UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Surgical Treatment for Distal Clavicle Fracture
Title of the study (Brief title)	Surgical Treatment for Distal Clavicle Fracture
Region	Japan

Condition
Condition	Distal clavicle fracture
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare with ligament reconstruction and plate fixation in the surgical treatment of the distal clavicle fracture
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bony healing on X-ray, ROM, DASH score
Key secondary outcomes

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	Maneuver
Interventions/Control_1	ligament reconstruction
Interventions/Control_2	plate fixation
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	distal clavicle fracture indication for ORIF
Key exclusion criteria	previous surgery or dysfunction in the affected side
Target sample size	30

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

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 12 Month 23 Day
Anticipated trial start date	2011 Year 12 Month 23 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 31 Day
Last modified on	2017 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016450