Eligibility Degenerative Arthritis NCT02038140

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
the patient is > 18 years of age
boolean
C0001779 (UMLS CUI [1])
Skeleton Mature
Item
the patient is skeletally mature
boolean
C0816871 (UMLS CUI [1,1])
C0205286 (UMLS CUI [1,2])
Qualification Total ankle replacement Primary | Qualification Revision of total replacement of ankle joint | Physical Examination | Medical History | Degenerative arthritis | Rheumatoid Arthritis | Arthritis Posttraumatic
Item
the patient qualifies for primary or revision total ankle replacement based on physical exam and medical history including the following: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis.
boolean
C1709790 (UMLS CUI [1,1])
C0188664 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1709790 (UMLS CUI [2,1])
C0188642 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C0029408 (UMLS CUI [5])
C0003873 (UMLS CUI [6])
C0003864 (UMLS CUI [7,1])
C0231288 (UMLS CUI [7,2])
Informed Consent Willing | Informed Consent Able
Item
the patient is willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299581 (UMLS CUI [2,2])
Cooperation Therapy Postoperative
Item
patient is willing and able to cooperate in the required post-operative therapy
boolean
C0392337 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
Follow-up Questionnaires Completion
Item
the patient is willing and able to complete scheduled follow-up evaluations questionnaires as described in the informed consent
boolean
C3274571 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Informed Consent
Item
the patient has participated in the informed consent process and has signed the institutional review board/european commission approved informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prisoner | Mental Incompetency | Study Protocol Comprehension Unable | Substance Use Disorders | Compliance behavior Lacking
Item
the patient is: a prisoner, mentally incompetent or unable to understand what participation in the study entails, a known alcohol or drug abuser, anticipated to be non-compliant.
boolean
C0033167 (UMLS CUI [1])
C0086455 (UMLS CUI [2])
C2348563 (UMLS CUI [3,1])
C0162340 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0038586 (UMLS CUI [4])
C1321605 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
Condition compromises Limb affected | Arthrodesis of ankle | Exeresis Malleolar | Nervous system disorder Severe | Vascular Disease Severe | Loss Musculature | Neuromuscular impairment | Instability Severe | Misalignment of tibia | Misalignment Talus | Surgical repair Unsuccessful
Item
the patient has one of the following compromising the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological or vascular disease, loss of musculature or neuromuscular compromise, severe instability, maltracking or misalignment of the tibia and talus uncorrectable by surgery.
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,3])
C1314939 (UMLS CUI [1,4])
C0188661 (UMLS CUI [2])
C0919588 (UMLS CUI [3,1])
C0230449 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0042373 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C1517945 (UMLS CUI [6,1])
C1995013 (UMLS CUI [6,2])
C4062805 (UMLS CUI [7])
C1444783 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C2177125 (UMLS CUI [9])
C1275957 (UMLS CUI [10,1])
C0039277 (UMLS CUI [10,2])
C0374711 (UMLS CUI [11,1])
C1272705 (UMLS CUI [11,2])
Local infection Affecting Joint Prosthesis | Sepsis Affecting Joint Prosthesis
Item
the patient has a local/systemic infection that may affect the prosthetic joint
boolean
C1400591 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0022414 (UMLS CUI [1,3])
C0243026 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0022414 (UMLS CUI [2,3])
Communicable Disease Joint affected
Item
the patient has a previous history of infection in the affected joint
boolean
C0009450 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Pregnancy
Item
the patient is known to be pregnant
boolean
C0032961 (UMLS CUI [1])
Bone Mass Insufficient | Bone Quality Insufficient | Osteoporosis | Neurogenic arthropathy
Item
the patient has insufficient bone stock or bone quality to fix the components (i.e. osteoporosis, charcot's disease)
boolean
C0262950 (UMLS CUI [1,1])
C1306372 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C0262950 (UMLS CUI [2,1])
C0332306 (UMLS CUI [2,2])
C0231180 (UMLS CUI [2,3])
C0029456 (UMLS CUI [3])
C0003892 (UMLS CUI [4])
Hypersensitivity Implants Quantity | Allergic Reaction Implants Quantity
Item
the patient has a known sensitivity or allergic reaction to one or more of the implanted materials
boolean
C0020517 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0021102 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Informed Consent Unwilling | Informed Consent Unable
Item
the patient is unwilling or unable to give consent or to comply with the follow-up program
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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