UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058853 |
|---|---|
| Receipt number | R000067301 |
| Scientific Title | Lipid and protein dynamics and ossification mechanisms in ossification of the posterior longitudinal ligament (OPLL) |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/21 00:41:33 |
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Basic information
Public title
Study on lipid and protein dynamics and ossification mechanisms in OPLL
Acronym
OPLLLP (Lipid/Protein) Study
Scientific Title
Lipid and protein dynamics and ossification mechanisms in ossification of the posterior longitudinal ligament (OPLL)
Scientific Title:Acronym
OPLLLP (Lipid/Protein) Study
Region
| Japan |
Condition
Condition
ossification of posterior longitudinal ligament
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the relationship between lipid and protein dynamics within ligament tissue and the mechanisms of ossification in ossification of the posterior longitudinal ligament (OPLL).
Basic objectives2
Others
Basic objectives -Others
Clarification of pathophysiology (mechanisms of disease)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify the relationship between lipid and protein dynamics within ligament tissue and the mechanisms of ossification in ossification of the posterior longitudinal ligament (OPLL).
Key secondary outcomes
To integrate radiologic findings (CT/MRI), serum lipid/adipokine markers, and exploratory genomic analyses to comprehensively evaluate the pathophysiological mechanisms underlying OPLL progression.
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
| 15 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20to90 years with thoracic or cervical OPLL scheduled for surgery
Control group: nonOPLL patients aged 15to40 years scheduled for spinal surgery
Written informed consent obtained from the patient or legally authorized representative
Key exclusion criteria
1. Patients judged inappropriate by the attending physician
2. Patients who did not provide consent for this study
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Ogi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL
053-435-2111
41246237@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Ogi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL
053-435-2111
Homepage URL
41246237@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Research Ethics Committee for Life Science and Medical Research, Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192, Japan Research Promotion Division, Hamamatsu University School of Medicine
Tel
053-435-2111
41246237@hama-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
| 2025 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study.
Exposure: Metabolic abnormalities such as visceral adiposity, oxidized LDL, and local expression of lipid-related molecules
Outcome: Progression of ligament ossification, changes in lipid/protein dynamics within ligament tissue, imaging findings (CT/MRI), serum markers, histological evaluation, and exploratory genomic analyses
Prospective/Retrospective: Prospective
Sampling method: Consecutive case enrollment at multiple institutions, with group comparisons (OPLL vs non-OPLL, including case-control analysis)
Management information
Registered date
| 2025 | Year | 08 | Month | 21 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067301
