UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061144 |
|---|---|
| Receipt number | R000069944 |
| Scientific Title | Incidence and Associated Factors of Mechanical Complications After Spinal Fusion Surgery |
| Date of disclosure of the study information | 2026/04/03 |
| Last modified on | 2026/04/03 09:17:54 |
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Basic information
Public title
Incidence and Associated Factors of Mechanical Complications After Spinal Fusion Surgery
Acronym
Investigation of Mechanical Complications After Spinal Fusion Surgery
Scientific Title
Incidence and Associated Factors of Mechanical Complications After Spinal Fusion Surgery
Scientific Title:Acronym
Investigation of Mechanical Complications After Spinal Fusion Surgery
Region
| Japan |
Condition
Condition
Degenerative spinal disorders (including lumbar spinal stenosis, degenerative spondylolisthesis, and adult spinal deformity)
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the incidence of mechanical complications following spinal fusion surgery and to identify associated clinical and surgical factors.
Basic objectives2
Others
Basic objectives -Others
Epidemiological study investigating incidence and associated factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of postoperative mechanical complications
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･Patients who underwent spinal fusion surgery at our institution
･Surgery performed between April 2017 and March 2022
･Patients with at least 1 year of postoperative follow-up
Key exclusion criteria
Patients who declined participation (opt-out)
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Teraguchi |
Organization
Wakayama Medical University
Division name
Department of Orthopaedic Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama-shi, Wakayama, Japan
TEL
+81-73-447-2300
m-tera@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Nakagawa |
Organization
Wakayama Medical University Hospital
Division name
Department of Rehabilitation
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama-shi, Wakayama, Japan
TEL
+81-73-447-2300
Homepage URL
ptnaka@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama-shi, Wakayama, Japan
Tel
+81-73-447-2300
wa-rinri@wakayama-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
| 2026 | Year | 04 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational cohort study
Management information
Registered date
| 2026 | Year | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069944
