UMIN-CTR Clinical Trial

Basic information
Public title	Multi-center randomized controlled blind study of LC-4308 in Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed
Acronym	Multi-center randomized controlled blind study of LC-4308
Scientific Title	Multi-center randomized controlled blind study of LC-4308 in Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed
Scientific Title:Acronym	Multi-center randomized controlled blind study of LC-4308
Region	Japan

Condition
Condition	Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate Safety and Efficacy of LC-4308 compared with Standard of care group for Distal Radius Fracture patients treated with Volar Locking Plate scheduled to be removed
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adhesion at locking plate removal
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	LC-4308 (Adhesion Barrier System)
Interventions/Control_2	Standard of care
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	(1)Patients provided written informed consent (2)Patients aged 20 years or older at the time of informed consent (3)Patients who are diagnosed A2, A3, C1 or C2 by AO classification (4)Patients who are able to keep splint for 1 week (5)Patients who are scheduled to be removed locking plate (6)Patients who are able to be tested according to the plan (7)Patients who have surgery within 2 weeks after injury
Key exclusion criteria	(1)Patients with an open fracture in the target site (2)Patients complicated by other site fractures which may influence the evaluation of end points (3)Patients with the possibility of the rupture of tendon, main nerve, or blood vessels in the target site (4)Patients with the possibility of the combination of Artificial bones (5)Patients with the possibility of the placement of the locking plate beyond the watershed line (6)Patients unable to follow the instruction of rehabilitation (7)Patients who have limited range of motion of either one or both thumbs (8)Patients with high risk of fracture from the continuous treatment of oral steroids (9)Patients with serious Cardiovascular diseases, Liver diseases, Respiratory diseases, Malignancy or Immunodeficiency at registration (10)Patients with a history of severe drug allergies (11)Patients with a history of Biodegradable plastic allergies (12)Uncontrollable Diabetes mellitus (13)Patients with pregnancy or possible pregnancy, patients who are breast-feeding, and patients who cannot prevent pregnancy properly until locking plate removal after informed consent (14)Patients with Rheumatoid arthritis (15)Patients who are continuing to undergo or have not yet finished their tests or other clinical studies under informed consent (16)Others, patients who are judged as inadequately by principal investigator or sub-investigator
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhiko Matsushita
Organization	Kawasaki Municipal Tama Hospital
Division name	Orthopedics
Zip code
Address	1-30-37 Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa-ken
TEL	044-933-8111
Email	k2matsu@marianna-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shinji Namoto
Organization	JMS CO.,LTD.
Division name	Clinical Research Section Regulatory Affairs and Quality Assurance Division
Zip code
Address	12-17 Kako-machi, Naka-ku, Hiroshima-shi, Hiroshima-ken
TEL	082-243-6033
Homepage URL
Email	s-namoto@jms.cc

Sponsor
Institute	JMS CO.,LTD.
Institute
Department

Funding Source
Organization	JMS CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 04 Month 17 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
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	2017 Year 08 Month 31 Day
Date of IRB	2017 Year 11 Month 30 Day
Anticipated trial start date	2017 Year 12 Month 08 Day
Last follow-up date	2018 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 17 Day
Last modified on	2019 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036812