ID

44750

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02255383

Stichworte

Versionen (1)
  1. 2021-11-10 2021-11-10 -
Rechteinhaber

Zimmer Biomet

Hochgeladen am

10 november 2021

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Eligibility Severe Knee Pain NCT02255383

Englisch

Eligibility Severe Knee Pain NCT02255383

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

patient 18-75 years of age

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

informed consent

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

insufficient bone stock on femoral or tibial surfaces

Datentyp

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
Beschreibung

skeletal immaturity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3825673
UMLS CUI [1,2]
C0332197
neuropathic arthropathy
Beschreibung

neuropathic arthropathy

Datentyp

boolean

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

osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb

Datentyp

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
Beschreibung

stable, painless arthrodesis in a satisfactory functional position

Datentyp

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
Beschreibung

severe instability secondary to the absence of collateral ligament integrity

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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.)
Beschreibung

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

Datentyp

boolean

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

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

Datentyp

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
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Ähnliche Modelle

Eligibility Severe Knee Pain NCT02255383

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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