UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057178 |
|---|---|
| Receipt number | R000065295 |
| Scientific Title | A single center prospective comparative observational study on early postoperative clinical outcomes in total knee arthroplasty using the ROSA Recon robotic system (vs Portable Navi) |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2026/03/16 16:22:42 |
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Basic information
Public title
Prospective comparative observational study in total knee arthroplasty using Navigation system or ROSA Recon robotic system
Acronym
ROSA Comparison Study
Scientific Title
A single center prospective comparative observational study on early postoperative clinical outcomes in total knee arthroplasty using the ROSA Recon robotic system (vs Portable Navi)
Scientific Title:Acronym
ROSA Comparison Study
Region
| Japan |
Condition
Condition
Knee Joint Diseases
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare early postoperative clinical outcomes between ROSA-assisted TKA and navigation-assisted TKA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Group differences in 2011 KSS (Functional Knee Score) at 1 year after surgery
Key secondary outcomes
KSS 2011 (MCID, improvement rate, objective knee score), Range Of Motion, Gait Speed and asymmetry, incidence of soft tissue release and adverse event
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- 18 years and over.
- Skeletally mature
- Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent
- Willing and able to complete scheduled follow-up evaluations as defined in the study protocol
Key exclusion criteria
- Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft
- Is septic, has an active infection or has osteomyelitis at the affected joint and/or other local/systemic infection that may affect the prosthetic joint
- Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
- Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- Scheduled to undergo bilateral simultaneous TKA
- Severe instability secondary to the absence of collateral ligament integrity
- Pregnant patients, mentally ill patients, and other patients who the PIs determines may affect consent, safety, and evaluation
- Is participating in any other surgical intervention studies or pain management studies at the time of informed consent
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kiyonori |
| Middle name | |
| Last name | Mizuno |
Organization
Anshin Hospital
Division name
Department of Orthopaedic Surgery
Zip code
650-0047
Address
1-4-12 Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan
TEL
080-9273-6811
noriko.sugawara@zimmerbiomet.com
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Sugawara |
Organization
Zimmer Biomet G.K.
Division name
Clinical Affairs
Zip code
108-0073
Address
3-5-19 Mita, Minato-ku, Tokyo, Japan
TEL
080-9273-6811
Homepage URL
noriko.sugawara@zimmerbiomet.com
Sponsor or person
Institute
Zimmer Biomet G.K.
Institute
Department
Personal name
Funding Source
Organization
Zimmer Biomet G.K.
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
Anshin Hospital Ethics Review Committee
Address
1-4-12 Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, Japan
Tel
078-304-5252
noriko.sugawara@zimmerbiomet.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
| 2025 | Year | 02 | Month | 28 | 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 | 11 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 05 | Month | 31 | Day |
Other
Other related information
Patients who are deemed to require TKA between March 2025 and March 2026 and meet the eligibility criteria
Assessment items: 2011 KSS, FJS-12, knee joint ROM, TUG, muscle strength, walking ability
Management information
Registered date
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065295
