UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035194
Receipt number 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 2023/12/17 10:54:43

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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 Toshitaka
Middle name
Last name Yoshii

Organization

Tokyo Medical and Dental University

Division name

Department of Orthopedic Surgery

Zip code

113-8510

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 Toshitaka
Middle name
Last name Yoshii

Organization

Tokyo Medical and Dental University

Division name

Department of Orthopedic Surgery

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-4279

Homepage URL


Email

opll.orth@tmd.ac.jp


Sponsor or person

Institute

Japanese organization of the Study for Ossification of Spain Ligament

Institute

Department

Personal name



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

Tokyo Medical and Dental University

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

Tel

03-5803-4730

Email

info.bec@tmd.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

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

680

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

No longer recruiting

Date of protocol fixation

2018 Year 11 Month 28 Day

Date of IRB

2019 Year 04 Month 23 Day

Anticipated trial start date

2019 Year 04 Month 23 Day

Last follow-up date

2031 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2034 Year 03 Month 31 Day


Other

Other related information

Update will be made near future


Management information

Registered date

2018 Year 12 Month 10 Day

Last modified on

2023 Year 12 Month 17 Day



Link to view the page

Value
https://center6.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