ID

30567

Beschreibung

Effects of Osteotomies Around the Knee on Cartilage Glycosaminoglycan Content Using dGEMRIC Non-invasive Imaging; ODM derived from: https://clinicaltrials.gov/show/NCT01269944

Link

https://clinicaltrials.gov/show/NCT01269944

Stichworte

Versionen (1)
  1. 15.06.18 15.06.18 -
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See clinicaltrials.gov

Hochgeladen am

15. Juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Medial Compartment Osteoarthritis of the Knee NCT01269944

Englisch

Eligibility Medial Compartment Osteoarthritis of the Knee NCT01269944

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
ten patients will be included satisfying the following inclusion criteria:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
both males and females
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
patients >18 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
indication as set by treating physician for operative procedure around the knee: hto (high tibial osteotomy), femoral osteotomy
Beschreibung

Indication Operative procedure on knee | Osteotomy of proximal tibia | Osteotomy of femur

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0187769
UMLS CUI [2]
C0407484
UMLS CUI [3]
C0187780
patient informed consent signed note: patients with previous surgery, history of intra-articular medication, meniscectomy or acl lesions can be included in this study.
Beschreibung

Informed Consent | Operative Surgical Procedures | Pharmaceutical Preparations Intraarticular | Meniscectomy | Anterior Cruciate Ligament Lesion

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0543467
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1522204
UMLS CUI [4]
C0187901
UMLS CUI [5,1]
C0078960
UMLS CUI [5,2]
C0221198
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following patients are excluded from participating in this study:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
known anaphylactic reactions to gadolinium or related substances
Beschreibung

Anaphylaxis Gadolinium | Anaphylaxis Gadolinium Related Substance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0016911
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0016911
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0439861
kidney diseases with a creatinin excretion of < 20 ml/min
Beschreibung

Kidney Diseases | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
risk groups for mri scanning due to magnetic field or contrast agent (9, 10): metal in body: pacemaker / aicd / icd (coronary defibrillator), nervus vagus (x) stimulator, artificial heart valve (depending on type), metal clips on cerebral arteries or veins, metal particles in eye, port-a-cath, metal stents, hydrocephalic pump / insuline pump, metal implants; f/e screws, prostheses, piercings.
Beschreibung

Risk Groups Magnetic Resonance Imaging | Risk Due to Magnetic Fields | Risk Due to Contrast Media | Metal Body | Artificial cardiac pacemaker | Automatic Implantable Cardioverter-Defibrillators | Implantable defibrillator | Vagal nerve stimulator | Artificial heart valve | Clip Metallic Cerebral artery | Clip Metallic Veins | Particles Metallic Eye | Port-A-Cath | Metal stent | Pumps, Hydrocephalic | Insulin pump | Metallic device / implant | Screw | Prosthesis | Piercing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0441833
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0563533
UMLS CUI [3,1]
C0035647
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0009924
UMLS CUI [4,1]
C0025552
UMLS CUI [4,2]
C1268086
UMLS CUI [5]
C0030163
UMLS CUI [6]
C0972395
UMLS CUI [7]
C0162589
UMLS CUI [8]
C2959478
UMLS CUI [9]
C1399223
UMLS CUI [10,1]
C0175722
UMLS CUI [10,2]
C2986473
UMLS CUI [10,3]
C0007770
UMLS CUI [11,1]
C0175722
UMLS CUI [11,2]
C2986473
UMLS CUI [11,3]
C0042449
UMLS CUI [12,1]
C0597177
UMLS CUI [12,2]
C2986473
UMLS CUI [12,3]
C0015392
UMLS CUI [13]
C3495140
UMLS CUI [14]
C0441290
UMLS CUI [15]
C1736936
UMLS CUI [16]
C1140609
UMLS CUI [17]
C3693688
UMLS CUI [18]
C0301559
UMLS CUI [19]
C0175649
UMLS CUI [20]
C1446587
claustrofibia
Beschreibung

Claustrophobia

Datentyp

boolean

Alias
UMLS CUI [1]
C0008909
first three months of pregnancy (not sufficient information available about effects of contrast agent on foetal development in this stage). patients will be asked if they may be pregnant (< 3 months of pregnancy): if uncertain, they will be excluded.
Beschreibung

Pregnancy Month Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0439231
UMLS CUI [1,3]
C1265611
contra-indications for mri scanning, as well as contra-indications to intra-venous administration of contrast agents were discussed with ms. shanta kalaykhan-sewradj, head of mri technicians in the umc utrecht. for further information, the booklet 'bijwerkingen van contrastmiddelen: de gadoliniumverbindingen' by esther ensing and janet hoven was used (published by nederlandse vereniging voor slachtoffers van medische contrastmiddelen, 2004).
Beschreibung

Medical contraindication Magnetic Resonance Imaging | Medical contraindication Contrast Media Intravenous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0009924
UMLS CUI [2,3]
C1522726
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Ähnliche Modelle

Eligibility Medial Compartment Osteoarthritis of the Knee NCT01269944

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
ten patients will be included satisfying the following inclusion criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Gender
Item
both males and females
boolean
C0079399 (UMLS CUI [1])
Age
Item
patients >18 years old
boolean
C0001779 (UMLS CUI [1])
Indication Operative procedure on knee | Osteotomy of proximal tibia | Osteotomy of femur
Item
indication as set by treating physician for operative procedure around the knee: hto (high tibial osteotomy), femoral osteotomy
boolean
C3146298 (UMLS CUI [1,1])
C0187769 (UMLS CUI [1,2])
C0407484 (UMLS CUI [2])
C0187780 (UMLS CUI [3])
Informed Consent | Operative Surgical Procedures | Pharmaceutical Preparations Intraarticular | Meniscectomy | Anterior Cruciate Ligament Lesion
Item
patient informed consent signed note: patients with previous surgery, history of intra-articular medication, meniscectomy or acl lesions can be included in this study.
boolean
C0021430 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1522204 (UMLS CUI [3,2])
C0187901 (UMLS CUI [4])
C0078960 (UMLS CUI [5,1])
C0221198 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
the following patients are excluded from participating in this study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Anaphylaxis Gadolinium | Anaphylaxis Gadolinium Related Substance
Item
known anaphylactic reactions to gadolinium or related substances
boolean
C0002792 (UMLS CUI [1,1])
C0016911 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0016911 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0439861 (UMLS CUI [2,4])
Kidney Diseases | Creatinine measurement, serum
Item
kidney diseases with a creatinin excretion of < 20 ml/min
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Risk Groups Magnetic Resonance Imaging | Risk Due to Magnetic Fields | Risk Due to Contrast Media | Metal Body | Artificial cardiac pacemaker | Automatic Implantable Cardioverter-Defibrillators | Implantable defibrillator | Vagal nerve stimulator | Artificial heart valve | Clip Metallic Cerebral artery | Clip Metallic Veins | Particles Metallic Eye | Port-A-Cath | Metal stent | Pumps, Hydrocephalic | Insulin pump | Metallic device / implant | Screw | Prosthesis | Piercing
Item
risk groups for mri scanning due to magnetic field or contrast agent (9, 10): metal in body: pacemaker / aicd / icd (coronary defibrillator), nervus vagus (x) stimulator, artificial heart valve (depending on type), metal clips on cerebral arteries or veins, metal particles in eye, port-a-cath, metal stents, hydrocephalic pump / insuline pump, metal implants; f/e screws, prostheses, piercings.
boolean
C0035647 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0035647 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0563533 (UMLS CUI [2,3])
C0035647 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0009924 (UMLS CUI [3,3])
C0025552 (UMLS CUI [4,1])
C1268086 (UMLS CUI [4,2])
C0030163 (UMLS CUI [5])
C0972395 (UMLS CUI [6])
C0162589 (UMLS CUI [7])
C2959478 (UMLS CUI [8])
C1399223 (UMLS CUI [9])
C0175722 (UMLS CUI [10,1])
C2986473 (UMLS CUI [10,2])
C0007770 (UMLS CUI [10,3])
C0175722 (UMLS CUI [11,1])
C2986473 (UMLS CUI [11,2])
C0042449 (UMLS CUI [11,3])
C0597177 (UMLS CUI [12,1])
C2986473 (UMLS CUI [12,2])
C0015392 (UMLS CUI [12,3])
C3495140 (UMLS CUI [13])
C0441290 (UMLS CUI [14])
C1736936 (UMLS CUI [15])
C1140609 (UMLS CUI [16])
C3693688 (UMLS CUI [17])
C0301559 (UMLS CUI [18])
C0175649 (UMLS CUI [19])
C1446587 (UMLS CUI [20])
Claustrophobia
Item
claustrofibia
boolean
C0008909 (UMLS CUI [1])
Pregnancy Month Quantity
Item
first three months of pregnancy (not sufficient information available about effects of contrast agent on foetal development in this stage). patients will be asked if they may be pregnant (< 3 months of pregnancy): if uncertain, they will be excluded.
boolean
C0032961 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Medical contraindication Magnetic Resonance Imaging | Medical contraindication Contrast Media Intravenous
Item
contra-indications for mri scanning, as well as contra-indications to intra-venous administration of contrast agents were discussed with ms. shanta kalaykhan-sewradj, head of mri technicians in the umc utrecht. for further information, the booklet 'bijwerkingen van contrastmiddelen: de gadoliniumverbindingen' by esther ensing and janet hoven was used (published by nederlandse vereniging voor slachtoffers van medische contrastmiddelen, 2004).
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0009924 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
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