UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060825 |
|---|---|
| Receipt number | R000069086 |
| Scientific Title | Effectiveness of Robotic TKA in medial pivot design |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/01/17 14:24:44 |
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Basic information
Public title
Effectiveness of Robotic TKA in medial pivot design
Acronym
Robotic MP-TKA study
Scientific Title
Effectiveness of Robotic TKA in medial pivot design
Scientific Title:Acronym
Robotic MP-TKA study
Region
| Japan |
Condition
Condition
Knee disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the outcomes of robotic-assisted TKA with medial pivot TKA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PROMs
Key secondary outcomes
Other clinical or radiological outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with knee osteoarthritis (Knee OA) requiring total knee arthroplasty (TKA)
Key exclusion criteria
TKA for other diseases such as RA
Patients who have mental diseases
Patients who withdrew from the study
Patients with insufficient intraoperative data collection
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ueyama |
Organization
Koryokai hospital
Division name
Orthopedics
Zip code
5470044
Address
Hiranohonmachi 4-15-6, Hirano, Osaka, Japan
TEL
06-6791-0928
ueyama.rosai@gmail.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ueyama |
Organization
Koryokai Hospital
Division name
Orthopedics
Zip code
5470044
Address
Hiranohonmachi 4-15-6, Hirano, Osaka, Japan
TEL
06-6791-0928
Homepage URL
ueyama.rosai@gmail.com
Sponsor or person
Institute
Koryokai hopsital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Koryokai hospital
Address
Hiranohonmachi 4-15-6, Hirano, Osaka, Japan
Tel
06-6791-0928
ueyama.rosai@gmail.com
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
| 2026 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient reported outcome measures, PROMs, after TKA have attracted increasing attention as an area requiring improvement, and several studies have suggested that TKA using medial pivot type implants is advantageous for improving postoperative PROMs. More recently, surgical concepts such as functional alignment TKA, which aims to reproduce patient-specific soft tissue balance using robotic assistance, have gained recognition, and there are reports indicating that robot assisted surgery itself contributes to improvements in PROMs. However, current outcome reports on robot assisted TKA are limited to specific implant systems, and to date, no studies have evaluated the outcomes of combining robotic assistance with a purely medial pivot designed TKA implant. The purpose of this study was to perform TKA using a combination of a medial pivot type implant and robotic assistance and to evaluate the resulting clinical outcomes.
Management information
Registered date
| 2026 | Year | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069086
