ID

18671

Description

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

Link

https://clinicaltrials.gov/show/NCT00243295

Keywords

  1. 11/15/16 11/15/16 -
Uploaded on

November 15, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Osteoarthritis NCT00243295

Eligibility Osteoarthritis NCT00243295

Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

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.
Description

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

Data type

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.
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Data type

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.
Description

Inclusion

Data type

boolean

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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.
Description

Operative Surgical Procedure Planned Knee Opposite

Data type

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.
Description

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

Data type

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.
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251

Similar models

Eligibility Osteoarthritis NCT00243295

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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