UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014052 |
|---|---|
| Receipt number | R000016362 |
| Scientific Title | Is arthroscopy advantageous over fluoroscopy for articular reduction of intra-articular distal radius fractures treated with volar locking plate fixation? - a randomized controlled trial |
| Date of disclosure of the study information | 2014/05/23 |
| Last modified on | 2015/05/30 18:45:53 |
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Basic information
Public title
Is arthroscopy advantageous over fluoroscopy for articular reduction of intra-articular distal radius fractures treated with volar locking plate fixation? - a randomized controlled trial
Acronym
Is arthroscopy advantageous over fluoroscopy for articular reduction of intra-articular distal radius fractures treated with volar locking plate fixation? - a randomized controlled trial
Scientific Title
Is arthroscopy advantageous over fluoroscopy for articular reduction of intra-articular distal radius fractures treated with volar locking plate fixation? - a randomized controlled trial
Scientific Title:Acronym
Is arthroscopy advantageous over fluoroscopy for articular reduction of intra-articular distal radius fractures treated with volar locking plate fixation? - a randomized controlled trial
Region
| Japan |
Condition
Condition
distal radius fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compares radiographic and clinical outcomes of the arthroscopically and fluoroscopically assisted reduction techniques for treatment of intra-articular distal radius fractures combined with volar locking plate fixation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
range of motion of the wrist
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
arthroscopic reduction
Interventions/Control_2
fluoroscopic reduction
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Unacceptable intra-articular fracture with any intra-articular step or gap deformity of 2 mm or more
Key exclusion criteria
patients under the age of 20 years; patients with pathological fractures; patients with bilateral distal radius fractures; more than 14 days between injury and surgery; isolated radial styloid or volar Barton fracture; associated ulnar fracture apart from ulnar styloid fracture
Target sample size
74
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, Japan 390-8510
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, Japan 390-8510
TEL
0263-33-8600
Homepage URL
hiroshiymzk1017@ybb.ne.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 23 | 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
| 2009 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 22 | 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 | 23 | 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=R000016362
