ID

44750

Descrição

Persona Total Knee Arthroplasty Outcomes Study; ODM derived from: https://clinicaltrials.gov/show/NCT02255383

Link

https://clinicaltrials.gov/show/NCT02255383

Palavras-chave

Versões (1)
  1. 10/11/2021 10/11/2021 -
Titular dos direitos

Zimmer Biomet

Transferido a

10 de novembro de 2021

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 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.

Voltar para os comentários do modelo
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 Severe Knee Pain NCT02255383

Inglês

Eligibility Severe Knee Pain NCT02255383

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

patient 18-75 years of age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
Descrição

patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0031809
UMLS CUI [1,4]
C0231749
UMLS CUI [1,5]
C0205082
UMLS CUI [1,6]
C0231170
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0409959
UMLS CUI [2,3]
C0152086
UMLS CUI [2,4]
C0162323
UMLS CUI [3,1]
C0009326
UMLS CUI [3,2]
C0027543
UMLS CUI [3,3]
C0582800
UMLS CUI [4,1]
C0022745
UMLS CUI [4,2]
C0302142
UMLS CUI [4,3]
C0231288
UMLS CUI [5,1]
C0302142
UMLS CUI [5,2]
C0432593
UMLS CUI [5,3]
C0042282
UMLS CUI [5,4]
C0231452
UMLS CUI [5,5]
C0543467
UMLS CUI [5,6]
C0205156
UMLS CUI [5,7]
C0231175
UMLS CUI [5,8]
C0332197
UMLS CUI [5,9]
C1705847
UMLS CUI [5,10]
C0086511
UMLS CUI [5,11]
C0441989
patient has participated in 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 informed consent by signing and dating the irb or ec approved informed consent form
Descrição

patient is willing and able to provide written informed consent by signing and dating the irb or ec approved informed consent form

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0600109
UMLS CUI [1,3]
C0085732
UMLS CUI [1,4]
C1519316
UMLS CUI [1,5]
C1115437
UMLS CUI [1,6]
C0086911
patient is willing and able to complete scheduled study procedures and follow-up evaluations
Descrição

patient is willing and able to complete scheduled study procedures and follow-up evaluations

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C1522577
UMLS CUI [1,4]
C0600109
UMLS CUI [1,5]
C0085732
independent of study participation, patient is a candidate for commercially available persona fixed bearing knee components implanted in accordance with product labeling
Descrição

independent of study participation, patient is a candidate for commercially available persona fixed bearing knee components implanted in accordance with product labeling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0021102
UMLS CUI [1,5]
C0680536
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is currently participating in any other surgical intervention studies or pain management studies
Descrição

patient is currently participating in any other surgical intervention studies or pain management studies

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0521116
UMLS CUI [2,3]
C0002766
UMLS CUI [2,4]
C0008976
previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
Descrição

previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0410808
UMLS CUI [2,1]
C3714514
UMLS CUI [2,2]
C0205276
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0022414
UMLS CUI [3,1]
C3714514
UMLS CUI [3,2]
C0442893
UMLS CUI [3,3]
C0392760
UMLS CUI [3,4]
C0022414
insufficient bone stock on femoral or tibial surfaces
Descrição

insufficient bone stock on femoral or tibial surfaces

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C0828554
UMLS CUI [1,3]
C0231180
UMLS CUI [2,1]
C0262950
UMLS CUI [2,2]
C0040184
UMLS CUI [2,3]
C0205148
UMLS CUI [2,4]
C0231180
skeletal immaturity
Descrição

skeletal immaturity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3825673
UMLS CUI [1,2]
C0332197
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 or any loss of musculature or neuromuscular disease that compromises the affected limb

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029456
UMLS CUI [2]
C0026846
UMLS CUI [3,1]
C0027868
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0449685
stable, painless arthrodesis in a satisfactory functional position
Descrição

stable, painless arthrodesis in a satisfactory functional position

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003881
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0234225
UMLS CUI [1,4]
C0733755
UMLS CUI [1,5]
C0598463
UMLS CUI [1,6]
C0242428
severe instability secondary to the absence of collateral ligament integrity
Descrição

severe instability secondary to the absence of collateral ligament integrity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022410
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0206365
UMLS CUI [1,5]
C1947912
UMLS CUI [1,6]
C0332197
rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
Descrição

rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0037299
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0150077
UMLS CUI [2,3]
C2945760
UMLS CUI [2,4]
C0262926
patient has a known or suspected sensitivity or allergy to one or more of the implant materials
Descrição

patient has a known or suspected sensitivity or allergy to one or more of the implant materials

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0440216
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0020517
UMLS CUI [2,1]
C0440216
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0020517
patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Descrição

patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0949366
patient has previously received partial or total knee arthroplasty for the ipsilateral knee
Descrição

patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0441989
UMLS CUI [2,1]
C0864243
UMLS CUI [2,2]
C0441989
Voltar ao início da página

Similar models

Eligibility Severe Knee Pain NCT02255383

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
patient 18-75 years of age
Item
patient 18-75 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
Item
patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
boolean
C0086511 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0231749 (UMLS CUI [1,4])
C0205082 (UMLS CUI [1,5])
C0231170 (UMLS CUI [1,6])
C0003873 (UMLS CUI [2,1])
C0409959 (UMLS CUI [2,2])
C0152086 (UMLS CUI [2,3])
C0162323 (UMLS CUI [2,4])
C0009326 (UMLS CUI [3,1])
C0027543 (UMLS CUI [3,2])
C0582800 (UMLS CUI [3,3])
C0022745 (UMLS CUI [4,1])
C0302142 (UMLS CUI [4,2])
C0231288 (UMLS CUI [4,3])
C0302142 (UMLS CUI [5,1])
C0432593 (UMLS CUI [5,2])
C0042282 (UMLS CUI [5,3])
C0231452 (UMLS CUI [5,4])
C0543467 (UMLS CUI [5,5])
C0205156 (UMLS CUI [5,6])
C0231175 (UMLS CUI [5,7])
C0332197 (UMLS CUI [5,8])
C1705847 (UMLS CUI [5,9])
C0086511 (UMLS CUI [5,10])
C0441989 (UMLS CUI [5,11])
informed consent
Item
patient has participated in a study-related informed consent process
boolean
C0021430 (UMLS CUI [1])
patient is willing and able to provide written informed consent by signing and dating the irb or ec approved informed consent form
Item
patient is willing and able to provide written informed consent by signing and dating the irb or ec approved informed consent form
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C1519316 (UMLS CUI [1,4])
C1115437 (UMLS CUI [1,5])
C0086911 (UMLS CUI [1,6])
patient is willing and able to complete scheduled study procedures and follow-up evaluations
Item
patient is willing and able to complete scheduled study procedures and follow-up evaluations
boolean
C2348563 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,4])
C0085732 (UMLS CUI [1,5])
independent of study participation, patient is a candidate for commercially available persona fixed bearing knee components implanted in accordance with product labeling
Item
independent of study participation, patient is a candidate for commercially available persona fixed bearing knee components implanted in accordance with product labeling
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0021102 (UMLS CUI [1,4])
C0680536 (UMLS CUI [1,5])
Item Group
C0680251 (UMLS CUI)
patient is currently participating in any other surgical intervention studies or pain management studies
Item
patient is currently participating in any other surgical intervention studies or pain management studies
boolean
C2348568 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0002766 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
Item
previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
boolean
C0262926 (UMLS CUI [1,1])
C0410808 (UMLS CUI [1,2])
C3714514 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0022414 (UMLS CUI [2,4])
C3714514 (UMLS CUI [3,1])
C0442893 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C0022414 (UMLS CUI [3,4])
insufficient bone stock on femoral or tibial surfaces
Item
insufficient bone stock on femoral or tibial surfaces
boolean
C0262950 (UMLS CUI [1,1])
C0828554 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C0262950 (UMLS CUI [2,1])
C0040184 (UMLS CUI [2,2])
C0205148 (UMLS CUI [2,3])
C0231180 (UMLS CUI [2,4])
skeletal immaturity
Item
skeletal immaturity
boolean
C3825673 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
neuropathic arthropathy
Item
neuropathic arthropathy
boolean
C0003892 (UMLS CUI [1])
osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
Item
osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
boolean
C0029456 (UMLS CUI [1])
C0026846 (UMLS CUI [2])
C0027868 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0449685 (UMLS CUI [3,3])
stable, painless arthrodesis in a satisfactory functional position
Item
stable, painless arthrodesis in a satisfactory functional position
boolean
C0003881 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0234225 (UMLS CUI [1,3])
C0733755 (UMLS CUI [1,4])
C0598463 (UMLS CUI [1,5])
C0242428 (UMLS CUI [1,6])
severe instability secondary to the absence of collateral ligament integrity
Item
severe instability secondary to the absence of collateral ligament integrity
boolean
C0022410 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0206365 (UMLS CUI [1,4])
C1947912 (UMLS CUI [1,5])
C0332197 (UMLS CUI [1,6])
rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
Item
rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
boolean
C0003873 (UMLS CUI [1,1])
C0037299 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0150077 (UMLS CUI [2,2])
C2945760 (UMLS CUI [2,3])
C0262926 (UMLS CUI [2,4])
patient has a known or suspected sensitivity or allergy to one or more of the implant materials
Item
patient has a known or suspected sensitivity or allergy to one or more of the implant materials
boolean
C0440216 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0440216 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Item
patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
boolean
C0032961 (UMLS CUI [1])
C0949366 (UMLS CUI [2])
patient has previously received partial or total knee arthroplasty for the ipsilateral knee
Item
patient has previously received partial or total knee arthroplasty for the ipsilateral knee
boolean
C0086511 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0864243 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])
Voltar ao início da página 

Contacto

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

Campos marcados com * são obrigatórios.

Ajuda

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