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])
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])