ID

13777

Descripción

Gender Solutions Natural Knee Post-Market Study; ODM derived from: https://clinicaltrials.gov/show/NCT01463566

Link

https://clinicaltrials.gov/show/NCT01463566

Palabras clave

  1. 6/3/16 6/3/16 -
Subido en

6 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Osteoarthritis NCT01463566

Eligibility Osteoarthritis NCT01463566

Inclusion Criteria
Descripción

Inclusion Criteria

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

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patient qualifies for a total knee arthroplasty based on physical exam and medical history including at least one of the following: osteoarthritis, inflammatory arthritis, post-traumatic arthritis, rheumatoid arthritis, or valgus, varus, or flexion deformities;
Descripción

knee arthroplasty; osteoarthritis; Arthritis; Valgus deformity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086511
UMLS CUI [2]
C0409959
UMLS CUI [3]
C0003864
UMLS CUI [4]
C0042282
patient has undergone a study related informed consent process;
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
patient is willing and able to provide written consent;
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
patient is willing and able to cooperate in the required post-operative therapy;
Descripción

compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
patient is willing and able to complete scheduled follow-up evaluations.
Descripción

compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has previous history of infection in the affected joint and/or a local or systemic infection that could affect the prosthetic joint;
Descripción

medical history joint infection; Prosthetic joint infection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0157749
UMLS CUI [2]
C0410808
insufficient bone stock on femoral or tibial surfaces;
Descripción

Surface of femur

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0828554
skeletal immaturity
Descripción

Immature Bone

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1704398
neuropathic arthropathy
Descripción

neuropathic arthropathy

Tipo de datos

boolean

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

osteoporosis; neuromuscular disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029456
UMLS CUI [2]
C0027868
stable, painless arthrodesis in a satisfactory functional position;
Descripción

arthrodesis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003881
severe instability secondary to the absence of collateral ligament integrity;
Descripción

Joint Instability; collateral ligament

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022410
UMLS CUI [2]
C0206365
patient has rheumatoid arthritis and an ulcer of the skin or a history of recurrent breakdown of the skin because of their risk of postoperative infection is greater;
Descripción

rheumatoid arthritis; Skin Ulcer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0037299
patient has known sensitivity or allergy to one or more of the implanted materials;
Descripción

hypersensitivity Implants

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021102
patients pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)
Descripción

pregnancy; Mental Incompetency; prisoner

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0086455
UMLS CUI [3]
C0033167

Similar models

Eligibility Osteoarthritis NCT01463566

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
patient 18-75 years of age, inclusive;
boolean
C0001779 (UMLS CUI [1])
knee arthroplasty; osteoarthritis; Arthritis; Valgus deformity
Item
patient qualifies for a total knee arthroplasty based on physical exam and medical history including at least one of the following: osteoarthritis, inflammatory arthritis, post-traumatic arthritis, rheumatoid arthritis, or valgus, varus, or flexion deformities;
boolean
C0086511 (UMLS CUI [1])
C0409959 (UMLS CUI [2])
C0003864 (UMLS CUI [3])
C0042282 (UMLS CUI [4])
informed consent
Item
patient has undergone a study related informed consent process;
boolean
C0021430 (UMLS CUI [1])
informed consent
Item
patient is willing and able to provide written consent;
boolean
C0021430 (UMLS CUI [1])
compliance
Item
patient is willing and able to cooperate in the required post-operative therapy;
boolean
C1321605 (UMLS CUI [1])
compliance
Item
patient is willing and able to complete scheduled follow-up evaluations.
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
medical history joint infection; Prosthetic joint infection
Item
patient has previous history of infection in the affected joint and/or a local or systemic infection that could affect the prosthetic joint;
boolean
C0262926 (UMLS CUI [1,1])
C0157749 (UMLS CUI [1,2])
C0410808 (UMLS CUI [2])
Surface of femur
Item
insufficient bone stock on femoral or tibial surfaces;
boolean
C0828554 (UMLS CUI [1])
Immature Bone
Item
skeletal immaturity
boolean
C1704398 (UMLS CUI [1])
neuropathic arthropathy
Item
neuropathic arthropathy
boolean
C0003892 (UMLS CUI [1])
osteoporosis; neuromuscular disease
Item
osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;
boolean
C0029456 (UMLS CUI [1])
C0027868 (UMLS CUI [2])
arthrodesis
Item
stable, painless arthrodesis in a satisfactory functional position;
boolean
C0003881 (UMLS CUI [1])
Joint Instability; collateral ligament
Item
severe instability secondary to the absence of collateral ligament integrity;
boolean
C0022410 (UMLS CUI [1])
C0206365 (UMLS CUI [2])
rheumatoid arthritis; Skin Ulcer
Item
patient has rheumatoid arthritis and an ulcer of the skin or a history of recurrent breakdown of the skin because of their risk of postoperative infection is greater;
boolean
C0003873 (UMLS CUI [1])
C0037299 (UMLS CUI [2])
hypersensitivity Implants
Item
patient has known sensitivity or allergy to one or more of the implanted materials;
boolean
C0020517 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
pregnancy; Mental Incompetency; prisoner
Item
patients pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)
boolean
C0549206 (UMLS CUI [1])
C0086455 (UMLS CUI [2])
C0033167 (UMLS CUI [3])

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