ID

15731

Descrição

Project JAY THA Registration Study; ODM derived from: https://clinicaltrials.gov/show/NCT02347384

Link

https://clinicaltrials.gov/show/NCT02347384

Palavras-chave

Versões (1)
  1. 10/06/2016 10/06/2016 -
Transferido a

10 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT02347384

Inglês

Eligibility Osteoarthritis NCT02347384

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects, aged between 50 and 75 years inclusive of chinese ethnicity.
Descrição

Age | Ethnicity Chinese

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0015031
UMLS CUI [2,2]
C0152035
subject presents with osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis of hip joint, developmental dysplasia of the hip, or femoral neck fracture requiring primary total hip replacement.
Descrição

Degenerative polyarthritis | Rheumatoid Arthritis | Arthritis Post Trauma | Avascular necrosis Hip Joint | Hip Dislocation, Congenital | Femoral Neck Fractures Requirement Total Hip Replacement Primary

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029408
UMLS CUI [2]
C0003873
UMLS CUI [3,1]
C0003864
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C3714660
UMLS CUI [4,1]
C3887513
UMLS CUI [4,2]
C0019558
UMLS CUI [5]
C0019555
UMLS CUI [6,1]
C0015806
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0040508
UMLS CUI [6,4]
C0205225
subject who is able to give voluntary, written informed consent to participate in the study and from whom consent has been obtained by signing and dating an ec-approved consent form.
Descrição

Informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
subject who is able to understand this clinical study, co-operates with the investigational procedures and is willing to return to the hospital for all the required post-operative follow-ups for up to 12 months.
Descrição

Comprehension Study Protocol | Compliance behavior | follow-up

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C1321605
UMLS CUI [3]
C1522577
life expectancy of subject is over 2 years.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 12 months).
Descrição

Disorder of hip region Bilateral | Patient need for hip implant Bilateral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1290862
UMLS CUI [1,2]
C0238767
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0841007
UMLS CUI [2,3]
C0238767
subject experienced prior joint replacement surgery on any major joint (hip, knee) in lower limb within the last 12 months.
Descrição

Arthroplasty, Replacement Previous | Joint Major | Hip Joint | Knee joint | Lower Extremity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0185317
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0022417
UMLS CUI [2,2]
C0205164
UMLS CUI [3]
C0019558
UMLS CUI [4]
C0022745
UMLS CUI [5]
C0023216
subject with developmental dysplasia of the hip of crowe grade 3 or 4.
Descrição

Hip Dislocation, Congenital

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019555
subject has known or suspected metal sensitivity.
Descrição

Hypersensitivity Metals

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0025552
subject is known to have insufficient bone stock resulting from conditions such as cancer, significant osteoporosis or metabolic bone disorders, which cannot provide adequate support and/or fixation to the prosthesis.
Descrição

Skeletal bone Insufficient | Malignant Neoplasms | Osteoporosis | Metabolic Bone Disorder | Prosthesis Fixation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C0231180
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0029456
UMLS CUI [4]
C0005944
UMLS CUI [5]
C3178966
subject is severely obese (bmi>35).
Descrição

Obesity Severe | Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0028754
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1305855
subject had an active infection or sepsis (treated or untreated).
Descrição

Communicable Diseases | Sepsis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0243026
subject has conditions that may compromise implant stability or postoperative recovery (i.e., paget's or charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency, hip abduction muscle strength less than grade iv or complete loss, or neuromuscular disease).
Descrição

medical condition compromises Implant Stable status | medical condition compromises Postoperative recovery | Paget's Disease | Amyotrophic Lateral Sclerosis | Vascular insufficiency | Muscular Atrophy | DIABETES MELLITUS NOS UNCONTROLLED | Renal Insufficiency Moderate | Renal Insufficiency Severe | Hip abduction Muscle Strength | Oxford grading scale for muscle strength | Neuromuscular Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0021102
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C1699700
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C4061108
UMLS CUI [3]
C1368019
UMLS CUI [4]
C0002736
UMLS CUI [5]
C0232352
UMLS CUI [6]
C0026846
UMLS CUI [7]
C0743131
UMLS CUI [8,1]
C1565489
UMLS CUI [8,2]
C0205081
UMLS CUI [9,1]
C1565489
UMLS CUI [9,2]
C0205082
UMLS CUI [10,1]
C2030964
UMLS CUI [10,2]
C0517349
UMLS CUI [11]
C0451362
UMLS CUI [12]
C0027868
subject has an emotional or neurological condition that would affect their ability or willingness to participate in the study (e.g. cognitive disorder, mental illness, mental retardation).
Descrição

Study Subject Participation Status Limited | Emotional disorder | nervous system disorder | Cognition Disorders | Mental disorders | Mental Retardation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0439801
UMLS CUI [2]
C0233459
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0009241
UMLS CUI [5]
C0004936
UMLS CUI [6]
C0025362
subject is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder. for examples, subject is on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or has acquired immunodeficiency syndrome (aids).
Descrição

Immunosuppressed | Autoimmune Diseases | Immunosuppression | Therapeutic immunosuppression | Steroid hormone | Cytotoxic agent | Antilymphocytic serum | Therapeutic radiology procedure | Acquired Immunodeficiency Syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085393
UMLS CUI [2]
C0004364
UMLS CUI [3]
C4048329
UMLS CUI [4]
C0021079
UMLS CUI [5]
C0301818
UMLS CUI [6]
C0304497
UMLS CUI [7]
C3826731
UMLS CUI [8]
C1522449
UMLS CUI [9]
C0001175
subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
Descrição

Compliance behavior Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
subject was enrolled in another investigational drug, biologic, or device study in the last 12 months.
Descrição

Study Subject Participation Status | Investigational New Drugs | Biological Factors | Investigational Medical Device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0005515
UMLS CUI [4]
C2346570
subject is a woman who is pregnant or lactating，or intends to become pregnant during the course of the study.
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
known alcohol and/or drug abuse
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Osteoarthritis NCT02347384

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Ethnicity Chinese
Item
male or female subjects, aged between 50 and 75 years inclusive of chinese ethnicity.
boolean
C0001779 (UMLS CUI [1])
C0015031 (UMLS CUI [2,1])
C0152035 (UMLS CUI [2,2])
Degenerative polyarthritis | Rheumatoid Arthritis | Arthritis Post Trauma | Avascular necrosis Hip Joint | Hip Dislocation, Congenital | Femoral Neck Fractures Requirement Total Hip Replacement Primary
Item
subject presents with osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis of hip joint, developmental dysplasia of the hip, or femoral neck fracture requiring primary total hip replacement.
boolean
C0029408 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0003864 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C3714660 (UMLS CUI [3,3])
C3887513 (UMLS CUI [4,1])
C0019558 (UMLS CUI [4,2])
C0019555 (UMLS CUI [5])
C0015806 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0040508 (UMLS CUI [6,3])
C0205225 (UMLS CUI [6,4])
Informed consent
Item
subject who is able to give voluntary, written informed consent to participate in the study and from whom consent has been obtained by signing and dating an ec-approved consent form.
boolean
C0021430 (UMLS CUI [1])
Comprehension Study Protocol | Compliance behavior | follow-up
Item
subject who is able to understand this clinical study, co-operates with the investigational procedures and is willing to return to the hospital for all the required post-operative follow-ups for up to 12 months.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2])
C1522577 (UMLS CUI [3])
Life Expectancy
Item
life expectancy of subject is over 2 years.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disorder of hip region Bilateral | Patient need for hip implant Bilateral
Item
bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 12 months).
boolean
C1290862 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0841007 (UMLS CUI [2,2])
C0238767 (UMLS CUI [2,3])
Arthroplasty, Replacement Previous | Joint Major | Hip Joint | Knee joint | Lower Extremity
Item
subject experienced prior joint replacement surgery on any major joint (hip, knee) in lower limb within the last 12 months.
boolean
C0185317 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0022417 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0019558 (UMLS CUI [3])
C0022745 (UMLS CUI [4])
C0023216 (UMLS CUI [5])
Hip Dislocation, Congenital
Item
subject with developmental dysplasia of the hip of crowe grade 3 or 4.
boolean
C0019555 (UMLS CUI [1])
Hypersensitivity Metals
Item
subject has known or suspected metal sensitivity.
boolean
C0020517 (UMLS CUI [1,1])
C0025552 (UMLS CUI [1,2])
Skeletal bone Insufficient | Malignant Neoplasms | Osteoporosis | Metabolic Bone Disorder | Prosthesis Fixation
Item
subject is known to have insufficient bone stock resulting from conditions such as cancer, significant osteoporosis or metabolic bone disorders, which cannot provide adequate support and/or fixation to the prosthesis.
boolean
C0262950 (UMLS CUI [1,1])
C0231180 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C0029456 (UMLS CUI [3])
C0005944 (UMLS CUI [4])
C3178966 (UMLS CUI [5])
Obesity Severe | Body mass index
Item
subject is severely obese (bmi>35).
boolean
C0028754 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1305855 (UMLS CUI [2])
Communicable Diseases | Sepsis
Item
subject had an active infection or sepsis (treated or untreated).
boolean
C0009450 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
medical condition compromises Implant Stable status | medical condition compromises Postoperative recovery | Paget's Disease | Amyotrophic Lateral Sclerosis | Vascular insufficiency | Muscular Atrophy | DIABETES MELLITUS NOS UNCONTROLLED | Renal Insufficiency Moderate | Renal Insufficiency Severe | Hip abduction Muscle Strength | Oxford grading scale for muscle strength | Neuromuscular Diseases
Item
subject has conditions that may compromise implant stability or postoperative recovery (i.e., paget's or charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency, hip abduction muscle strength less than grade iv or complete loss, or neuromuscular disease).
boolean
C1699700 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0021102 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C1699700 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C4061108 (UMLS CUI [2,3])
C1368019 (UMLS CUI [3])
C0002736 (UMLS CUI [4])
C0232352 (UMLS CUI [5])
C0026846 (UMLS CUI [6])
C0743131 (UMLS CUI [7])
C1565489 (UMLS CUI [8,1])
C0205081 (UMLS CUI [8,2])
C1565489 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C2030964 (UMLS CUI [10,1])
C0517349 (UMLS CUI [10,2])
C0451362 (UMLS CUI [11])
C0027868 (UMLS CUI [12])
Study Subject Participation Status Limited | Emotional disorder | nervous system disorder | Cognition Disorders | Mental disorders | Mental Retardation
Item
subject has an emotional or neurological condition that would affect their ability or willingness to participate in the study (e.g. cognitive disorder, mental illness, mental retardation).
boolean
C2348568 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0233459 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0009241 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C0025362 (UMLS CUI [6])
Immunosuppressed | Autoimmune Diseases | Immunosuppression | Therapeutic immunosuppression | Steroid hormone | Cytotoxic agent | Antilymphocytic serum | Therapeutic radiology procedure | Acquired Immunodeficiency Syndrome
Item
subject is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder. for examples, subject is on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or has acquired immunodeficiency syndrome (aids).
boolean
C0085393 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C4048329 (UMLS CUI [3])
C0021079 (UMLS CUI [4])
C0301818 (UMLS CUI [5])
C0304497 (UMLS CUI [6])
C3826731 (UMLS CUI [7])
C1522449 (UMLS CUI [8])
C0001175 (UMLS CUI [9])
Compliance behavior Limited
Item
subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs | Biological Factors | Investigational Medical Device
Item
subject was enrolled in another investigational drug, biologic, or device study in the last 12 months.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0005515 (UMLS CUI [3])
C2346570 (UMLS CUI [4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
subject is a woman who is pregnant or lactating，or intends to become pregnant during the course of the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Substance Use Disorders
Item
known alcohol and/or drug abuse
boolean
C0038586 (UMLS CUI [1])
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