ID

30136

Beschreibung

Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty; ODM derived from: https://clinicaltrials.gov/show/NCT00983762

Link

https://clinicaltrials.gov/show/NCT00983762

Stichworte

Versionen (1)
  1. 14.05.18 14.05.18 -
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See clinicaltrials.gov

Hochgeladen am

14. Mai 2018

DOI

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Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT00983762

Englisch

Eligibility Knee Osteoarthritis NCT00983762

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
tka subjects:
Beschreibung

Total Knee Replacement Study Subject

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C0681850
1. patients requiring primary knee arthroplasty;
Beschreibung

Patient need for Knee Arthroplasty Primary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0086511
UMLS CUI [1,3]
C0205225
2. knee osteoarthritis;
Beschreibung

Osteoarthritis, Knee

Datentyp

boolean

Alias
UMLS CUI [1]
C0409959
3. subject has sufficient quantity or quality of bone support;
Beschreibung

Bone Support Quantity Sufficient | Bone Support Quality Sufficient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C1521721
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0205410
UMLS CUI [2,1]
C0262950
UMLS CUI [2,2]
C1521721
UMLS CUI [2,3]
C0332306
UMLS CUI [2,4]
C0205410
4. subject has no previous or active infection in the affected joint or systemic infection;
Beschreibung

Absence Communicable Disease Joint Affected | Sepsis Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0009450
UMLS CUI [1,3]
C0022417
UMLS CUI [1,4]
C0392760
UMLS CUI [2,1]
C0243026
UMLS CUI [2,2]
C0332197
5. subject judged to be available for follow-up through at least 1 year postoperative;
Beschreibung

Study Subject Available Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
6. all subjects in arthroplasty groups will be between 50-70 years of age
Beschreibung

Arthroplasty Groups Age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003893
UMLS CUI [1,2]
C0441833
UMLS CUI [1,3]
C0001779
healthy subjects:
Beschreibung

Healthy Volunteers

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
1. healthy subjects will have no complaints of knee pain or history of knee surgery or known arthritic knee changes.
Beschreibung

Knee pain Absent | Operative procedure on knee Absent | Knee Arthritic change Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0187769
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0022742
UMLS CUI [3,2]
C0741221
UMLS CUI [3,3]
C0332197
2. all subjects will have no history of prior lower extremity arthroplasty surgeries or systemic disease which could confound outcome measures.
Beschreibung

Arthroplasty Lower Extremity Absent | Systemic disease Absent | Interference Research results Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003893
UMLS CUI [1,2]
C0023216
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C0683954
UMLS CUI [3,3]
C0332197
3. all healthy persons will be 40-70 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues;
Beschreibung

Bone Support Quantity Insufficient | Bone Support Quality Insufficient | Malignant Neoplasms | Osteotomy Femoral | Osteoporosis | Metabolic Diseases Tissue Calcified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C1521721
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0231180
UMLS CUI [2,1]
C0262950
UMLS CUI [2,2]
C1521721
UMLS CUI [2,3]
C0332306
UMLS CUI [2,4]
C0231180
UMLS CUI [3]
C0006826
UMLS CUI [4,1]
C0029468
UMLS CUI [4,2]
C0015811
UMLS CUI [5]
C0029456
UMLS CUI [6,1]
C0025517
UMLS CUI [6,2]
C0040300
UMLS CUI [6,3]
C0175895
2. unable to return for follow up x-rays and clinical evaluation;
Beschreibung

Patient unavailable Follow-up X-ray | Patient unavailable Follow-up Clinical Evaluation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C1301818
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C4084924
3. unable to comprehending study protocol for any reason;
Beschreibung

Comprehension Study Protocol Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C1299582
4. systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery;
Beschreibung

Inflammatory joint disease Systemic | Rheumatoid Arthritis | Communicable Disease | Patient need for Revision Operative procedure on knee

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683381
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0009450
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C1527075
UMLS CUI [4,3]
C0187769
5. subject has an immunological disorder: immunosuppressive treatment characterized by markedly inhibited ability to respond to antigenic stimuli. examples of such conditions include subjects who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), subjects receiving therapy to prevent homograft rejection, subjects who have a documented history of acquired immunodeficiency syndrome (aids), or auto-immune diseases;
Beschreibung

Immune System Disease | Therapeutic immunosuppression | Disease Response Limited Antigen Stimulus | Adrenal Cortex Hormones Large amount | Cytotoxic agent | Antilymphocytic serum | Therapeutic radiology procedure Dose Large | Therapeutic procedure Preventing Homograft reaction | Acquired Immunodeficiency Syndrome | Autoimmune Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0021053
UMLS CUI [2]
C0021079
UMLS CUI [3,1]
C1704632
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0003320
UMLS CUI [3,4]
C0234402
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C3869890
UMLS CUI [5]
C0304497
UMLS CUI [6]
C3826731
UMLS CUI [7,1]
C1522449
UMLS CUI [7,2]
C0178602
UMLS CUI [7,3]
C0549177
UMLS CUI [8,1]
C0087111
UMLS CUI [8,2]
C1292733
UMLS CUI [8,3]
C1268810
UMLS CUI [9]
C0001175
UMLS CUI [10]
C0004364
6. subject has a neurologic condition that would influence the results of biomechanical analysis of whole body movement.
Beschreibung

Nervous system problem Influence Biomechanical assessment Body Movement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221571
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0846602
UMLS CUI [1,4]
C0026649
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Ähnliche Modelle

Eligibility Knee Osteoarthritis NCT00983762

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Total Knee Replacement Study Subject
Item
tka subjects:
boolean
C0086511 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Patient need for Knee Arthroplasty Primary
Item
1. patients requiring primary knee arthroplasty;
boolean
C0686904 (UMLS CUI [1,1])
C0086511 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Osteoarthritis, Knee
Item
2. knee osteoarthritis;
boolean
C0409959 (UMLS CUI [1])
Bone Support Quantity Sufficient | Bone Support Quality Sufficient
Item
3. subject has sufficient quantity or quality of bone support;
boolean
C0262950 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0205410 (UMLS CUI [1,4])
C0262950 (UMLS CUI [2,1])
C1521721 (UMLS CUI [2,2])
C0332306 (UMLS CUI [2,3])
C0205410 (UMLS CUI [2,4])
Absence Communicable Disease Joint Affected | Sepsis Absent
Item
4. subject has no previous or active infection in the affected joint or systemic infection;
boolean
C0332197 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0243026 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Study Subject Available Follow-up
Item
5. subject judged to be available for follow-up through at least 1 year postoperative;
boolean
C0681850 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Arthroplasty Groups Age
Item
6. all subjects in arthroplasty groups will be between 50-70 years of age
boolean
C0003893 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
Healthy Volunteers
Item
healthy subjects:
boolean
C1708335 (UMLS CUI [1])
Knee pain Absent | Operative procedure on knee Absent | Knee Arthritic change Absent
Item
1. healthy subjects will have no complaints of knee pain or history of knee surgery or known arthritic knee changes.
boolean
C0231749 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0187769 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0022742 (UMLS CUI [3,1])
C0741221 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Arthroplasty Lower Extremity Absent | Systemic disease Absent | Interference Research results Absent
Item
2. all subjects will have no history of prior lower extremity arthroplasty surgeries or systemic disease which could confound outcome measures.
boolean
C0003893 (UMLS CUI [1,1])
C0023216 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C0683954 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Age
Item
3. all healthy persons will be 40-70 years.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bone Support Quantity Insufficient | Bone Support Quality Insufficient | Malignant Neoplasms | Osteotomy Femoral | Osteoporosis | Metabolic Diseases Tissue Calcified
Item
1. insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues;
boolean
C0262950 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231180 (UMLS CUI [1,4])
C0262950 (UMLS CUI [2,1])
C1521721 (UMLS CUI [2,2])
C0332306 (UMLS CUI [2,3])
C0231180 (UMLS CUI [2,4])
C0006826 (UMLS CUI [3])
C0029468 (UMLS CUI [4,1])
C0015811 (UMLS CUI [4,2])
C0029456 (UMLS CUI [5])
C0025517 (UMLS CUI [6,1])
C0040300 (UMLS CUI [6,2])
C0175895 (UMLS CUI [6,3])
Patient unavailable Follow-up X-ray | Patient unavailable Follow-up Clinical Evaluation
Item
2. unable to return for follow up x-rays and clinical evaluation;
boolean
C1301818 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C1301818 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C4084924 (UMLS CUI [2,3])
Comprehension Study Protocol Unable
Item
3. unable to comprehending study protocol for any reason;
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Inflammatory joint disease Systemic | Rheumatoid Arthritis | Communicable Disease | Patient need for Revision Operative procedure on knee
Item
4. systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery;
boolean
C0683381 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C1527075 (UMLS CUI [4,2])
C0187769 (UMLS CUI [4,3])
Immune System Disease | Therapeutic immunosuppression | Disease Response Limited Antigen Stimulus | Adrenal Cortex Hormones Large amount | Cytotoxic agent | Antilymphocytic serum | Therapeutic radiology procedure Dose Large | Therapeutic procedure Preventing Homograft reaction | Acquired Immunodeficiency Syndrome | Autoimmune Diseases
Item
5. subject has an immunological disorder: immunosuppressive treatment characterized by markedly inhibited ability to respond to antigenic stimuli. examples of such conditions include subjects who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), subjects receiving therapy to prevent homograft rejection, subjects who have a documented history of acquired immunodeficiency syndrome (aids), or auto-immune diseases;
boolean
C0021053 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
C1704632 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0003320 (UMLS CUI [3,3])
C0234402 (UMLS CUI [3,4])
C0001617 (UMLS CUI [4,1])
C3869890 (UMLS CUI [4,2])
C0304497 (UMLS CUI [5])
C3826731 (UMLS CUI [6])
C1522449 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0549177 (UMLS CUI [7,3])
C0087111 (UMLS CUI [8,1])
C1292733 (UMLS CUI [8,2])
C1268810 (UMLS CUI [8,3])
C0001175 (UMLS CUI [9])
C0004364 (UMLS CUI [10])
Nervous system problem Influence Biomechanical assessment Body Movement
Item
6. subject has a neurologic condition that would influence the results of biomechanical analysis of whole body movement.
boolean
C0221571 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0846602 (UMLS CUI [1,3])
C0026649 (UMLS CUI [1,4])
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