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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029827
Receipt No. R000024851
Scientific Title Comparative study between Japan and US for actual using state of prosthetic arm
Date of disclosure of the study information 2018/01/14
Last modified on 2019/05/08

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Basic information
Public title Comparative study between Japan and US for actual using state of prosthetic arm
Acronym actual using state of prosthetic arm
Scientific Title Comparative study between Japan and US for actual using state of prosthetic arm
Scientific Title:Acronym actual using state of prosthetic arm
Region
Japan North America

Condition
Condition upper arm amputatee
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to correct the data about patients with upper arm amputation in US and Japan
to understand the needs of upper limb amputee and put developing a new artificial limb to use
Basic objectives2 Others
Basic objectives -Others study of epidemics
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the big data about prosthetic usage in US and Japan
Key secondary outcomes QOL and ADL of the patients with upper arm amputation

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
75 years-old >=
Gender Male and Female
Key inclusion criteria upper limb amputation patients who have made prosthetic arm
Key exclusion criteria those who cann't speak Japanese or English
Target sample size 450

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Hirata
Organization Nagoya University Graduate School of Medicine
Division name Hand surgery
Zip code 466
Address 65 Tsurumai-cho Showa-ku, Nagoya
TEL 052-744-2957
Email h-hirata@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Michiro
Middle name
Last name Yamamoto
Organization Nagoya University Graduate School of Medicine
Division name Hand surgery
Zip code 466-8550
Address 65 tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2957
Homepage URL
Email michi-ya@med.nagoya-u.ac.jp

Sponsor
Institute Department of Hand Surgery, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 Nagoya University Graduate School of Medicine
Address 65 Tsurumai-cho, Showa-ku, Nagoya
Tel 0527412111
Email ethics@med.nagoya-u.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 01 Month 14 Day

Related information
URL releasing protocol in press at Plastic and Reconstructeve Surgery Gloval Open
Publication of results Published

Result
URL related to results and publications in press at Plastic and Reconstructeve Surgery Gloval Open
Number of participants that the trial has enrolled 174
Results
Among 398 patients invited, 174 patients with upper limb loss participated in this study. The most common amputation level was trans-radial. Trauma was the most common cause of limb loss. The prosthesis rejection rate was 9% (n=16). The most common reason for abandonment was prosthesis functionality . The mean EQ-5D utility score of prosthesis users was significantly higher than that of nonusers (p<0.01). 
Results date posted
2019 Year 05 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The purpose of this international, cross-sectional, multicenter study was to examine prosthesis use and abandonment among patients with upper limb deficiencies in the USA and Japan. We determined the most common reasons for abandonment and compared prosthesis users and nonusers according to a variety of demographic and clinical characteristics. We hypothesized that prosthesis users would have higher QOL than nonusers, and that patients who used myoelectric prostheses were more likely to be employed full-time. We also compared EQ-5D scores between patients and live-in proxies to determine the agreement in QOL between patients and their close relationships, hypothesizing that patient-reported QOL would be superior to proxy-reported values.
Participant flow
Three rehabilitation centers in Japan and one academic medical center in the USA participated. Patients aged between 12 and 75 years with unilateral or bilateral upper limb absence from the level of wrist to shoulder disarticulation were included. Two questionnaires, an original questionnaire on prosthesis use and the EQ-5D. The questionnaires were completed by both the patient and a live-in proxy on the patients behalf. 
Adverse events
none
Outcome measures
QOL and abandonment rate of the prosthesis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 03 Month 18 Day
Date of IRB
2016 Year 03 Month 18 Day
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We sent questionairs after uniformed protocol was made in Japan and US.

Management information
Registered date
2017 Year 11 Month 05 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024851

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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