UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033082 |
|---|---|
| Receipt number | R000033847 |
| Scientific Title | Clinical trial on the effect of difference in surgical procedure for treating adult spinal deformity |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2023/06/25 18:24:35 |
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Basic information
Public title
Clinical trial on the effect of difference in surgical procedure for treating adult spinal deformity
Acronym
Clinical trial on the effect of difference in surgical procedure for treating adult spinal deformity
Scientific Title
Clinical trial on the effect of difference in surgical procedure for treating adult spinal deformity
Scientific Title:Acronym
Clinical trial on the effect of difference in surgical procedure for treating adult spinal deformity
Region
| Japan |
Condition
Condition
Adult spinal deformity
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the correction rate and corrective maintenance of hybrid surgical approach to those of the MIS approach on treating adult spinal deformity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radiographic outcomes and QOL improvement rate at the 24 months follow-up
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are diagnosed as adult spinal deformity and are an applicable to lumber interbody fusion.
2. Subjects who fall under any of Cobb angle more than 20 degrees, PT 20 degree, SVA 50mm, or TPA 20 degrees on pre-operation.
3. Upper instrumented vertebra is above L2, and any one of S2AI screw, iliac screw or LSIT can be used on lower instrumented vertebra.
4. Subjects over 45 year of age.
5. Subjects capable of reading and understanding Japanese.
6. Subject who can provide voluntary informed consent.
Key exclusion criteria
1. Subjects who have had spinal fixation.
2. Subjects who are pregnant or will be possibly pregnant.
3. Subjects who have an allergy to nickel, chromium, or Titanium alloy.
4. Subjects who have an actively spinal infection.
5. Subjects who are an inappropriate for participating in the study in the judgement of the investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsushi Takeshita |
Organization
Jichi Medical University Hospital
Division name
Orthopaedics
Zip code
Address
3311-1, Yakushiji, Shimotsuke-shi, Tochigi
TEL
0285-44-2111
dtstake@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Komori |
Organization
Stryker Japan K.K.
Division name
Clinical Affairs
Zip code
Address
2-6-1, Koraku, Bunkyo-ku, Tokyo
TEL
03-6894-8394
Homepage URL
NSKclinicaltrial@stryker.com
Sponsor or person
Institute
Stryker Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Stryker Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 07 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- Radiographic evaluation
- Oswestry Disability Index
- SRS-22
- Numeric Rating Scale
- the presence of PJK/PJF
Management information
Registered date
| 2018 | Year | 06 | Month | 21 | Day |
Last modified on
| 2023 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033847
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
