ID

37692

Description

Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01931007

Link

https://clinicaltrials.gov/show/NCT01931007

Keywords

Versions (1)
  1. 8/16/19 8/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Bilateral Primary Osteoarthritis of Knee NCT01931007

English

Eligibility Bilateral Primary Osteoarthritis of Knee NCT01931007

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female subjects are both eligible
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
2. subjects must be 18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. subjects must have bilateral oa and pain in both knees.
Description

Bilateral primary osteoarthritis of knee | Bilateral knee pain

Data type

boolean

Alias
UMLS CUI [1]
C2893930
UMLS CUI [2]
C2220048
4. osteoarthritis may be primary or secondary. knees must have kellgren-lawrence grades 1-3.
Description

Primary osteoarthritis | Secondary osteoarthritis | Knees Kellgren-Lawrence score

Data type

boolean

Alias
UMLS CUI [1]
C0409952
UMLS CUI [2]
C2732281
UMLS CUI [3,1]
C0022742
UMLS CUI [3,2]
C3177117
5. subjects must have previously tried 6 weeks of one of the following conservative treatments activity modification, weight loss; physical therapy, anti-inflammatory or injection therapy
Description

Conservative Treatment Quantity Attempted | Activity Modification | Weight reduction regimen | Physical therapy | Antiinflammatory therapy | Injection therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0459914
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1516084
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C3840684
UMLS CUI [3]
C0311130
UMLS CUI [4]
C0949766
UMLS CUI [5]
C1096024
UMLS CUI [6]
C0444472
6. patients can provide written informed consent after the nature of the study is fully explained
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
Description

Hematology finding abnormal | Serum chemistry test Abnormal | Urine screening abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0475182
UMLS CUI [2,1]
C0236613
UMLS CUI [2,2]
C0205161
UMLS CUI [3]
C0438142
2. patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
Description

Anti-Inflammatory Agents | Anti-Inflammatory Agents Non-Prescription | Phytotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0003209
UMLS CUI [2,1]
C0003209
UMLS CUI [2,2]
C0013231
UMLS CUI [3]
C0242388
3. patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry.
Description

Antirheumatic Agents | Methotrexate | Antimetabolites

Data type

boolean

Alias
UMLS CUI [1]
C0003191
UMLS CUI [2]
C0025677
UMLS CUI [3]
C0003376
4. patients receiving injections to the treated knee within 2 months prior to study entry.
Description

Injection Knee Treated

Data type

boolean

Alias
UMLS CUI [1,1]
C1533685
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C1522326
5. patients who are pregnant or currently breast-feeding children.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
Description

Systemic disease Knee | Rheumatic disorder Knee | Inflammatory disorder Knee | Chondrocalcinosis | Hemochromatosis | Arthritis | Knee arthropathy Associated with Paget's disease-femur | Knee arthropathy Associated with Paget's disease-tibia | Ochronosis | Hemophilic arthropathy | Arthritis, Infectious | Charcot Knee joint | Villonodular synovitis | Chondromatosis, Synovial

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0022742
UMLS CUI [2,1]
C3495832
UMLS CUI [2,2]
C0022742
UMLS CUI [3,1]
C1290884
UMLS CUI [3,2]
C0022742
UMLS CUI [4]
C0221621
UMLS CUI [5]
C0018995
UMLS CUI [6]
C0003864
UMLS CUI [7,1]
C2105246
UMLS CUI [7,2]
C0332281
UMLS CUI [7,3]
C0410459
UMLS CUI [8,1]
C2105246
UMLS CUI [8,2]
C0332281
UMLS CUI [8,3]
C0410457
UMLS CUI [9]
C0028817
UMLS CUI [10]
C0263725
UMLS CUI [11]
C0003869
UMLS CUI [12,1]
C1398636
UMLS CUI [12,2]
C0022745
UMLS CUI [13]
C0158168
UMLS CUI [14]
C0008476
7. patients with ongoing infectious disease, including hiv and hepatitis
Description

Communicable Disease | HIV Infection | Hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019158
8. patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
Description

Cardiovascular Disease | Kidney Disease | Liver disease | Endocrine System Disease | Malignant Neoplasms | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0014130
UMLS CUI [5]
C0006826
UMLS CUI [6]
C0011849
9. patients participating in a study of an experimental drug or medical device within 30 days of study entry.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Similar models

Eligibility Bilateral Primary Osteoarthritis of Knee NCT01931007

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
1. male and female subjects are both eligible
boolean
C0079399 (UMLS CUI [1])
Age
Item
2. subjects must be 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Bilateral primary osteoarthritis of knee | Bilateral knee pain
Item
3. subjects must have bilateral oa and pain in both knees.
boolean
C2893930 (UMLS CUI [1])
C2220048 (UMLS CUI [2])
Primary osteoarthritis | Secondary osteoarthritis | Knees Kellgren-Lawrence score
Item
4. osteoarthritis may be primary or secondary. knees must have kellgren-lawrence grades 1-3.
boolean
C0409952 (UMLS CUI [1])
C2732281 (UMLS CUI [2])
C0022742 (UMLS CUI [3,1])
C3177117 (UMLS CUI [3,2])
Conservative Treatment Quantity Attempted | Activity Modification | Weight reduction regimen | Physical therapy | Antiinflammatory therapy | Injection therapy
Item
5. subjects must have previously tried 6 weeks of one of the following conservative treatments activity modification, weight loss; physical therapy, anti-inflammatory or injection therapy
boolean
C0459914 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1516084 (UMLS CUI [1,3])
C0026606 (UMLS CUI [2,1])
C3840684 (UMLS CUI [2,2])
C0311130 (UMLS CUI [3])
C0949766 (UMLS CUI [4])
C1096024 (UMLS CUI [5])
C0444472 (UMLS CUI [6])
Informed Consent
Item
6. patients can provide written informed consent after the nature of the study is fully explained
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hematology finding abnormal | Serum chemistry test Abnormal | Urine screening abnormal
Item
1. patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
boolean
C0475182 (UMLS CUI [1])
C0236613 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0438142 (UMLS CUI [3])
Anti-Inflammatory Agents | Anti-Inflammatory Agents Non-Prescription | Phytotherapy
Item
2. patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
boolean
C0003209 (UMLS CUI [1])
C0003209 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0242388 (UMLS CUI [3])
Antirheumatic Agents | Methotrexate | Antimetabolites
Item
3. patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry.
boolean
C0003191 (UMLS CUI [1])
C0025677 (UMLS CUI [2])
C0003376 (UMLS CUI [3])
Injection Knee Treated
Item
4. patients receiving injections to the treated knee within 2 months prior to study entry.
boolean
C1533685 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
5. patients who are pregnant or currently breast-feeding children.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic disease Knee | Rheumatic disorder Knee | Inflammatory disorder Knee | Chondrocalcinosis | Hemochromatosis | Arthritis | Knee arthropathy Associated with Paget's disease-femur | Knee arthropathy Associated with Paget's disease-tibia | Ochronosis | Hemophilic arthropathy | Arthritis, Infectious | Charcot Knee joint | Villonodular synovitis | Chondromatosis, Synovial
Item
6. patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
boolean
C0442893 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C3495832 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C1290884 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])
C0221621 (UMLS CUI [4])
C0018995 (UMLS CUI [5])
C0003864 (UMLS CUI [6])
C2105246 (UMLS CUI [7,1])
C0332281 (UMLS CUI [7,2])
C0410459 (UMLS CUI [7,3])
C2105246 (UMLS CUI [8,1])
C0332281 (UMLS CUI [8,2])
C0410457 (UMLS CUI [8,3])
C0028817 (UMLS CUI [9])
C0263725 (UMLS CUI [10])
C0003869 (UMLS CUI [11])
C1398636 (UMLS CUI [12,1])
C0022745 (UMLS CUI [12,2])
C0158168 (UMLS CUI [13])
C0008476 (UMLS CUI [14])
Communicable Disease | HIV Infection | Hepatitis
Item
7. patients with ongoing infectious disease, including hiv and hepatitis
boolean
C0009450 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
Cardiovascular Disease | Kidney Disease | Liver disease | Endocrine System Disease | Malignant Neoplasms | Diabetes Mellitus
Item
8. patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
boolean
C0007222 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C0011849 (UMLS CUI [6])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
9. patients participating in a study of an experimental drug or medical device within 30 days of study entry.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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