ID

15765

Beschrijving

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

Trefwoorden

Versies (1)
  1. 12-06-16 12-06-16 -
Geüploaded op

12 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee NCT02370823

Engels

Eligibility Osteoarthritis, Knee NCT02370823

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Informed consent

Datatype

boolean

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

Osteoarthritis, Knee Unilateral | Age

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Physical Examination Consistent with Degenerative polyarthritis Knee joint

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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.)
Beschrijving

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

Datatype

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
Beschrijving

Knee Unaffected | Range of motion Normal

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Knee Unaffected | acute knee injury Absent

Datatype

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
Beschrijving

Independent | Ambulatory | Compliance behavior Study Protocol

Datatype

boolean

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

Exclusion Criteria

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

Injection Knee

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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)
Beschrijving

Disorder of lumbar spine Symptomatic | Radicular pain

Datatype

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).
Beschrijving

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

Datatype

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
Beschrijving

Medical contraindication Magnetic Resonance Imaging

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Condition Worker Compensation

Datatype

boolean

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

Litigation Health Related | Involvement with

Datatype

boolean

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

Pregnancy

Datatype

boolean

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

Blood Coagulation Disorders

Datatype

boolean

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

Anticoagulants | Immunosuppressive Agents

Datatype

boolean

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

Hypersensitivity Investigational New Drugs | intolerance to Investigational New Drugs

Datatype

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
Beschrijving

Opioids chronic | Use of

Datatype

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
Beschrijving

Drug abuse

Datatype

boolean

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

Condition Study Subject Participation Status Limited

Datatype

boolean

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

Eligibility Osteoarthritis, Knee NCT02370823

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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