UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052159 |
|---|---|
| Receipt number | R000059531 |
| Scientific Title | Reproduce the screw head position of percutaneous pedicle screws outside the body by parallel adjusters and tab sticks |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/09/09 16:10:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Reproduce the screw head position of percutaneous pedicle screws outside the body by parallel adjusters and tab sticks
Acronym
A simple device that reproduces the position of the PPS screw head outside the body.
Scientific Title
Reproduce the screw head position of percutaneous pedicle screws outside the body by parallel adjusters and tab sticks
Scientific Title:Acronym
A simple device that reproduces the position of the PPS screw head outside the body.
Region
| Japan |
Condition
Condition
Vertebral fracture, Pyogenic spondylitis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have developed a highly versatile device that easily reproduces the screw head arrangement in vitro. In this study, we report the theory and technique of this device, as well as the initial treatment results.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
early back-out, screw loosening
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A study initiated in June 2021 examined twenty cases where this system was employed across five or more intervertebral spaces.
Key exclusion criteria
non
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Itoi |
Organization
Juntendo University. Shizuoka Hospital
Division name
Department of Orthopaedic Surgery
Zip code
4102211
Address
Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan
TEL
0559483111
aitoi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | AKIRA |
| Middle name | |
| Last name | ITOI |
Organization
Juntendo University. Shizuoka Hospital
Division name
Department of Orthopaedic Surgery
Zip code
410-2211
Address
Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan
TEL
0559483111
Homepage URL
aitoi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Akira Itoi
Funding Source
Organization
Own resources
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
Department of Orthopaedic Surgery., Juntendo University. Shizuoka Hospital
Address
Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan
Tel
0559483111
aitoi@juntendo.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
| 2023 | Year | 11 | 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
20
Results
There were no early back-outs. Screw loosening was identified in 9 of the 11 cases (82%).
Results date posted
| 2023 | Year | 09 | Month | 09 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2023 | Year | 09 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059531
