UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014123 |
|---|---|
| Receipt number | R000016442 |
| Scientific Title | 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 18:44:44 |
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Basic information
Public title
Risk assessment of subcutaneous tendon rupture following plate fixation of distal radius fractures
Acronym
Risk assessment of subcutaneous tendon rupture following plate fixation of distal radius fractures
Scientific Title
Risk assessment of subcutaneous tendon rupture following plate fixation of distal radius fractures
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamazaki |
Organization
Aizawa Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-5-2 Honjo, Matsumoto
TEL
0263-33-8600
hiroshiymzk1017@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamazaki |
Organization
Aizawa Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-5-2 Honjo, Matsumoto
TEL
0263-33-8600
Homepage URL
seke-dr5@ai-hosp.or.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016442
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
