Eligibility Osteoarthritis, Knee NCT02370823

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StudyEvent: Eligibility
1. Eligibility Osteoarthritis, Knee NCT02370823

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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])

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])

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])

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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Eligibility Osteoarthritis, Knee NCT02370823