UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033222 |
|---|---|
| Receipt number | R000037882 |
| Scientific Title | Clinical Results of Prophylactic Iodine-supported Primary TKA for Compromised Cases |
| Date of disclosure of the study information | 2018/07/02 |
| Last modified on | 2018/07/01 21:44:53 |
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Basic information
Public title
Clinical Results of Prophylactic Iodine-supported Primary TKA for Compromised Cases
Acronym
Prophylactic Iodine-supported Primary TKA
Scientific Title
Clinical Results of Prophylactic Iodine-supported Primary TKA for Compromised Cases
Scientific Title:Acronym
Prophylactic Iodine-supported Primary TKA
Region
| Japan |
Condition
Condition
Osteoarthritis, Rheumatoid arthritis of knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate potential with iodine-support for primary total knee arthroplasty for patients under several compromised status
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood serum test
Urinary iodine excretion
thyroid hormone
before surgery and at 1, 6 months, and 1, 3 years after surgery
Key secondary outcomes
postoperative roentgenogram
adverse effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
prophylactic iodine-suported primaru TKA
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)more than grade 3 by Kellgren-Lawrence
classification for OA
more than grade3 by Larsen
classification for RA
(2)having following risk factors of PJI
a history of pyogenic arthritis
severe DM(HbA1c>7%)
positive inflammatory markers
(CRP>0.5mg/dL) due to RA etc.
inactive infections in other organs
bearing cancer
under chemotherapy including high dose
glucocorticoid(>10mg/day)
hyperobesity (BMI>40)
Key exclusion criteria
a known allergy or hypersensitivity reaction against iodine based on the medical history
simultaneous bilateral or revision TKA
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Ojima |
Organization
Fukui General Hospital
Division name
Dept. of Orthopaedic Surgery
Zip code
Address
58-16-1, Egami, Fukui
TEL
0776-59-1300
ojima@ka2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Ojima |
Organization
Fukui General Hospital
Division name
Dept. of Orthopaedic Surgery
Zip code
Address
58-16-1, Egami, Fukui
TEL
0776-59-1300
Homepage URL
ojima@ka2.so-net.ne.jp
Sponsor or person
Institute
Fukui General Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukui General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 01 | Day |
Last modified on
| 2018 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037882
