UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040998 |
|---|---|
| Receipt number | R000046813 |
| Scientific Title | Development and clinical application of next-generation navigation system in osteosynthesis and osteotomy |
| Date of disclosure of the study information | 2020/07/04 |
| Last modified on | 2024/01/06 10:02:45 |
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Basic information
Public title
Development and clinical application of next-generation navigation system in osteosynthesis and osteotomy
Acronym
Next-generation navigation system for osteosynthesis and osteotomy
Scientific Title
Development and clinical application of next-generation navigation system in osteosynthesis and osteotomy
Scientific Title:Acronym
Next-generation navigation system for osteosynthesis and osteotomy
Region
| Japan |
Condition
Condition
Fracture, fracture malunion
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a three-dimensional bone morphology and position estimation system for based on X-ray fluoroscopic images, and a real-time registration system with a 3D preoperative planning image to help osteosynthesis and osteotomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Image evaluations before and after surgery
Key secondary outcomes
Clinical evaluations before and after surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Osteosynthesis and osteotomy using navigation system
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients indicated for osteosynthesis and osteotomy
Key exclusion criteria
Patients with a pathological fractures, deformity of the same bone that may affect the performance of surgery, fractures, osteomyelitis, or patients who are unable to express their intentions due to consciousness disorder, etc.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Yoshii |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Orthopaedic surgery
Zip code
300-0395
Address
3-20-1 Chuo, Ami, Inashiki, Ibaraki, Japan
TEL
0298871161
yyoshii@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Yoshii |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Orthopaedic surgery
Zip code
300-0395
Address
3-20-1 Chuo, Ami, Inashiki, Ibaraki, Japan
TEL
029-887-1161
Homepage URL
yyoshii@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
AMED, Japan Society for the promotion of science, Terumo, JA
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University
Address
6-7-1, Nishishinjuku, Shinjuku, Tokyo, Japan
Tel
03-3342-6111
adm_irb@tokyo-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1. Reproducibility evaluation of 3D preoperative planning based on 3D reference points.
Reproducibility of the 3D preoperative plan for distal radius fracture osteosynthesis were an error of 1.9-2.2 mm.
2. Clinical significance of simple navigation in the osteosynthesis of distal radius fractures
We evaluated the clinical significance of simple navigation for the osteosynthesis of distal radius fractures.The use of simple navigation reduced postoperative radius shortening.
Results date posted
| 2021 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Distal radius fracture and distal humrerus fracture patients
Participant flow
Visit hospital
Adverse events
No
Outcome measures
Reproducibility of reference poiunts, clinical results 3 to 6 months after surgery, X-ray image evaluation
Plan to share IPD
N/A
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 07 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046813
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