UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035194
Receipt No. R000039771
Scientific Title Construction of registry of patients with ossification of posterior longitudinal ligament: A prospective multi-center study
Date of disclosure of the study information 2018/12/30
Last modified on 2018/12/10

* 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 Construction of registry of patients with ossification of posterior longitudinal ligament: A prospective multi-center study
Acronym Construction of registry of patients with ossification of posterior longitudinal ligament
Scientific Title Construction of registry of patients with ossification of posterior longitudinal ligament: A prospective multi-center study
Scientific Title:Acronym Construction of registry of patients with ossification of posterior longitudinal ligament
Region
Japan

Condition
Condition OPLL
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to create a registry of patients with ossification of posterior longitudinal ligament (OPLL) and to manage preservation treatment cases and surgical treatment cases over the medium to long term.
Basic objectives2 Others
Basic objectives -Others To clarify the natural history of OPLL, the results of conservative treatment, the severity risk factor, the long-term performance of surgical treatment, and the recurrence rate by create the OPLL registry.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes First time registration: Early onset date, diagnosed date, family history, past history, smoking / drunk habit, medication history, JOA score, EQ-5D-5L, NDI, VAS, Xp, CT
At follow-up: outcome, new medication history, JOA score, EQ-5D-5L, NDI, VAS, Xp, presence of surgery
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients in whom ossification of posterior longitudinal ligament is confirmed on plain X-ray
Key exclusion criteria Patients will not get consent
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshitaka Yoshii
Organization Tokyo Medical and Dental University
Division name Department of Orthopedic Surgery
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-4279
Email yoshii.orth@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshitaka Yoshii
Organization Tokyo Medical and Dental University
Division name Department of Orthopedic Surgery
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-4279
Homepage URL
Email yoshii.orth@tmd.ac.jp

Sponsor
Institute Japanese organization of the Study for Ossification of Spain Ligament
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 12 Month 30 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
2018 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Update will be made near future

Management information
Registered date
2018 Year 12 Month 10 Day
Last modified on
2018 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039771

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.