ID

31286

Description

Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study; ODM derived from: https://clinicaltrials.gov/show/NCT01010269

Link

https://clinicaltrials.gov/show/NCT01010269

Keywords

Versions (1)
  1. 8/8/18 8/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT01010269

English

Eligibility Osteoarthritis NCT01010269

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
painful and disabled knee joint resulting form osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
Description

Knee joint Painful Disabled | Etiology Osteoarthritis | Etiology Rheumatoid Arthritis | Etiology Traumatic arthritis | Involvement with Compartment Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0022745
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C1880351
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0029408
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0003873
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0152086
UMLS CUI [5,1]
C1314939
UMLS CUI [5,2]
C0447798
UMLS CUI [5,3]
C1265611
correction of varus, valgus, or posttraumatic deformity.
Description

Correction Genu varum | Correction Genu valgum | Correction Deformity Posttraumatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1947976
UMLS CUI [1,2]
C0544755
UMLS CUI [2,1]
C1947976
UMLS CUI [2,2]
C0576093
UMLS CUI [3,1]
C1947976
UMLS CUI [3,2]
C0302142
UMLS CUI [3,3]
C0231288
correction or revision of unsuccessful osteotomy, or arthrodesis.
Description

Correction Osteotomy Unsuccessful | Revision Osteotomy Unsuccessful | Correction Arthrodesis Unsuccessful | Revision Arthrodesis Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C1947976
UMLS CUI [1,2]
C0029468
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C0558347
UMLS CUI [2,2]
C0029468
UMLS CUI [2,3]
C1272705
UMLS CUI [3,1]
C1947976
UMLS CUI [3,2]
C0003881
UMLS CUI [3,3]
C1272705
UMLS CUI [4,1]
C0558347
UMLS CUI [4,2]
C0003881
UMLS CUI [4,3]
C1272705
need to obtain pain relief and improve function.
Description

Patient need for Pain relief | Patient need for Function Improve

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0451615
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0031843
UMLS CUI [2,3]
C0184511
ability and willingness of the patient to follow instructions, including control of weight and activity level.
Description

Instructions Adherence | Weight control behavior | Activity level

Data type

boolean

Alias
UMLS CUI [1,1]
C2051542
UMLS CUI [1,2]
C1510802
UMLS CUI [2]
C1321111
UMLS CUI [3]
C0683317
good nutritional state of the patient.
Description

Nutritional status Good

Data type

boolean

Alias
UMLS CUI [1,1]
C0392209
UMLS CUI [1,2]
C0205170
patient must have reached full skeletal maturity.
Description

Skeletal maturity Full

Data type

boolean

Alias
UMLS CUI [1,1]
C3825673
UMLS CUI [1,2]
C0443225
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
infection, sepsis, osteomyelitis, and failure of previous joint replacement.
Description

Communicable Disease | Sepsis | Osteomyelitis | Joint Replacement failed

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0243026
UMLS CUI [3]
C0029443
UMLS CUI [4,1]
C0185317
UMLS CUI [4,2]
C0231175
uncooperative patient or patients with neurologic disorders who are incapable of following directions.
Description

Patient uncooperative | Nervous system disorder | Follow directions incapable

Data type

boolean

Alias
UMLS CUI [1]
C0747308
UMLS CUI [2]
C0027765
UMLS CUI [3,1]
C1720622
UMLS CUI [3,2]
C1550518
osteoporosis
Description

Osteoporosis

Data type

boolean

Alias
UMLS CUI [1]
C0029456
metabolic disorders which may impair bone formation
Description

Metabolic Diseases Impairing Osteogenesis

Data type

boolean

Alias
UMLS CUI [1,1]
C0025517
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0029433
osteomalacia
Description

Osteomalacia

Data type

boolean

Alias
UMLS CUI [1]
C0029442
distant foci of infections which may spread to the implant site
Description

Communicable Disease Foci Distant

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0443203
rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Description

Joint destruction Rapid | Osteopenia Marked | Bone Resorption Roentgenogram

Data type

boolean

Alias
UMLS CUI [1,1]
C0541875
UMLS CUI [1,2]
C0456962
UMLS CUI [2,1]
C0029453
UMLS CUI [2,2]
C1706089
UMLS CUI [3,1]
C0005974
UMLS CUI [3,2]
C1306645
vascular insufficiency, muscular atrophy, neuromuscular disease
Description

Vascular insufficiency | Muscular Atrophy | Neuromuscular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0232352
UMLS CUI [2]
C0026846
UMLS CUI [3]
C0027868
incomplete or deficient soft tissue surrounding the knee
Description

Soft tissue of knee region Incomplete | Soft tissue of knee region Deficient

Data type

boolean

Alias
UMLS CUI [1,1]
C4544264
UMLS CUI [1,2]
C0205257
UMLS CUI [2,1]
C4544264
UMLS CUI [2,2]
C0011155
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Similar models

Eligibility Osteoarthritis NCT01010269

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Knee joint Painful Disabled | Etiology Osteoarthritis | Etiology Rheumatoid Arthritis | Etiology Traumatic arthritis | Involvement with Compartment Quantity
Item
painful and disabled knee joint resulting form osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
boolean
C0022745 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1880351 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0152086 (UMLS CUI [4,2])
C1314939 (UMLS CUI [5,1])
C0447798 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Correction Genu varum | Correction Genu valgum | Correction Deformity Posttraumatic
Item
correction of varus, valgus, or posttraumatic deformity.
boolean
C1947976 (UMLS CUI [1,1])
C0544755 (UMLS CUI [1,2])
C1947976 (UMLS CUI [2,1])
C0576093 (UMLS CUI [2,2])
C1947976 (UMLS CUI [3,1])
C0302142 (UMLS CUI [3,2])
C0231288 (UMLS CUI [3,3])
Correction Osteotomy Unsuccessful | Revision Osteotomy Unsuccessful | Correction Arthrodesis Unsuccessful | Revision Arthrodesis Unsuccessful
Item
correction or revision of unsuccessful osteotomy, or arthrodesis.
boolean
C1947976 (UMLS CUI [1,1])
C0029468 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0558347 (UMLS CUI [2,1])
C0029468 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C1947976 (UMLS CUI [3,1])
C0003881 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
C0558347 (UMLS CUI [4,1])
C0003881 (UMLS CUI [4,2])
C1272705 (UMLS CUI [4,3])
Patient need for Pain relief | Patient need for Function Improve
Item
need to obtain pain relief and improve function.
boolean
C0686904 (UMLS CUI [1,1])
C0451615 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0184511 (UMLS CUI [2,3])
Instructions Adherence | Weight control behavior | Activity level
Item
ability and willingness of the patient to follow instructions, including control of weight and activity level.
boolean
C2051542 (UMLS CUI [1,1])
C1510802 (UMLS CUI [1,2])
C1321111 (UMLS CUI [2])
C0683317 (UMLS CUI [3])
Nutritional status Good
Item
good nutritional state of the patient.
boolean
C0392209 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
Skeletal maturity Full
Item
patient must have reached full skeletal maturity.
boolean
C3825673 (UMLS CUI [1,1])
C0443225 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease | Sepsis | Osteomyelitis | Joint Replacement failed
Item
infection, sepsis, osteomyelitis, and failure of previous joint replacement.
boolean
C0009450 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
C0029443 (UMLS CUI [3])
C0185317 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
Patient uncooperative | Nervous system disorder | Follow directions incapable
Item
uncooperative patient or patients with neurologic disorders who are incapable of following directions.
boolean
C0747308 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C1720622 (UMLS CUI [3,1])
C1550518 (UMLS CUI [3,2])
Osteoporosis
Item
osteoporosis
boolean
C0029456 (UMLS CUI [1])
Metabolic Diseases Impairing Osteogenesis
Item
metabolic disorders which may impair bone formation
boolean
C0025517 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0029433 (UMLS CUI [1,3])
Osteomalacia
Item
osteomalacia
boolean
C0029442 (UMLS CUI [1])
Communicable Disease Foci Distant
Item
distant foci of infections which may spread to the implant site
boolean
C0009450 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0443203 (UMLS CUI [1,3])
Joint destruction Rapid | Osteopenia Marked | Bone Resorption Roentgenogram
Item
rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
boolean
C0541875 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
C0029453 (UMLS CUI [2,1])
C1706089 (UMLS CUI [2,2])
C0005974 (UMLS CUI [3,1])
C1306645 (UMLS CUI [3,2])
Vascular insufficiency | Muscular Atrophy | Neuromuscular Disease
Item
vascular insufficiency, muscular atrophy, neuromuscular disease
boolean
C0232352 (UMLS CUI [1])
C0026846 (UMLS CUI [2])
C0027868 (UMLS CUI [3])
Soft tissue of knee region Incomplete | Soft tissue of knee region Deficient
Item
incomplete or deficient soft tissue surrounding the knee
boolean
C4544264 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C4544264 (UMLS CUI [2,1])
C0011155 (UMLS CUI [2,2])
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