ID

33783

Description

Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA); ODM derived from: https://clinicaltrials.gov/show/NCT01773226

Link

https://clinicaltrials.gov/show/NCT01773226

Keywords

  1. 12/27/18 12/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 27, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Gonarthrosis NCT01773226

Eligibility Gonarthrosis NCT01773226

Eligibility Criteria
Description

Eligibility Criteria

male or female ≥40 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
a standing radiograph of the knee showing a kellgren grade of 2 or 3
Description

Radiography of knee Standing Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1,1]
C0845957
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C3177117
frequency of knee pain on most days over the last month.
Description

Knee pain Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0439603
diagnosis of unilateral knee oa
Description

Unilateral primary osteoarthritis of knee

Data type

boolean

Alias
UMLS CUI [1]
C2893932
body mass index (bmi) ≤40 kg/m2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
failed conservative oa therapy.
Description

Conservative Treatment failed Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0459914
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C0029408
signed an independent ethics committee (iec)-approved informed consent form (icf).
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study.
Description

Avoidance Therapy Topical Pain | Avoidance Intraarticular Corticosteroid | Avoidance Viscosupplementation

Data type

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1522168
UMLS CUI [1,4]
C0030193
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C4054701
UMLS CUI [3,1]
C0870186
UMLS CUI [3,2]
C2350507
willingness to abstain from systemic pain medications except rescue medication.
Description

Avoidance Pharmaceutical Preparations Systemic Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205373
UMLS CUI [1,4]
C0030193

Similar models

Eligibility Gonarthrosis NCT01773226

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Age
Item
male or female ≥40 years.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
boolean
C0525058 (UMLS CUI [1])
Radiography of knee Standing Kellgren-Lawrence score
Item
a standing radiograph of the knee showing a kellgren grade of 2 or 3
boolean
C0845957 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C3177117 (UMLS CUI [1,3])
Knee pain Frequency
Item
frequency of knee pain on most days over the last month.
boolean
C0231749 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Unilateral primary osteoarthritis of knee
Item
diagnosis of unilateral knee oa
boolean
C2893932 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) ≤40 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Conservative Treatment failed Osteoarthritis
Item
failed conservative oa therapy.
boolean
C0459914 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
Informed Consent
Item
signed an independent ethics committee (iec)-approved informed consent form (icf).
boolean
C0021430 (UMLS CUI [1])
Avoidance Therapy Topical Pain | Avoidance Intraarticular Corticosteroid | Avoidance Viscosupplementation
Item
willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study.
boolean
C0870186 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1522168 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,4])
C0870186 (UMLS CUI [2,1])
C4054701 (UMLS CUI [2,2])
C0870186 (UMLS CUI [3,1])
C2350507 (UMLS CUI [3,2])
Avoidance Pharmaceutical Preparations Systemic Pain
Item
willingness to abstain from systemic pain medications except rescue medication.
boolean
C0870186 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,4])

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