UMIN-CTR Clinical Trial

Public title

Locomotive syndrome; The intervention effect of operation and economic indicator (multicenter prospective observational study)

Acronym

Locomotive syndrome; The intervention effect of operation and economic indicator

Scientific Title

Locomotive syndrome; The intervention effect of operation and economic indicator (multicenter prospective observational study)

Scientific Title:Acronym

Locomotive syndrome; The intervention effect of operation and economic indicator

Region

Japan

Condition

Lumbar spinal canal stenosis
Osteoarthritis of the knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify
-the impact of operations for lumbar decompression and total knee arthroplasty on the locomotive function and the medical economic effect
-influence of the age on the effect

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Questionnaires on physical activity (GLFS-25), QOL questionnaire (EQ-5D-5L), and the data of health insurance claims. Preoperation and 1 year after operation.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

60

years-old

<=

Age-upper limit

89

years-old

>=

Gender

Male and Female

Key inclusion criteria

Lumbar spinal canal stenosis
1) elective decompression without instrumentations
2) patients who we can do one-year follow-up study

Osteoarthritis of the knee
1) elective total knee arthroplasty
2) patients who we can do one-year follow-up study

Key exclusion criteria

1) patients who have severe complications
2) cases of the second surgery
3) patients who have locomotory surgical histories or fracture treatment within a year

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Tanaka, Sakae

Organization

Faculty of Medicine, The University of Tokyo

Division name

Department of Orthopaedic Surgery

Zip code

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.

TEL

03-3815-5411

Email

tanakas-ort@h.u-tokyo.ac.jp

Name of contact person

1st name
Middle name
Last name	Chikuda, Hirotaka

Organization

Faculty of Medicine, The University of Tokyo

Division name

Department of Orthopaedic Surgery

Zip code

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.

TEL

03-3815-5411

Homepage URL

Email

chikuda-tky@umin.ac.jp

Institute

Faculty of Medicine, The University of Tokyo

Institute

Department

Personal name

Organization

The Japanese Orthopaedic Association

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

National Rehabilitation Center for Persons with Disabilities
Department of Health Care Economics and Industrial Policy, Osaka University Graduate School of Medicine
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Ehime
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Hirosaki
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Kyoto
Department of Orthopedic Biomaterial Science, Osaka University Graduate School of Medicine
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Kyusyu
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Toyama
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Akita
Department of Orthopaedic Surgery, Tokyo Medical and Dental University
Department of Orthopaedic Surgery, Japanese Red Cross Medical Center

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

08

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2016

Year

05

Month

31

Day

Date of IRB

Anticipated trial start date

2016

Year

09

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is aiming to reveal the effectiveness of operative intervention to lumbar canal stenosis and osteoarthritis of the knee, major diseases of locomotive syndrome. Health economical assessment will be also performed.

Registered date

2016

Year

08

Month

11

Day

Last modified on

2018

Year

11

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027152