UMIN-CTR Clinical Trial

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
Email	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
Email	nishiwa@jd5.so-net.ne.jp

Sponsor
Institute	Kawasaki Municipal Kawasaki Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045513