Informações:
Falhas:
ID
13777
Descrição
Gender Solutions Natural Knee Post-Market Study; ODM derived from: https://clinicaltrials.gov/show/NCT01463566
Link
https://clinicaltrials.gov/show/NCT01463566
Palavras-chave
Versões (1)
- 06/03/2016 06/03/2016 -
Transferido a
6 de março de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT01463566
Eligibility Osteoarthritis NCT01463566
- StudyEvent: Eligibility
Similar models
Eligibility Osteoarthritis NCT01463566
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
age
Item
patient 18-75 years of age, inclusive;
boolean
C0001779 (UMLS CUI [1])
knee arthroplasty; osteoarthritis; Arthritis; Valgus deformity
Item
patient qualifies for a total knee arthroplasty based on physical exam and medical history including at least one of the following: osteoarthritis, inflammatory arthritis, post-traumatic arthritis, rheumatoid arthritis, or valgus, varus, or flexion deformities;
boolean
C0086511 (UMLS CUI [1])
C0409959 (UMLS CUI [2])
C0003864 (UMLS CUI [3])
C0042282 (UMLS CUI [4])
C0409959 (UMLS CUI [2])
C0003864 (UMLS CUI [3])
C0042282 (UMLS CUI [4])
informed consent
Item
patient has undergone a study related informed consent process;
boolean
C0021430 (UMLS CUI [1])
informed consent
Item
patient is willing and able to provide written consent;
boolean
C0021430 (UMLS CUI [1])
compliance
Item
patient is willing and able to cooperate in the required post-operative therapy;
boolean
C1321605 (UMLS CUI [1])
compliance
Item
patient is willing and able to complete scheduled follow-up evaluations.
boolean
C1321605 (UMLS CUI [1])
medical history joint infection; Prosthetic joint infection
Item
patient has previous history of infection in the affected joint and/or a local or systemic infection that could affect the prosthetic joint;
boolean
C0262926 (UMLS CUI [1,1])
C0157749 (UMLS CUI [1,2])
C0410808 (UMLS CUI [2])
C0157749 (UMLS CUI [1,2])
C0410808 (UMLS CUI [2])
Surface of femur
Item
insufficient bone stock on femoral or tibial surfaces;
boolean
C0828554 (UMLS CUI [1])
Immature Bone
Item
skeletal immaturity
boolean
C1704398 (UMLS CUI [1])
neuropathic arthropathy
Item
neuropathic arthropathy
boolean
C0003892 (UMLS CUI [1])
osteoporosis; neuromuscular disease
Item
osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;
boolean
C0029456 (UMLS CUI [1])
C0027868 (UMLS CUI [2])
C0027868 (UMLS CUI [2])
arthrodesis
Item
stable, painless arthrodesis in a satisfactory functional position;
boolean
C0003881 (UMLS CUI [1])
Joint Instability; collateral ligament
Item
severe instability secondary to the absence of collateral ligament integrity;
boolean
C0022410 (UMLS CUI [1])
C0206365 (UMLS CUI [2])
C0206365 (UMLS CUI [2])
rheumatoid arthritis; Skin Ulcer
Item
patient has rheumatoid arthritis and an ulcer of the skin or a history of recurrent breakdown of the skin because of their risk of postoperative infection is greater;
boolean
C0003873 (UMLS CUI [1])
C0037299 (UMLS CUI [2])
C0037299 (UMLS CUI [2])
hypersensitivity Implants
Item
patient has known sensitivity or allergy to one or more of the implanted materials;
boolean
C0020517 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C0021102 (UMLS CUI [1,2])
pregnancy; Mental Incompetency; prisoner
Item
patients pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)
boolean
C0549206 (UMLS CUI [1])
C0086455 (UMLS CUI [2])
C0033167 (UMLS CUI [3])
C0086455 (UMLS CUI [2])
C0033167 (UMLS CUI [3])