ID

22258

Beskrivning

A Study of Patients Treated With the Journey Deuce Bicompartmental Knee System; ODM derived from: https://clinicaltrials.gov/show/NCT01704326

Länk

https://clinicaltrials.gov/show/NCT01704326

Nyckelord

Versioner (1)
  1. 2017-05-27 2017-05-27 -
Uppladdad den

27 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT01704326

Engelsk

Eligibility Osteoarthritis NCT01704326

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement.
Beskrivning

Degenerative joint disease Medial compartment of knee | Degenerative joint disease Patellofemoral | Knee Replacement Unilateral Patient need for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0447799
UMLS CUI [2,1]
C0029408
UMLS CUI [2,2]
C0409325
UMLS CUI [3,1]
C0086511
UMLS CUI [3,2]
C0205092
UMLS CUI [3,3]
C0686904
patient is 30 to 75 years of age, inclusive.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patient is willing to consent to participate in the study by signing and dating an irb-approved consent form.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patient plans to be available for follow-up through five years postoperative.
Beskrivning

Clinical Study Follow-up Postoperative Duration | Patient Availability of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0032790
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders.
Beskrivning

Femur Bone Marrow Insufficient | Tibia Bone Marrow Insufficient | Malignant Neoplasms | Osteotomy of distal femur | Osteotomy of proximal tibia | Osteoporosis | Metabolic Bone Disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2698535
UMLS CUI [1,2]
C0231180
UMLS CUI [2,1]
C2698539
UMLS CUI [2,2]
C0231180
UMLS CUI [3]
C0006826
UMLS CUI [4]
C0407483
UMLS CUI [5]
C0407484
UMLS CUI [6]
C0029456
UMLS CUI [7]
C0005944
patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder (i.e. chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or patients with acquired immunodeficiency syndrome (aids).
Beskrivning

Immunocompromised Host | Autoimmune Diseases | Immunosuppression | Condition chronic | Response to antigens Ability inhibited | Therapeutic immunosuppression | Adrenal Cortex Hormones Large amount | Cytotoxic agent | Antilymphocytic serum | Therapeutic radiology procedure Dosage Large | Acquired Immunodeficiency Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0085393
UMLS CUI [2]
C0004364
UMLS CUI [3]
C4048329
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0205191
UMLS CUI [5,1]
C1314973
UMLS CUI [5,2]
C0085732
UMLS CUI [5,3]
C0311403
UMLS CUI [6]
C0021079
UMLS CUI [7,1]
C0001617
UMLS CUI [7,2]
C3869890
UMLS CUI [8]
C0304497
UMLS CUI [9]
C3826731
UMLS CUI [10,1]
C1522449
UMLS CUI [10,2]
C0178602
UMLS CUI [10,3]
C0549177
UMLS CUI [11]
C0001175
patient has inflammatory arthritis (e.g. rheumatoid arthritis)
Beskrivning

Arthritis | Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0003873
patient has bmi greater than or equal to 40.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
patient has had major knee surgery in the past i.e. hto, unicondylar knee replacement, failed fracture fixation.
Beskrivning

Operative procedure on knee Major | Osteotomy of proximal tibia | Arthroplasty, Replacement, Partial Knee | Fracture Fixation failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0187769
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0407484
UMLS CUI [3]
C0864243
UMLS CUI [4,1]
C0016641
UMLS CUI [4,2]
C0231175
patient has an active infection, local or systemic.
Beskrivning

local; infection | Sepsis

Datatyp

boolean

Alias
UMLS CUI [1]
C1400591
UMLS CUI [2]
C0243026
patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and followup (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as parkinson, multiple sclerosis, etc.).
Beskrivning

Physical Condition compromises Protocol Compliance | Emotional condition compromises Protocol Compliance | Nervous system disorder compromises Protocol Compliance | Substance Use Disorders | Mental disorders Serious | Nervous system disorder General | Parkinson Disease | Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3714565
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3843038
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0525058
UMLS CUI [4]
C0038586
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0205404
UMLS CUI [6,1]
C0027765
UMLS CUI [6,2]
C0205246
UMLS CUI [7]
C0030567
UMLS CUI [8]
C0026769
patient has acl deficiency in the study knee.
Beskrivning

Deficiency of anterior cruciate ligament

Datatyp

boolean

Alias
UMLS CUI [1]
C0409310
patient has hip arthritis and/or replacement.
Beskrivning

Coxitis | Hip Replacement

Datatyp

boolean

Alias
UMLS CUI [1]
C0263776
UMLS CUI [2]
C0392806
patient has lateral compartment disease.
Beskrivning

Compartment Lateral Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0447798
UMLS CUI [1,2]
C0205093
UMLS CUI [1,3]
C0012634
patient is pregnant or plans to become pregnant during the course of the study.
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
patient has a known sensitivity to materials in the device.
Beskrivning

Hypersensitivity Medical Device Materials

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0025080
UMLS CUI [1,3]
C0520510
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Similar models

Eligibility Osteoarthritis NCT01704326

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Degenerative joint disease Medial compartment of knee | Degenerative joint disease Patellofemoral | Knee Replacement Unilateral Patient need for
Item
patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement.
boolean
C0029408 (UMLS CUI [1,1])
C0447799 (UMLS CUI [1,2])
C0029408 (UMLS CUI [2,1])
C0409325 (UMLS CUI [2,2])
C0086511 (UMLS CUI [3,1])
C0205092 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
Age
Item
patient is 30 to 75 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
patient is willing to consent to participate in the study by signing and dating an irb-approved consent form.
boolean
C0021430 (UMLS CUI [1])
Clinical Study Follow-up Postoperative Duration | Patient Availability of
Item
patient plans to be available for follow-up through five years postoperative.
boolean
C3274571 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Femur Bone Marrow Insufficient | Tibia Bone Marrow Insufficient | Malignant Neoplasms | Osteotomy of distal femur | Osteotomy of proximal tibia | Osteoporosis | Metabolic Bone Disorder
Item
patient is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders.
boolean
C2698535 (UMLS CUI [1,1])
C0231180 (UMLS CUI [1,2])
C2698539 (UMLS CUI [2,1])
C0231180 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3])
C0407483 (UMLS CUI [4])
C0407484 (UMLS CUI [5])
C0029456 (UMLS CUI [6])
C0005944 (UMLS CUI [7])
Immunocompromised Host | Autoimmune Diseases | Immunosuppression | Condition chronic | Response to antigens Ability inhibited | Therapeutic immunosuppression | Adrenal Cortex Hormones Large amount | Cytotoxic agent | Antilymphocytic serum | Therapeutic radiology procedure Dosage Large | Acquired Immunodeficiency Syndrome
Item
patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder (i.e. chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or patients with acquired immunodeficiency syndrome (aids).
boolean
C0085393 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C4048329 (UMLS CUI [3])
C0348080 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C1314973 (UMLS CUI [5,1])
C0085732 (UMLS CUI [5,2])
C0311403 (UMLS CUI [5,3])
C0021079 (UMLS CUI [6])
C0001617 (UMLS CUI [7,1])
C3869890 (UMLS CUI [7,2])
C0304497 (UMLS CUI [8])
C3826731 (UMLS CUI [9])
C1522449 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0549177 (UMLS CUI [10,3])
C0001175 (UMLS CUI [11])
Arthritis | Rheumatoid Arthritis
Item
patient has inflammatory arthritis (e.g. rheumatoid arthritis)
boolean
C0003864 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
Body mass index
Item
patient has bmi greater than or equal to 40.
boolean
C1305855 (UMLS CUI [1])
Operative procedure on knee Major | Osteotomy of proximal tibia | Arthroplasty, Replacement, Partial Knee | Fracture Fixation failed
Item
patient has had major knee surgery in the past i.e. hto, unicondylar knee replacement, failed fracture fixation.
boolean
C0187769 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0407484 (UMLS CUI [2])
C0864243 (UMLS CUI [3])
C0016641 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
local; infection | Sepsis
Item
patient has an active infection, local or systemic.
boolean
C1400591 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
Physical Condition compromises Protocol Compliance | Emotional condition compromises Protocol Compliance | Nervous system disorder compromises Protocol Compliance | Substance Use Disorders | Mental disorders Serious | Nervous system disorder General | Parkinson Disease | Multiple Sclerosis
Item
patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and followup (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as parkinson, multiple sclerosis, etc.).
boolean
C3714565 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3843038 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0038586 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0027765 (UMLS CUI [6,1])
C0205246 (UMLS CUI [6,2])
C0030567 (UMLS CUI [7])
C0026769 (UMLS CUI [8])
Deficiency of anterior cruciate ligament
Item
patient has acl deficiency in the study knee.
boolean
C0409310 (UMLS CUI [1])
Coxitis | Hip Replacement
Item
patient has hip arthritis and/or replacement.
boolean
C0263776 (UMLS CUI [1])
C0392806 (UMLS CUI [2])
Compartment Lateral Disease
Item
patient has lateral compartment disease.
boolean
C0447798 (UMLS CUI [1,1])
C0205093 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned
Item
patient is pregnant or plans to become pregnant during the course of the study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Hypersensitivity Medical Device Materials
Item
patient has a known sensitivity to materials in the device.
boolean
C0020517 (UMLS CUI [1,1])
C0025080 (UMLS CUI [1,2])
C0520510 (UMLS CUI [1,3])
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