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Recruitment status Completed
Unique ID issued by UMIN UMIN000015178
Receipt No. R000017631
Official scientific title of the study development for impingement analysis of elbow and forearm deformity
Date of disclosure of the study information 2014/09/16
Last modified on 2017/10/07

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Basic information
Official scientific title of the study development for impingement analysis of elbow and forearm deformity
Title of the study (Brief title) development for impingement analysis
Region
Japan

Condition
Condition elbow osteoarthritis
forearm deformity
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to simulate the impingement area for surgery og elbow osteoarthritis and forearm deformity
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes range of motion after surgery
Key secondary outcomes patient-rated outcome measure Hand20

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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
Device,equipment Maneuver
Interventions/Control_1 operative treatment after simulation
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
12 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria patients with elbow osteoarthritis and forearm deformity
Key exclusion criteria patients who disagree with simulation
Target sample size 20

Research contact person
Name of lead principal investigator Hitoshi Hirata
Organization Nagoya University
Division name Hand surgery
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 Michiro Yamamoto
Organization Nagoya University
Division name Hand surgery
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
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2014 Year 09 Month 16 Day

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 02 Month 14 Day
Anticipated trial start date
2012 Year 02 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 09 Month 16 Day
Last modified on
2017 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017631


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