UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039922 |
|---|---|
| Receipt number | R000045513 |
| Scientific Title | A Prospective Randomized Comparison of Variable-Angle and Fixed-Angle Volar Locking Plating for Intra-articular Distal Radial Fractures |
| Date of disclosure of the study information | 2020/03/24 |
| Last modified on | 2020/03/24 19:20:34 |
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Basic information
Public title
A Prospective Randomized Comparison of Variable-Angle and Fixed-Angle Volar Locking Plating for Intra-articular Distal Radial Fractures
Acronym
A Prospective Randomized Comparison of Variable-Angle and Fixed-Angle Volar Locking Plating for Intra-articular Distal Radial Fractures
Scientific Title
A Prospective Randomized Comparison of Variable-Angle and Fixed-Angle Volar Locking Plating for Intra-articular Distal Radial Fractures
Scientific Title:Acronym
AA Prospective Randomized Comparison of Variable-Angle and Fixed-Angle Volar Locking Plating for Intra-articular Distal Radial Fractures
Region
| Japan |
Condition
Condition
Distal Radial Fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospectively compare functional and radiographic outcomes of variable-angle volar locking plates with fixed-angle volar locking plates for the treatment of intra-articular fractures of the distal radius
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PRWE score
Key secondary outcomes
DASH score, range of wrist motion (extension, flexion, radial deviation, ulnar deviation, pronation, supination), grip power, complicaion, radiographic parameters (radial inclination, volar tilt, radial height, ulnar variance), CT (articular gap, step-off, plate position)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Device,equipment | Other |
Interventions/Control_1
fixed-angle locking plate
Interventions/Control_2
variable-angle locking plate
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients older than 18 years with unstable intra-articular distal radial fracture
Key exclusion criteria
extra-articular fracture, bilateral fracture, open fracture, pre-existing arthritis of the wrist or hand, prior traumatic injury to the wrist or hand, concomitant ipsilateral upper-extremity injury other than a fracture of the ulnar styloid, more than two weeks after the injury
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | MASAO |
| Middle name | |
| Last name | NISHIWAKI |
Organization
Kawasaki Municipal Kawasaki Hospital
Division name
Hand and Elbow Surgery Center
Zip code
2100013
Address
12-1, Shinkawadori, Kawasaki-ku, Kawasaki
TEL
0442335521
nishiwa@jd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | MASAO |
| Middle name | |
| Last name | NISHIWAKI |
Organization
Kawasaki Municipal Kawasaki Hospital
Division name
Hand and Elbow Surgery Center
Zip code
2100013
Address
12-1, Shinkawadori, Kawasaki-ku, Kawasaki
TEL
0442335521
Homepage URL
nishiwa@jd5.so-net.ne.jp
Sponsor or person
Institute
Kawasaki Municipal Kawasaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funded
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
Ethics Borard, Kawasaki Municipal Kawasaki Hospital
Address
12-1, Shinkawadori, Kawasaki-ku, Kawasaki
Tel
0442335521
kmh121@feel.ocn.ne.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
川崎市立川崎病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
120
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
| 2014 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 24 | Day |
Last modified on
| 2020 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045513
