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

  1. 06/03/2016 06/03/2016 -
Transferido a

6 de março de 2016

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Osteoarthritis NCT01463566

Eligibility Osteoarthritis NCT01463566

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient 18-75 years of age, inclusive;
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
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;
Descrição

knee arthroplasty; osteoarthritis; Arthritis; Valgus deformity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086511
UMLS CUI [2]
C0409959
UMLS CUI [3]
C0003864
UMLS CUI [4]
C0042282
patient has undergone a study related informed consent process;
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patient is willing and able to provide written consent;
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patient is willing and able to cooperate in the required post-operative therapy;
Descrição

compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
patient is willing and able to complete scheduled follow-up evaluations.
Descrição

compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has previous history of infection in the affected joint and/or a local or systemic infection that could affect the prosthetic joint;
Descrição

medical history joint infection; Prosthetic joint infection

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0157749
UMLS CUI [2]
C0410808
insufficient bone stock on femoral or tibial surfaces;
Descrição

Surface of femur

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0828554
skeletal immaturity
Descrição

Immature Bone

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1704398
neuropathic arthropathy
Descrição

neuropathic arthropathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003892
osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;
Descrição

osteoporosis; neuromuscular disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029456
UMLS CUI [2]
C0027868
stable, painless arthrodesis in a satisfactory functional position;
Descrição

arthrodesis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003881
severe instability secondary to the absence of collateral ligament integrity;
Descrição

Joint Instability; collateral ligament

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022410
UMLS CUI [2]
C0206365
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;
Descrição

rheumatoid arthritis; Skin Ulcer

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0037299
patient has known sensitivity or allergy to one or more of the implanted materials;
Descrição

hypersensitivity Implants

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021102
patients pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)
Descrição

pregnancy; Mental Incompetency; prisoner

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0086455
UMLS CUI [3]
C0033167

Similar models

Eligibility Osteoarthritis NCT01463566

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
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])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial