UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031875 |
|---|---|
| Receipt number | R000036331 |
| Scientific Title | Analysis of accuracy of navigation system in total hip arthroplasty |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2024/03/28 13:00:31 |
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Basic information
Public title
Analysis of accuracy of navigation system in total hip arthroplasty
Acronym
Analysis of accuracy of navigation system in total hip arthroplasty
Scientific Title
Analysis of accuracy of navigation system in total hip arthroplasty
Scientific Title:Acronym
Analysis of accuracy of navigation system in total hip arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip, idiopathic necrosis of the femoral head, rheumatoid arthritis, femoral neck fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the accuracy of cup orientation in total hip arthroplasty using a CT-based navigation system and a portable navigation system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the accuracy of cup position in total hip arthroplasty between CT-based navigation and portable navigation.
Key secondary 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who satisfy all of the following criteria are targeted.
1) Patients with osteoarthritis of the hip with joint space narrowing, rheumatoid arthritis, idiopathic femoral head necrosis with femoral head collapse, femoral neck fracture.
2) Patients who are over 20 years of age at consent acquisition
3) After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will with sufficient understanding
4) Inpatients
Key exclusion criteria
Patients with any of the following will not be included in this study.
1) Patients with highly deformed ilium due to pelvic fracture, pelvic surgery, etc.
2) Women who may be pregnant or have a possibility of pregnancy
3) Lactating women
4) Patients who are deemed inappropriate by the researchers.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Tetsunaga |
Organization
Okayama University Hospital
Division name
Department of Orthopaedics
Zip code
7008558
Address
2-5-1 Shikata-Cho Kitaku, Okayama, Japan
TEL
086-235-7273
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 Orthopaedics
Zip code
7008558
Address
2-5-1 Shikata-Cho Kitaku, Okayama, Japan
TEL
086-235-7273
Homepage URL
tomonori_t31@yahoo.co.jp
Sponsor or person
Institute
Okayama 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
Okayama University
Address
2-5-1 Shikata-cho, Kitaku, Okayama, Japan
Tel
0862356938
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
| 2018 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32295628/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32295628/
Number of participants that the trial has enrolled
50
Results
CT navigation systems were more accurate in surgeries performed in the lateral position, but no significant difference was observed between the accuracy of portable navigation and CT navigation systems in surgeries performed in the supine position.
Results date posted
| 2024 | Year | 03 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who have hip deformity.
Participant flow
Patients who underwent total hip arthroplasty at Okayama University Hospital.
Adverse events
None
Outcome measures
Navigation absolute error
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 28 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 28 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 28 | Day |
Other
Other related information
Tomonori Tetsunaga MD, PhD
Fepartment of Orthopaedics, Okayama University Hospital
2-5-1 Shikata-Cho Kitaku, Okayama, Japan
Tel: +81-86-235-7273
Fax: +81-86-225-9727
Management information
Registered date
| 2018 | Year | 03 | Month | 24 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036331
