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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033222
Receipt No. 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

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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
Email 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
Email ojima@ka2.so-net.ne.jp

Sponsor
Institute Fukui General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037882

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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