UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029827 |
|---|---|
| Receipt number | 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 15:57:28 |
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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
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
michi-ya@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Hand Surgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024851
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