Eligibility Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery NCT02491281

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age | Good health Medical History | Good health Physical Examination | Good health Vital signs | Good health Electrocardiography | Good health Laboratory Procedures
Item
male and female patients age 50 to 75 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
boolean
C0001779 (UMLS CUI [1])
C3813622 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C3813622 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C3813622 (UMLS CUI [4,1])
C0518766 (UMLS CUI [4,2])
C3813622 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C3813622 (UMLS CUI [6,1])
C0022885 (UMLS CUI [6,2])
Localized primary osteoarthritis of knee Kellgren-Lawrence score | Knee Replacement Arthroplasty Planned
Item
patients diagnosed with primary osteoarthritis of the knee assessed locally with a disease grade 3 or 4 as determined by the kellgren & lawrence scale for whom a total knee replacement is planned
boolean
C2103692 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C0086511 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Health Status Acceptable Knee Replacement Arthroplasty
Item
general health status acceptable for total knee replacement surgery in the opinion of the investigator
boolean
C0018759 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0086511 (UMLS CUI [1,3])
Pharmaceutical Preparations Stable Consistent with Standard of Care | Analgesics | Antibiotic Prophylaxis
Item
stable medications consistent with standard of care (such as appropriate pain medication, antibiotics prophylaxis) are acceptable within 6 month prior enrollment
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C2936643 (UMLS CUI [1,4])
C0002771 (UMLS CUI [2])
C0282638 (UMLS CUI [3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Arthritis | Rheumatoid Arthritis | Arthritis, Psoriatic | Ankylosing spondylitis | Gout | Communicable Disease | Chronic infectious disease | Cartilage Disease Systemic
Item
presence of inflammatory arthropathy (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout), active acute or chronic infection, or systemic cartilage disorder
boolean
C0003864 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0003872 (UMLS CUI [3])
C0038013 (UMLS CUI [4])
C0018099 (UMLS CUI [5])
C0009450 (UMLS CUI [6])
C0151317 (UMLS CUI [7])
C0007302 (UMLS CUI [8,1])
C0205373 (UMLS CUI [8,2])
Cartilage repair Knee Same | Microfractures Knee Same | Autologous chondrocyte implantation Knee Same
Item
prior cartilage repair surgery, e.g. microfracture, autologous cartilage implantation (aci) or else, at the same knee
boolean
C1112785 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C1265651 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0445247 (UMLS CUI [2,3])
C1504240 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])
C0445247 (UMLS CUI [3,3])
Operative procedure on knee | Local Therapy Intra-articular Knee | Viscosupplementation
Item
any surgical therapy or local treatment i.a. into the knee (viscosupplementation) to the knee within 6 months prior to enrollment
boolean
C0187769 (UMLS CUI [1])
C1517925 (UMLS CUI [2,1])
C0442108 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
C2350507 (UMLS CUI [3])
Body mass index | Diabetic - poor control | Hyperthyroidism Uncontrolled
Item
bmi > 35; presence of uncontrolled diabetes or hyperthyroidism
boolean
C1305855 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
C0020550 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Effusion Large Knee Involved
Item
large effusion in the knee to be replaced, <1 cm fluid in the suprapatellar space at the midline
boolean
C0013687 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C1314939 (UMLS CUI [1,4])
Adrenal Cortex Hormones Drug Administration Route Any | Exception Topical Route of Drug Administration
Item
corticosteroid use by any route except topical within 3 months prior to enrollment
boolean
C0001617 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1522168 (UMLS CUI [2,2])
Malignant Neoplasms Organ system | Exception Basal cell carcinoma Localized Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Localized Untreated | Exception Carcinoma in situ of uterine cervix Untreated
Item
history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
boolean
C0006826 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0392752 (UMLS CUI [2,3])
C1522326 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C0392752 (UMLS CUI [4,3])
C0332155 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C0332155 (UMLS CUI [5,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential
Item
women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
boolean
C3831118 (UMLS CUI [1])
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