UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027479
Receipt number R000031374
Scientific Title Impact of Adjacent Ankylosing Spinal Disorders on the Prognosis of Osteoporotic Vertebral Fractures: A multicenter prospective cohort study
Date of disclosure of the study information 2017/05/29
Last modified on 2023/05/30 14:28:02

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Basic information

Public title

Impact of Adjacent Ankylosing Spinal Disorders on the Prognosis of Osteoporotic Vertebral Fractures: A multicenter prospective cohort study

Acronym

Impact of Adjacent Ankylosing Spinal Disorders on the Prognosis of Osteoporotic Vertebral Fractures: A multicenter prospective cohort study

Scientific Title

Impact of Adjacent Ankylosing Spinal Disorders on the Prognosis of Osteoporotic Vertebral Fractures: A multicenter prospective cohort study

Scientific Title:Acronym

Impact of Adjacent Ankylosing Spinal Disorders on the Prognosis of Osteoporotic Vertebral Fractures: A multicenter prospective cohort study

Region

Japan


Condition

Condition

Osteoporotic Vertebral Fracture

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the risk of occurrence of pseudo-arthrosis due to ankyloses in the adjacent level to the osteoporotic vertebral fracture based on accurate diagnosis and prognostic evaluation.

Basic objectives2

Others

Basic objectives -Others

Pain, neurologic symptoms, back pain assessment method will be described.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The risk of pseudo-arthrosis in the 6 months after the onset.

Key secondary outcomes

Operation
Verbal Descriptor Scale of pain
Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ)
American Spinal Injury Association Impairment Scale


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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who had a posterior wall injury due to a fresh osteoporotic vertebral body fracture in the 11th thoracic vertebra to 5th lumbar vertebra.

Key exclusion criteria

Patients who can not make appropriate assessment.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name ITOI

Organization

Juntendo University Shizuoka Hospital

Division name

orthopadic surgery

Zip code

410-2295

Address

Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan

TEL

0559483111

Email

aitoi@juntendo.ac.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name ITOI

Organization

Juntendo University Shizuoka Hospital

Division name

orthopadic surgery

Zip code

4102295

Address

Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan

TEL

0559483111

Homepage URL


Email

aitoi@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University Shizuoka Hospital orthopadic surgery

Institute

Department

Personal name



Funding Source

Organization

Juntendo university Juntendo hospital orthopedic surgery

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

Department of Orthopaedic Surgery., Juntendo University. Shizuoka Hospital

Address

Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan

Tel

0559483111

Email

aitoi@juntendo.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

2017 Year 05 Month 29 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

Completed

Date of protocol fixation

2017 Year 03 Month 21 Day

Date of IRB

2017 Year 04 Month 10 Day

Anticipated trial start date

2017 Year 05 Month 08 Day

Last follow-up date

2020 Year 05 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing in particular


Management information

Registered date

2017 Year 05 Month 24 Day

Last modified on

2023 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031374


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name