefwoorden

Versies (1)
  1. 08-08-18 08-08-18 -
Houder van rechten

See clinicaltrials.gov

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8 augustus 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00918736

Engels

Eligibility Osteoarthritis NCT00918736

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Beschrijving

Age | Ankle pain Unilateral Duration | Conservative Treatment Benefit Lacking | Rest | Physical therapy | Orthoses | Analgesics | Adverse reaction to drug Side effects

Datatype

boolean

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

Radiography of ankle Kellgren-Lawrence score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0203281
UMLS CUI [1,2]
C3177117
had a current total aos score (described below) of > 3 and < 9 (possible range, 0-10)
Beschrijving

Ankle Osteoarthritis Score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0409931
UMLS CUI [1,2]
C0449820
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
Beschrijving

Active | Bedridden Absent | WHEELCHAIR CONFINEMENT Absent | Able to walk Distance Short | Independent of Walkers | Independent of Crutches | Independent of Canes

Datatype

boolean

Alias
UMLS CUI [1]
C0205177
UMLS CUI [2,1]
C0741453
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0241735
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C2712089
UMLS CUI [4,2]
C0012751
UMLS CUI [4,3]
C1806781
UMLS CUI [5,1]
C0332291
UMLS CUI [5,2]
C0043016
UMLS CUI [6,1]
C0332291
UMLS CUI [6,2]
C0010397
UMLS CUI [7,1]
C0332291
UMLS CUI [7,2]
C0006856
were willing to discontinue all nonsteroidal anti-inflammatory drugs (nsaids) or other analgesic medication (except for rescue medication) for the duration of the study
Beschrijving

NSAIDs Discontinue Willing | Analgesics Discontinue Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0002771
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0600109
did not receive physical therapy or trial of shoe modifications or orthotics during the study period
Beschrijving

Physical therapy Absent | Shoes Modification Absent | Orthotics Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0949766
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0036988
UMLS CUI [2,2]
C3840684
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0029365
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant and lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
bilateral ankle oa requiring treatment of both ankles
Beschrijving

Osteoarthritis of ankle Bilateral | Treatment required for Both ankles

Datatype

boolean

Alias
UMLS CUI [1,1]
C0409931
UMLS CUI [1,2]
C0238767
UMLS CUI [2,1]
C0332121
UMLS CUI [2,2]
C0230456
chronic ankle instability
Beschrijving

Chronic ankle instability

Datatype

boolean

Alias
UMLS CUI [1]
C3840097
lower leg trauma other than within the ankle
Beschrijving

Lower leg Trauma | Exception Ankle

Datatype

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C3714660
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003086
previous orthopedic surgery on the spine, hip or knee
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C1136201
UMLS CUI [1,2]
C0037949
UMLS CUI [2,1]
C1136201
UMLS CUI [2,2]
C0019552
UMLS CUI [3,1]
C1136201
UMLS CUI [3,2]
C0022742
presence of active joint infections of foot or ankle
Beschrijving

Joint infection Foot | Joint infection Ankle

Datatype

boolean

Alias
UMLS CUI [1,1]
C0157749
UMLS CUI [1,2]
C0016504
UMLS CUI [2,1]
C0157749
UMLS CUI [2,2]
C0003086
previous surgery or arthroscopy on the ankle within 12 months
Beschrijving

Operative procedure on ankle | Ankle arthroscopy

Datatype

boolean

Alias
UMLS CUI [1]
C0188412
UMLS CUI [2]
C0188624
intraarticular steroid or ha injection in the treated ankle within the past 6 months
Beschrijving

Intraarticular steroid injection Ankle Treated | Hyaluronic Acid Injection Ankle Treated

Datatype

boolean

Alias
UMLS CUI [1,1]
C2064783
UMLS CUI [1,2]
C0003086
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C0020196
UMLS CUI [2,2]
C1828121
UMLS CUI [2,3]
C0003086
UMLS CUI [2,4]
C1522326
treatment with anticoagulants or immunosuppressives
Beschrijving

Anticoagulants | Immunosuppressive Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C0021081
history of rheumatoid arthritis, gout, or any other inflammatory arthropathy
Beschrijving

Rheumatoid Arthritis | Gout | Inflammatory Arthropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0018099
UMLS CUI [3]
C0003864
history of avian protein allergy
Beschrijving

Hypersensitivity Protein Avian

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0033684
UMLS CUI [1,3]
C0005595
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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C4534461
UMLS CUI [2]
C0027651
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0030552
UMLS CUI [5]
C3714660
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Similar models

Eligibility Osteoarthritis NCT00918736

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Ankle pain Unilateral Duration | Conservative Treatment Benefit Lacking | Rest | Physical therapy | Orthoses | Analgesics | Adverse reaction to drug Side effects
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])
Active | Bedridden Absent | WHEELCHAIR CONFINEMENT Absent | Able to walk Distance Short | Independent of Walkers | Independent of Crutches | Independent of Canes
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])
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])
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