UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025407
Receipt number R000029249
Scientific Title Multicenter Prospective Survey of Perioperative Complications of Spine Surgery in Patients aged 80 Years or Older
Date of disclosure of the study information 2017/01/01
Last modified on 2018/06/15 14:04:27

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Basic information

Public title

Multicenter Prospective Survey of Perioperative Complications of Spine Surgery in Patients aged 80 Years or Older

Acronym

Multicenter Prospective Survey of Perioperative Complications of Spine Surgery in Patients aged 80 Years or Older

Scientific Title

Multicenter Prospective Survey of Perioperative Complications of Spine Surgery in Patients aged 80 Years or Older

Scientific Title:Acronym

Multicenter Prospective Survey of Perioperative Complications of Spine Surgery in Patients aged 80 Years or Older

Region

Japan


Condition

Condition

spine disease

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to assess the perioperative complication rates and risk factors of spine surgery in patients aged 80 years or older

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

perioperative complications and mortality within 30 days postoperatively

Key secondary outcomes

reoperation within 30 days


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

spine surgery

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

80 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients aged 80 years or older who undergo spine surgery for degenerative spine diseases

Key exclusion criteria

patients with pyogenic spondylitis, metastatic bone tumor, spinal trauma or spinal cord injury

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takamasa Watanabe

Organization

Hakodate Central General Hospital

Division name

Spine center

Zip code


Address

33-2, Honcho, Hakodate city, Hokkaido

TEL

0138-52-1231

Email

watanabe-t@hakochu-hp.gr.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takamasa Watanabe

Organization

Hakodate Central General Hospital

Division name

Spine center

Zip code


Address

33-2, Honcho, Hakodate city, Hokkaido

TEL

0138-52-1231

Homepage URL


Email

watanabe-t@hakochu-hp.gr.jp


Sponsor or person

Institute

Hokkaido Spine Study Group

Institute

Department

Personal name



Funding Source

Organization

Hokkaido Spine Study Group

Organization

Division

Category of Funding Organization

Non profit foundation

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

函館中央病院(北海道)、北海道大学病院(北海道)、北海道せき損センター(北海道)、北海道整形外科記念病院(北海道)、えにわ病院(北海道)、市立札幌病院(北海道)、斗南病院(北海道)、釧路ろうさい病院(北海道)


Other administrative information

Date of disclosure of the study information

2017 Year 01 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

Completed

Date of protocol fixation

2016 Year 11 Month 28 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2018 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 26 Day

Last modified on

2018 Year 06 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029249


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name