UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044198 |
|---|---|
| Receipt number | R000050470 |
| Scientific Title | Accuracy comparison analysis of cup placement in total hip arthroplasty |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2024/11/18 06:37:40 |
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Basic information
Public title
Accuracy comparison analysis of cup placement in total hip arthroplasty
Acronym
Accuracy comparison analysis in total hip arthroplasty
Scientific Title
Accuracy comparison analysis of cup placement in total hip arthroplasty
Scientific Title:Acronym
Accuracy comparison analysis in total hip arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis, rheumatoid arthritis,osteonecrosis of the femoral head, femoral neck fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prospectively compare the accuracy of implant placement with a portable navigation system or alignment guide for patients undergoing total hip arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of acetabular component (anteversion, inclination)
Key secondary outcomes
Complications, surgery time, bleeding volume, clinical score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform surgery using alignment guide during total hip arthroplasty
Interventions/Control_2
Perform surgery using a portable navigation system during total hip arthroplasty
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For patients who meet all of the following criteria
1) Patients with osteoarthritis of the hip and rheumatoid arthritis with narrowing of the joint space by plain X-ray, patients with necrosis of the femoral head with collapsing of the femoral head by plain X-ray, and patients with femoral neck fracture.
2) Patients aged 20 years or older at the time of consent acquisition
3) Patients who received sufficient explanation before participating in this study, and obtained written consent by the patient himself / herself with sufficient understanding.
4) Inpatients
Key exclusion criteria
Patients who violate any of the following will not be included in this study
1) Patients with severe iliac deformity due to pelvic fracture, pelvic surgery, etc.
2) Women who are pregnant or may become pregnant
3) Lactating women
4) Patients who are judged by the principal investigator and the research coordinator to be inappropriate as research subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Tetsunaga |
Organization
Okayama University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kitaku, Okayama
TEL
0862357273
tomonori_t31@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Tetsunaga |
Organization
Okayama University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kitaku, Okayama
TEL
0862357273
Homepage URL
tomonori_t31@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University
Address
2-5-1 Shikata-cho, Kitaku, Okayama
Tel
0862357273
tomonori_t31@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
| 2021 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2021 | Year | 05 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050470
