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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024471
Receipt No. R000028133
Scientific Title A prospective multicenter evaluation for prevalence and distribution of ossified lesion in whole spine of patients with cervical ossification of posterior longitudinal ligament
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/18

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Basic information
Public title A prospective multicenter evaluation for prevalence and distribution of ossified lesion in whole spine of patients with cervical ossification of posterior longitudinal ligament
Acronym A prospective multicenter study for ossified lesion in whole spine of OPLL patients
Scientific Title A prospective multicenter evaluation for prevalence and distribution of ossified lesion in whole spine of patients with cervical ossification of posterior longitudinal ligament
Scientific Title:Acronym A prospective multicenter study for ossified lesion in whole spine of OPLL patients
Region
Japan

Condition
Condition Cervical ossification of posterior longitudinal ligament
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prospectively evaluate the incidence and distribution of ossification of the posterior longitudinal ligament (OPLL) in the whole spine on computed tomography (CT) images in patients who have cervical OPLL on plain X-ray and to analyze factors correlated with multiple lesions.
Basic objectives2 Others
Basic objectives -Others To clarify whether there is any correlation between the degree of ossification and back pain in this study as well.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CT images of the whole spine will be obtained for each patient. Distribution of OPLL, the sum of the levels in which OPLL exists (ossification index of OPLL: OP-index), and the sum of cervical intervertebral segments where ossification of the anterior longitudinal ligament exists (cervical OA-index) will be investigated.
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 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu Kawaguchi
Organization Faculty of Medicine, University of Toyama
Division name Department of Orthopedic Surgery,
Zip code
Address 2630 Sugitani, Toyama, Toyama, 930-0194, Japan
TEL 076-434-2281
Email zenji@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Hirai
Organization Tokyo Medical and Dental University
Division name Department of Orthopedic Surgery
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5279
Homepage URL
Email hirai.orth@tmd.ac.jp

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

Funding Source
Organization The Ministry of Health, Labour and Welfare
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
2016 Year 11 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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 30 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
2016 Year 10 Month 18 Day
Last modified on
2016 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028133

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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