ID

18671

Descripción

Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies; ODM derived from: https://clinicaltrials.gov/show/NCT00243295

Link

https://clinicaltrials.gov/show/NCT00243295

Palabras clave

Versiones (1)
  1. 15/11/16 15/11/16 -
Subido en

15 de noviembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00243295

Inglés

Eligibility Osteoarthritis NCT00243295

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects 45 to 70 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment oa of the knee.
Descripción

Osteoarthritis Medial compartment of knee Correction | Wedge osteotomy Tibial Open Successful

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0447799
UMLS CUI [1,3]
C1947976
UMLS CUI [2,1]
C0185153
UMLS CUI [2,2]
C0040184
UMLS CUI [2,3]
C0175566
UMLS CUI [2,4]
C1272703
female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for owo and agree to use medically approved contraception for the duration of the study.
Descripción

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
other inclusion applies.
Descripción

Inclusion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results.
Descripción

Pre-existing condition Knee Interferes with Interpretation of results | Pre-existing condition Tibia Interferes with Interpretation of results

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0521987
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C3526596
UMLS CUI [2,1]
C0521987
UMLS CUI [2,2]
C0040184
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C3526596
subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up.
Descripción

Operative Surgical Procedure Planned Knee Opposite

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0022742
UMLS CUI [1,4]
C1521805
subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma.
Descripción

Malignant Neoplasms | Therapeutic radiology procedure Malignant Neoplasms | Chemotherapy Malignant Neoplasms | Basal cell carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0006826
UMLS CUI [4]
C0007117
other exclusion applies.
Descripción

Exclusion Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
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Similar models

Eligibility Osteoarthritis NCT00243295

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female subjects 45 to 70 years of age
boolean
C0001779 (UMLS CUI [1])
Osteoarthritis Medial compartment of knee Correction | Wedge osteotomy Tibial Open Successful
Item
within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment oa of the knee.
boolean
C0029408 (UMLS CUI [1,1])
C0447799 (UMLS CUI [1,2])
C1947976 (UMLS CUI [1,3])
C0185153 (UMLS CUI [2,1])
C0040184 (UMLS CUI [2,2])
C0175566 (UMLS CUI [2,3])
C1272703 (UMLS CUI [2,4])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for owo and agree to use medically approved contraception for the duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Inclusion
Item
other inclusion applies.
boolean
C1512693 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pre-existing condition Knee Interferes with Interpretation of results | Pre-existing condition Tibia Interferes with Interpretation of results
Item
subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results.
boolean
C0521987 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C3526596 (UMLS CUI [1,4])
C0521987 (UMLS CUI [2,1])
C0040184 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C3526596 (UMLS CUI [2,4])
Operative Surgical Procedure Planned Knee Opposite
Item
subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up.
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C1521805 (UMLS CUI [1,4])
Malignant Neoplasms | Therapeutic radiology procedure Malignant Neoplasms | Chemotherapy Malignant Neoplasms | Basal cell carcinoma
Item
subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma.
boolean
C0006826 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0007117 (UMLS CUI [4])
Exclusion Criteria
Item
other exclusion applies.
boolean
C0680251 (UMLS CUI [1])
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