UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040072 |
|---|---|
| Receipt number | R000045663 |
| Scientific Title | Clinical Evaluation of the usefulness of CT-based navigation system in transposition osteotomy of acetabulum |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2022/04/08 09:11:28 |
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Basic information
Public title
Clinical Evaluation of the usefulness of CT-based navigation system in transposition osteotomy of acetabulum
Acronym
The usefulness of navigation system in TOA
Scientific Title
Clinical Evaluation of the usefulness of CT-based navigation system in transposition osteotomy of acetabulum
Scientific Title:Acronym
The usefulness of navigation system in TOA
Region
| Japan |
Condition
Condition
Osteoarthritis secondary to hip dysplasia
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the usefulness of CT-based navigation system in transposition osteotomy of acetabulum by comparing the accuracy of the osteotomy and the clinical results with those of the conventional method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the difference between the preoperative planning and the actual osteotomy line.
Key secondary outcomes
To evaluate the difference in three-dimensional acetabular coverage of the femoral head between postoperative CT and preoperative planning. To evaluate physical activity and hip function preoperatively and at 1-year postoperatively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
transposition osteotomy of acetabulum in conventional method
Interventions/Control_2
transposition osteotomy of acetabulum using CT-based navigation system
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
| 16 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age: 16 to 60 years-old
2) Male and Female
3) Patients with the ability of consent and writing. If a patient is under 20 years-old, his/her patients with the ability of consent and writing.
4) Patients who can visit hospital as scheduled during the research period
Key exclusion criteria
1) Patients with immature bone structure
2) Suspicious patients with metal allergy
3) Pregnant patients, pregnant suspicious patients, or patients who hope for pregnancy
4) Patients with the disease which can affect consent or evaluation of the study, including dementia, schizophrenia, depression, panic disorder, or generalized anxiety disorder
5) Patients who doctors judged unsuitable for the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Nakashima |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Orthopaedic Surgery
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
0926425488
yasunaka@ortho.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Goro |
| Middle name | |
| Last name | Motomura |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Orthopaedic Surgery
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
0926425488
Homepage URL
goromoto@ortho.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Section of IRB & Ethics Committee Administration, Academic Research Support Division, Kyushu University Hospital
Address
3-1-1, Maidashi, Higashi-ku
Tel
0926425082
byskenkyu@jimu.kyushu-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 04 | Month | 06 | Day |
Last modified on
| 2022 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045663
