UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059017 |
|---|---|
| Receipt number | R000067496 |
| Scientific Title | Intraoperative Fluoroscopic Evaluation of Stem Anteversion in Total Hip Arthroplasty |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/06 10:45:58 |
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Basic information
Public title
Intraoperative Fluoroscopic Evaluation of Stem Anteversion in Total Hip Arthroplasty
Acronym
Intraoperative Fluoroscopic Evaluation of Stem Anteversion in Total Hip Arthroplasty
Scientific Title
Intraoperative Fluoroscopic Evaluation of Stem Anteversion in Total Hip Arthroplasty
Scientific Title:Acronym
Intraoperative Fluoroscopic Evaluation of Stem Anteversion in Total Hip Arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip and osteonecrosis of the femoral head
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate whether the use of intraoperative fluoroscopy, aligned with the transverse axis of the stem, could improve the accuracy of implantation by reducing discrepancies from the preoperative plan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
implantation error of the stem
Key secondary outcomes
expand of the surgical time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The stem is aligned with the axis under intraoperative fluoroscopy, and its implantation is performed after confirming that the appearances of the greater and lesser trochanters are comparable to the preoperative plan and within the acceptable range
Interventions/Control_2
Absence of fluoroscopic guidance for determining intraoperative stem anteversion.
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases of total hip arthroplasty performed at Niigata University Medical and Dental Hospital and Tsubokawa General Hospital after approval by the institutional review boards and before July 31, 2027.
Key exclusion criteria
Exclusion criteria were as follows:
Use of a cemented stem
Intraoperative fracture
Patients who refused participation in the study or survey
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | IMAI |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Comprehensive Musculoskeletal Medicine,
Zip code
951-8510
Address
1-757, Asahimachido-ri, Niigata City, Japan
TEL
0252272272
imainorio2001@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | IMAI |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Comprehensive Musculoskeletal Medicine,
Zip code
951-8510
Address
1-757 Asahimachi-dori, Niigata City, Japan
TEL
0252272272
Homepage URL
imainorio2001@yahoo.co.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
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
Niigata University
Address
1-757, Asahimachido-ri, Niigata City, Japan
Tel
0252272272
imainorio2001@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 | 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
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | 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
Management information
Registered date
| 2025 | Year | 09 | Month | 06 | Day |
Last modified on
| 2025 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067496
