UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061295 |
|---|---|
| Receipt number | R000070136 |
| Scientific Title | A Prospective Randomized Controlled Trial Comparing Implant Positioning Accuracy Between CT-Based Navigation Systems in Total Hip Arthroplasty |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/17 18:41:01 |
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Basic information
Public title
Comparison of Two CT-Based Navigation Systems in Total Hip Arthroplasty
Acronym
THA-Navi Trial
Scientific Title
A Prospective Randomized Controlled Trial Comparing Implant Positioning Accuracy Between CT-Based Navigation Systems in Total Hip Arthroplasty
Scientific Title:Acronym
THA-Navi Trial
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip, osteonecrosis of the femoral head, and femoral neck fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the implant positioning accuracy between two CT-based navigation systems (Stryker and Nakashima Health Force) in total hip arthroplasty.
Basic objectives2
Others
Basic objectives -Others
No additional basic objectives are specified in this study.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Absolute error between planned and postoperative cup anteversion measured on CT within 2 weeks after surgery
Key secondary outcomes
Absolute error of cup inclination measured on CT within 2 weeks after surgery,
Femoral head center position,
Clinical outcomes (Modified Harris Hip Score),
Patient-reported outcomes (JHEQ, JOANR THA PROMs),
Postoperative complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Total hip arthroplasty will be performed using the Stryker CT-based navigation system. The navigation system will be used intraoperatively for implant positioning within the standard surgical procedure.
Interventions/Control_2
Total hip arthroplasty will be performed using the Nakashima Health Force CT-based navigation system. The navigation system will be used intraoperatively for implant positioning within the standard surgical procedure.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for primary total hip arthroplasty,
Patients who provide written informed consent
Key exclusion criteria
Revision total hip arthroplasty,
Cemented cup cases,
Patients with prior pelvic osteotomy or pelvic trauma
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Takeda |
Organization
Hyogo Medical University
Division name
Department of Orthopaedic Surgery
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
TEL
(0798)45-6452
takeda.yu.0127@gmail.com
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Takeda |
Organization
Hyogo Medical University
Division name
Department of Orthopaedic Surgery
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
(0798)45-6452
Homepage URL
takeda.yu.0127@gmail.com
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board, Hyogo Medical University
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
(0798)45-6164
rss-adm@hyo-med.ac.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
兵庫医科大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | 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 | 05 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 17 | Day |
Last modified on
| 2026 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070136
