UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059347 |
|---|---|
| Receipt number | R000067457 |
| Scientific Title | Radiographic Outcomes of Knees Operated According to the Indications for Cementless Total Knee Arthroplasty |
| Date of disclosure of the study information | 2025/10/09 |
| Last modified on | 2025/10/09 06:23:31 |
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Basic information
Public title
Radiographic Outcomes of Knees Operated According to the Indications for Cementless Total Knee Arthroplasty: Is There a Difference in Radiolucent Lines?
Acronym
the Indications for Cementless Total Knee Arthroplasty
Scientific Title
Radiographic Outcomes of Knees Operated According to the Indications for Cementless Total Knee Arthroplasty
Scientific Title:Acronym
the Indications for Cementless Total Knee Arthroplasty
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Radiographic Evaluation of Total Knee Arthroplasty Performed Based on a New Cementless Indication Criteria
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the incidence of radiolucent lines at one year postoperatively in knees operated according to the proposed indication criteria.
Key secondary outcomes
(1) Clinical outcomes at one year postoperatively, including the 2011 Knee Score, FJS-12, or other PROMs; (2) presence of early loosening, assessed by the rate of subsidence; and (3) the relationship between step count and the incidence of radiolucent lines.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cementless fixation is selected for knees with a preoperative tibial bone mineral density of 46.7 or higher on CT, while cemented fixation is chosen for knees with a density below 46.7.
Key exclusion criteria
Severely valgus knees requiring stem extension, knees requiring augmentation, and knees with more than 11 mm of lateral tibial resection
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
198-0021
Address
Imadera 5-18-19, Oume City, Tokyo
TEL
08020926874
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
Self funding
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
ymikashima2007@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 02 | Month | 01 | Day |
Other
Other related information
We hypothesize that performing surgery based on the indication criteria for cementless total knee arthroplasty (TKA) will result in (1) a reduced incidence of radiolucent lines in cementless TKA, and (2) a minimal occurrence of radiolucent lines even in cemented TKA. This study aims to verify the validity of this hypothesis.
Management information
Registered date
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067457
