0 Avaliações

ID

15765

Descrição

A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT02370823

Link

https://clinicaltrials.gov/show/NCT02370823

Palavras-chave

  1. 12/06/2016 12/06/2016 -
Transferido a

12 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Osteoarthritis, Knee NCT02370823

    Eligibility Osteoarthritis, Knee NCT02370823

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. voluntary signature of the irb approved informed consent
    Descrição

    Informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    2. unilateral osteoarthritic male or female ages 35-85
    Descrição

    Osteoarthritis, Knee Unilateral | Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0409959
    UMLS CUI [1,2]
    C0205092
    UMLS CUI [2]
    C0001779
    3. pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in one knee joint
    Descrição

    Knee Affected | Pain | Swelling | functional disability | Degenerative polyarthritis Knee joint

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0022742
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [2]
    C0030193
    UMLS CUI [3]
    C0038999
    UMLS CUI [4]
    C0872173
    UMLS CUI [5,1]
    C0029408
    UMLS CUI [5,2]
    C0022745
    4. physical examination consistent with osteoarthritis in one knee joint
    Descrição

    Physical Examination Consistent with Degenerative polyarthritis Knee joint

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0332290
    UMLS CUI [1,3]
    C0029408
    UMLS CUI [1,4]
    C0022745
    5. restricted range of motion of the affected knee (<135 degrees in flexion and/or >0 degrees of extension)
    Descrição

    Knee Affected | Range of motion Restricted | Knee flexion | extension of knee

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0022742
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [2,1]
    C2607871
    UMLS CUI [2,2]
    C0443288
    UMLS CUI [3]
    C0240114
    UMLS CUI [4]
    C2237139
    6. kellgren-lawrence grade 2 or greater knee osteoarthritis with diagnostic mr imaging of the affected knee showing osteoarthritis
    Descrição

    Osteoarthritis, Knee | Magnetic Resonance Imaging | Kellgren-Lawrence score

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0409959
    UMLS CUI [2]
    C0024485
    UMLS CUI [3]
    C3177117
    7. limited knee effusion in osteoarthritic knee (i.e. not more than 20 ml of visible joint fluid on ultrasound examination of the knee.)
    Descrição

    Osteoarthritis, Knee | grade of knee effusion Limited | Synovial Fluid Visible | Knee Ultrasonography

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0409959
    UMLS CUI [2,1]
    C2109494
    UMLS CUI [2,2]
    C0439801
    UMLS CUI [3,1]
    C0039097
    UMLS CUI [3,2]
    C0205379
    UMLS CUI [4,1]
    C0022742
    UMLS CUI [4,2]
    C0041618
    8. normal range of motion of the unaffected knee
    Descrição

    Knee Unaffected | Range of motion Normal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0022742
    UMLS CUI [1,2]
    C2986417
    UMLS CUI [2,1]
    C2607871
    UMLS CUI [2,2]
    C0205307
    9. no sign of pain, swelling, and/or functional disability of the unaffected knee
    Descrição

    Knee Unaffected | Pain Absent | Swelling Absent | functional disability Absent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0022742
    UMLS CUI [1,2]
    C2986417
    UMLS CUI [2,1]
    C0030193
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3,1]
    C0038999
    UMLS CUI [3,2]
    C0332197
    UMLS CUI [4,1]
    C0872173
    UMLS CUI [4,2]
    C0332197
    10. no history of acute injury in the unaffected knee
    Descrição

    Knee Unaffected | acute knee injury Absent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0022742
    UMLS CUI [1,2]
    C2986417
    UMLS CUI [2,1]
    C0850518
    UMLS CUI [2,2]
    C0332197
    11. is independent, ambulatory, and can comply with all post-operative evaluations and visits
    Descrição

    Independent | Ambulatory | Compliance behavior Study Protocol

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1299583
    UMLS CUI [2]
    C0439841
    UMLS CUI [3,1]
    C1321605
    UMLS CUI [3,2]
    C2348563
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. knee injections of any type within 6 months prior to the study.
    Descrição

    Injection Knee

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1533685
    UMLS CUI [1,2]
    C0022742
    2. inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
    Descrição

    inflammatory joint disease | Arthropathy Autoimmune | Lower Extremity Pathological aspects | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Arthritis, Psoriatic | Polymyalgia | Polymyositis | Gout | Pseudogout

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0683381
    UMLS CUI [2,1]
    C0022408
    UMLS CUI [2,2]
    C0443146
    UMLS CUI [3,1]
    C0023216
    UMLS CUI [3,2]
    C0205469
    UMLS CUI [4]
    C0003873
    UMLS CUI [5]
    C0024141
    UMLS CUI [6]
    C0003872
    UMLS CUI [7]
    C0521516
    UMLS CUI [8]
    C0085655
    UMLS CUI [9]
    C0018099
    UMLS CUI [10]
    C0033802
    3. quinolone or statin induced myopathy/tendinopathy
    Descrição

    Myopathy Quinolone induced | Tendinopathy Quinolone induced | Myopathy statin induced | Tendinopathy statin induced

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0026848
    UMLS CUI [1,2]
    C0034428
    UMLS CUI [1,3]
    C0007994
    UMLS CUI [2,1]
    C1568272
    UMLS CUI [2,2]
    C0034428
    UMLS CUI [2,3]
    C0007994
    UMLS CUI [3,1]
    C0026848
    UMLS CUI [3,2]
    C0360714
    UMLS CUI [3,3]
    C0007994
    UMLS CUI [4,1]
    C1568272
    UMLS CUI [4,2]
    C0360714
    UMLS CUI [4,3]
    C0007994
    4. symptomatic lumbar spine pathology (e.g. radicular pain)
    Descrição

    Disorder of lumbar spine Symptomatic | Radicular pain

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1290147
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [2]
    C0278147
    5. severe neurogenic inflammation of the cutaneous nerves about the knee or thigh (i.e. evidence of complex regional pain syndrome or central sensitization with allodynia present on exam).
    Descrição

    Knee Nerve Cutaneous | Neurogenic Inflammation Severe | thigh Nerve Cutaneous | Neurogenic Inflammation Severe | Complex Regional Pain Syndromes | Central Nervous System Sensitization | Allodynia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0022742
    UMLS CUI [1,2]
    C0027740
    UMLS CUI [1,3]
    C0221912
    UMLS CUI [2,1]
    C0600467
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [3,1]
    C1281586
    UMLS CUI [3,2]
    C0027740
    UMLS CUI [3,3]
    C0221912
    UMLS CUI [4,1]
    C0600467
    UMLS CUI [4,2]
    C0205082
    UMLS CUI [5]
    C0458219
    UMLS CUI [6]
    C2938905
    UMLS CUI [7]
    C0458247
    6. contraindications for mri
    Descrição

    Medical contraindication Magnetic Resonance Imaging

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0024485
    7. tested positive or has been treated for a malignancy in the past five years or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
    Descrição

    Malignant Neoplasms Test Positive | Therapeutic procedure Malignant Neoplasms | Suspected malignancy | Therapeutic radiology procedure Malignant Neoplasms | Chemotherapy Malignant Neoplasms | Injection site

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0392366
    UMLS CUI [1,3]
    C1446409
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0006826
    UMLS CUI [3]
    C0581833
    UMLS CUI [4,1]
    C1522449
    UMLS CUI [4,2]
    C0006826
    UMLS CUI [5,1]
    C0392920
    UMLS CUI [5,2]
    C0006826
    UMLS CUI [6]
    C2700396
    8. condition represents a worker's compensation case
    Descrição

    Condition Worker Compensation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C0043233
    9. currently involved in a health-related litigation procedure
    Descrição

    Litigation Health Related | Involvement with

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0079706
    UMLS CUI [1,2]
    C0018684
    UMLS CUI [1,3]
    C0439849
    UMLS CUI [2]
    C1314939
    10. is pregnant
    Descrição

    Pregnancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    11. bleeding disorders
    Descrição

    Blood Coagulation Disorders

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005779
    12. currently taking anticoagulant or immunosuppressive medication
    Descrição

    Anticoagulants | Immunosuppressive Agents

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0003280
    UMLS CUI [2]
    C0021081
    13. allergy or intolerance to study medication
    Descrição

    Hypersensitivity Investigational New Drugs | intolerance to Investigational New Drugs

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [2,1]
    C1744706
    UMLS CUI [2,2]
    C0013230
    14. use of chronic opioid
    Descrição

    Opioids chronic | Use of

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0242402
    UMLS CUI [1,2]
    C0205191
    UMLS CUI [2]
    C1524063
    15. documented history of drug abuse within six months of treatment
    Descrição

    Drug abuse

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013146
    18) any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
    Descrição

    Condition Study Subject Participation Status Limited

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0439801

    Similar models

    Eligibility Osteoarthritis, Knee NCT02370823

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed consent
    Item
    1. voluntary signature of the irb approved informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Osteoarthritis, Knee Unilateral | Age
    Item
    2. unilateral osteoarthritic male or female ages 35-85
    boolean
    C0409959 (UMLS CUI [1,1])
    C0205092 (UMLS CUI [1,2])
    C0001779 (UMLS CUI [2])
    Knee Affected | Pain | Swelling | functional disability | Degenerative polyarthritis Knee joint
    Item
    3. pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in one knee joint
    boolean
    C0022742 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [2])
    C0038999 (UMLS CUI [3])
    C0872173 (UMLS CUI [4])
    C0029408 (UMLS CUI [5,1])
    C0022745 (UMLS CUI [5,2])
    Physical Examination Consistent with Degenerative polyarthritis Knee joint
    Item
    4. physical examination consistent with osteoarthritis in one knee joint
    boolean
    C0031809 (UMLS CUI [1,1])
    C0332290 (UMLS CUI [1,2])
    C0029408 (UMLS CUI [1,3])
    C0022745 (UMLS CUI [1,4])
    Knee Affected | Range of motion Restricted | Knee flexion | extension of knee
    Item
    5. restricted range of motion of the affected knee (<135 degrees in flexion and/or >0 degrees of extension)
    boolean
    C0022742 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C2607871 (UMLS CUI [2,1])
    C0443288 (UMLS CUI [2,2])
    C0240114 (UMLS CUI [3])
    C2237139 (UMLS CUI [4])
    Osteoarthritis, Knee | Magnetic Resonance Imaging | Kellgren-Lawrence score
    Item
    6. kellgren-lawrence grade 2 or greater knee osteoarthritis with diagnostic mr imaging of the affected knee showing osteoarthritis
    boolean
    C0409959 (UMLS CUI [1])
    C0024485 (UMLS CUI [2])
    C3177117 (UMLS CUI [3])
    Osteoarthritis, Knee | grade of knee effusion Limited | Synovial Fluid Visible | Knee Ultrasonography
    Item
    7. limited knee effusion in osteoarthritic knee (i.e. not more than 20 ml of visible joint fluid on ultrasound examination of the knee.)
    boolean
    C0409959 (UMLS CUI [1])
    C2109494 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    C0039097 (UMLS CUI [3,1])
    C0205379 (UMLS CUI [3,2])
    C0022742 (UMLS CUI [4,1])
    C0041618 (UMLS CUI [4,2])
    Knee Unaffected | Range of motion Normal
    Item
    8. normal range of motion of the unaffected knee
    boolean
    C0022742 (UMLS CUI [1,1])
    C2986417 (UMLS CUI [1,2])
    C2607871 (UMLS CUI [2,1])
    C0205307 (UMLS CUI [2,2])
    Knee Unaffected | Pain Absent | Swelling Absent | functional disability Absent
    Item
    9. no sign of pain, swelling, and/or functional disability of the unaffected knee
    boolean
    C0022742 (UMLS CUI [1,1])
    C2986417 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0038999 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    C0872173 (UMLS CUI [4,1])
    C0332197 (UMLS CUI [4,2])
    Knee Unaffected | acute knee injury Absent
    Item
    10. no history of acute injury in the unaffected knee
    boolean
    C0022742 (UMLS CUI [1,1])
    C2986417 (UMLS CUI [1,2])
    C0850518 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Independent | Ambulatory | Compliance behavior Study Protocol
    Item
    11. is independent, ambulatory, and can comply with all post-operative evaluations and visits
    boolean
    C1299583 (UMLS CUI [1])
    C0439841 (UMLS CUI [2])
    C1321605 (UMLS CUI [3,1])
    C2348563 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Injection Knee
    Item
    1. knee injections of any type within 6 months prior to the study.
    boolean
    C1533685 (UMLS CUI [1,1])
    C0022742 (UMLS CUI [1,2])
    inflammatory joint disease | Arthropathy Autoimmune | Lower Extremity Pathological aspects | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Arthritis, Psoriatic | Polymyalgia | Polymyositis | Gout | Pseudogout
    Item
    2. inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
    boolean
    C0683381 (UMLS CUI [1])
    C0022408 (UMLS CUI [2,1])
    C0443146 (UMLS CUI [2,2])
    C0023216 (UMLS CUI [3,1])
    C0205469 (UMLS CUI [3,2])
    C0003873 (UMLS CUI [4])
    C0024141 (UMLS CUI [5])
    C0003872 (UMLS CUI [6])
    C0521516 (UMLS CUI [7])
    C0085655 (UMLS CUI [8])
    C0018099 (UMLS CUI [9])
    C0033802 (UMLS CUI [10])
    Myopathy Quinolone induced | Tendinopathy Quinolone induced | Myopathy statin induced | Tendinopathy statin induced
    Item
    3. quinolone or statin induced myopathy/tendinopathy
    boolean
    C0026848 (UMLS CUI [1,1])
    C0034428 (UMLS CUI [1,2])
    C0007994 (UMLS CUI [1,3])
    C1568272 (UMLS CUI [2,1])
    C0034428 (UMLS CUI [2,2])
    C0007994 (UMLS CUI [2,3])
    C0026848 (UMLS CUI [3,1])
    C0360714 (UMLS CUI [3,2])
    C0007994 (UMLS CUI [3,3])
    C1568272 (UMLS CUI [4,1])
    C0360714 (UMLS CUI [4,2])
    C0007994 (UMLS CUI [4,3])
    Disorder of lumbar spine Symptomatic | Radicular pain
    Item
    4. symptomatic lumbar spine pathology (e.g. radicular pain)
    boolean
    C1290147 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C0278147 (UMLS CUI [2])
    Knee Nerve Cutaneous | Neurogenic Inflammation Severe | thigh Nerve Cutaneous | Neurogenic Inflammation Severe | Complex Regional Pain Syndromes | Central Nervous System Sensitization | Allodynia
    Item
    5. severe neurogenic inflammation of the cutaneous nerves about the knee or thigh (i.e. evidence of complex regional pain syndrome or central sensitization with allodynia present on exam).
    boolean
    C0022742 (UMLS CUI [1,1])
    C0027740 (UMLS CUI [1,2])
    C0221912 (UMLS CUI [1,3])
    C0600467 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C1281586 (UMLS CUI [3,1])
    C0027740 (UMLS CUI [3,2])
    C0221912 (UMLS CUI [3,3])
    C0600467 (UMLS CUI [4,1])
    C0205082 (UMLS CUI [4,2])
    C0458219 (UMLS CUI [5])
    C2938905 (UMLS CUI [6])
    C0458247 (UMLS CUI [7])
    Medical contraindication Magnetic Resonance Imaging
    Item
    6. contraindications for mri
    boolean
    C1301624 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    Malignant Neoplasms Test Positive | Therapeutic procedure Malignant Neoplasms | Suspected malignancy | Therapeutic radiology procedure Malignant Neoplasms | Chemotherapy Malignant Neoplasms | Injection site
    Item
    7. tested positive or has been treated for a malignancy in the past five years or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
    boolean
    C0006826 (UMLS CUI [1,1])
    C0392366 (UMLS CUI [1,2])
    C1446409 (UMLS CUI [1,3])
    C0087111 (UMLS CUI [2,1])
    C0006826 (UMLS CUI [2,2])
    C0581833 (UMLS CUI [3])
    C1522449 (UMLS CUI [4,1])
    C0006826 (UMLS CUI [4,2])
    C0392920 (UMLS CUI [5,1])
    C0006826 (UMLS CUI [5,2])
    C2700396 (UMLS CUI [6])
    Condition Worker Compensation
    Item
    8. condition represents a worker's compensation case
    boolean
    C0348080 (UMLS CUI [1,1])
    C0043233 (UMLS CUI [1,2])
    Litigation Health Related | Involvement with
    Item
    9. currently involved in a health-related litigation procedure
    boolean
    C0079706 (UMLS CUI [1,1])
    C0018684 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    C1314939 (UMLS CUI [2])
    Pregnancy
    Item
    10. is pregnant
    boolean
    C0032961 (UMLS CUI [1])
    Blood Coagulation Disorders
    Item
    11. bleeding disorders
    boolean
    C0005779 (UMLS CUI [1])
    Anticoagulants | Immunosuppressive Agents
    Item
    12. currently taking anticoagulant or immunosuppressive medication
    boolean
    C0003280 (UMLS CUI [1])
    C0021081 (UMLS CUI [2])
    Hypersensitivity Investigational New Drugs | intolerance to Investigational New Drugs
    Item
    13. allergy or intolerance to study medication
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C1744706 (UMLS CUI [2,1])
    C0013230 (UMLS CUI [2,2])
    Opioids chronic | Use of
    Item
    14. use of chronic opioid
    boolean
    C0242402 (UMLS CUI [1,1])
    C0205191 (UMLS CUI [1,2])
    C1524063 (UMLS CUI [2])
    Drug abuse
    Item
    15. documented history of drug abuse within six months of treatment
    boolean
    C0013146 (UMLS CUI [1])
    Condition Study Subject Participation Status Limited
    Item
    18) any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
    boolean
    C0348080 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])

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