UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056520 |
|---|---|
| Receipt number | R000064587 |
| Scientific Title | Relationship between cement viscosity and mantle thickness |
| Date of disclosure of the study information | 2024/12/23 |
| Last modified on | 2025/12/24 06:19:09 |
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Basic information
Public title
Relationship between cement viscosity and mantle thickness
Acronym
Relationship between cement viscosity and mantle thickness
Scientific Title
Relationship between cement viscosity and mantle thickness
Scientific Title:Acronym
Relationship between cement viscosity and mantle thickness
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the relationship between tibial bone density and cement mantle thickness using cements of two different viscosities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The Modern Knee Society Radiographic Evaluation System is used to investigate how thick the cement mantle has formed in each zone of the tibia.
Key secondary outcomes
The relationship between cement viscosity and tibial bone mineral density is investigated.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
total knee arthroplasty using high-viscosity cement
Interventions/Control_2
total knee arthroplasty using low-viscosity cement
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
| 70 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients over 70 years old with osteoporosis. Those of BMI less than 30.
Key exclusion criteria
Patients under 70 years old and those of BMI over 30 are excluded
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Mikashima |
Organization
Takagi Hospital
Division name
Oume Knee Surgery Center
Zip code
198-0022
Address
Imadera 5-18-19, Oume City, Tokyo
TEL
0428315255
ymikashima2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Mikashima |
Organization
Takagi Hospital
Division name
Oume Knee Surgery Center
Zip code
198-0021
Address
Imadera 5-18-19, Oume City, Tokyo
TEL
0428315255
Homepage URL
https://www.takagi-hp.or.jp/
ymikashima2007@yahoo.co.jp
Sponsor or person
Institute
Takagi Hospital Oume Knee Surgery Center
Institute
Department
Personal name
Yoshinori Mikashima
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takagi Hospital
Address
Imadera 5-18-19, Oume City, Tokyo
Tel
0428315255
yamazaki@takagi-hp.or.jp
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
高木病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 24 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 24 | Day |
Date analysis concluded
| 2026 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2025 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064587
