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Recruitment status Completed
Unique ID issued by UMIN UMIN000014123
Receipt No. R000016442
Official scientific title of the study Risk assessment of subcutaneous tendon rupture following plate fixation of distal radius fractures
Date of disclosure of the study information 2014/05/30
Last modified on 2015/05/30

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Basic information
Official scientific title of the study Risk assessment of subcutaneous tendon rupture following plate fixation of distal radius fractures
Title of the study (Brief title) Risk assessment of subcutaneous tendon rupture following plate fixation of distal radius fractures
Region
Japan

Condition
Condition distal radius fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purposes of thit study were to identify the frequency of tendon attrition after the treatment of radius fractures with volar locking plate and to define independent predictors of tendon attrition. Our hypothesis was that crepitus with FPL tendon motion would be important predictors as well as the plate position.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes tendon attrition
Key secondary outcomes

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

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Crepitus around the wrist with an active thumb motion are examined.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who were treated at our institute with plate removal following volar plating of distal radius fractures.
Key exclusion criteria The patients underwent removal of hardware for tenosynovitis, tendon rupture, or hardware malposition.
Target sample size 100

Research contact person
Name of lead principal investigator Hiroshi Yamazaki
Organization Aizawa Hospital
Division name Department of Orthopaedic Surgery
Address 1-5-2 Honjo, Matsumoto
TEL 0263-33-8600
Email hiroshiymzk1017@ybb.ne.jp

Public contact
Name of contact person Hiroshi Yamazaki
Organization Aizawa Hospital
Division name Department of Orthopaedic Surgery
Address 1-5-2 Honjo, Matsumoto
TEL 0263-33-8600
Homepage URL
Email seke-dr5@ai-hosp.or.jp

Sponsor
Institute Aizawa Hospital
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 Shinshu Public Utility Foundation for Promotion of Medical Sciences
Japan Orthopaedics and Traumatology Foundation
Japanese Society for Surgery of the Hand
Organization
Division
Category of Funding Organization Non profit foundation
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 05 Month 30 Day

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 08 Month 30 Day
Anticipated trial start date
2012 Year 08 Month 30 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 Published
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 05 Month 30 Day
Last modified on
2015 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016442


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