ID

35637

Beschrijving

Zimmer Trabecular Metal Total Ankle; ODM derived from: https://clinicaltrials.gov/show/NCT02038140

Link

https://clinicaltrials.gov/show/NCT02038140

Trefwoorden

  1. 13-03-19 13-03-19 -
  2. 13-03-19 13-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 maart 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Degenerative Arthritis NCT02038140

Eligibility Degenerative Arthritis NCT02038140

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient is > 18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
the patient is skeletally mature
Beschrijving

Skeleton Mature

Datatype

boolean

Alias
UMLS CUI [1,1]
C0816871
UMLS CUI [1,2]
C0205286
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.
Beschrijving

Qualification Total ankle replacement Primary | Qualification Revision of total replacement of ankle joint | Physical Examination | Medical History | Degenerative arthritis | Rheumatoid Arthritis | Arthritis Posttraumatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C1709790
UMLS CUI [1,2]
C0188664
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C1709790
UMLS CUI [2,2]
C0188642
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0262926
UMLS CUI [5]
C0029408
UMLS CUI [6]
C0003873
UMLS CUI [7,1]
C0003864
UMLS CUI [7,2]
C0231288
the patient is willing and able to provide written informed consent
Beschrijving

Informed Consent Willing | Informed Consent Able

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299581
patient is willing and able to cooperate in the required post-operative therapy
Beschrijving

Cooperation Therapy Postoperative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392337
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0032790
the patient is willing and able to complete scheduled follow-up evaluations questionnaires as described in the informed consent
Beschrijving

Follow-up Questionnaires Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0205197
the patient has participated in the informed consent process and has signed the institutional review board/european commission approved informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Beschrijving

Prisoner | Mental Incompetency | Study Protocol Comprehension Unable | Substance Use Disorders | Compliance behavior Lacking

Datatype

boolean

Alias
UMLS CUI [1]
C0033167
UMLS CUI [2]
C0086455
UMLS CUI [3,1]
C2348563
UMLS CUI [3,2]
C0162340
UMLS CUI [3,3]
C1299582
UMLS CUI [4]
C0038586
UMLS CUI [5,1]
C1321605
UMLS CUI [5,2]
C0332268
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.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0015385
UMLS CUI [1,4]
C1314939
UMLS CUI [2]
C0188661
UMLS CUI [3,1]
C0919588
UMLS CUI [3,2]
C0230449
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0042373
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C1517945
UMLS CUI [6,2]
C1995013
UMLS CUI [7]
C4062805
UMLS CUI [8,1]
C1444783
UMLS CUI [8,2]
C0205082
UMLS CUI [9]
C2177125
UMLS CUI [10,1]
C1275957
UMLS CUI [10,2]
C0039277
UMLS CUI [11,1]
C0374711
UMLS CUI [11,2]
C1272705
the patient has a local/systemic infection that may affect the prosthetic joint
Beschrijving

Local infection Affecting Joint Prosthesis | Sepsis Affecting Joint Prosthesis

Datatype

boolean

Alias
UMLS CUI [1,1]
C1400591
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0022414
UMLS CUI [2,1]
C0243026
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0022414
the patient has a previous history of infection in the affected joint
Beschrijving

Communicable Disease Joint affected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1314939
the patient is known to be pregnant
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
the patient has insufficient bone stock or bone quality to fix the components (i.e. osteoporosis, charcot's disease)
Beschrijving

Bone Mass Insufficient | Bone Quality Insufficient | Osteoporosis | Neurogenic arthropathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C1306372
UMLS CUI [1,3]
C0231180
UMLS CUI [2,1]
C0262950
UMLS CUI [2,2]
C0332306
UMLS CUI [2,3]
C0231180
UMLS CUI [3]
C0029456
UMLS CUI [4]
C0003892
the patient has a known sensitivity or allergic reaction to one or more of the implanted materials
Beschrijving

Hypersensitivity Implants Quantity | Allergic Reaction Implants Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021102
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0021102
UMLS CUI [2,3]
C1265611
the patient is unwilling or unable to give consent or to comply with the follow-up program
Beschrijving

Informed Consent Unwilling | Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582

Similar models

Eligibility Degenerative Arthritis NCT02038140

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