UMIN-CTR Clinical Trial

Basic information
Public title	The study of three dimensional corrective surgery with patient matched surgical instruments.
Acronym	The study of three dimensional corrective surgery.
Scientific Title	The study of three dimensional corrective surgery with patient matched surgical instruments.
Scientific Title:Acronym	The study of three dimensional corrective surgery.
Region	Japan

Condition
Condition	limb bones and bony skeleton with deformity
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the corrective osteotomy for the bone deformities, conventional preoperative planning with two-dimensional plain radiographs has not always provided sufficient information to understand the complex three-dimensional deformity. Surgeons has estimated the amount of reduction and manually corrected in the actual surgery. We have developed 3D computer simulations and a custom-made surgical guide to perform accurate corrective osteotomy. The custom-made surgical guide was obtained the regulatory approval in the distal humerus and the distal radius. The purpose of this study is to examine the surgical guide applying to limb bones and bony skeleton.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The efficiency and availability of the surgical guide are evaluated to compare the preoperative simulation and the postoperative results by measuring the deformity with the X ray.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Surgery for deformity correction of limb bones and bony skeleton using custom-made surgical guide based on preoperative computer simulation with CT data
Interventions/Control_2
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	6 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Deformity of the upper extremity (malunited fracture, early closure of the growth plate, congenital anomaly)
Key exclusion criteria	1. Sever shortening of the bone that cannot be corrected at one time. 2. Inappropriate candidate for general anesthesia. 3. Patient who is pregnant or possibly pregnant. Patient who hope to be pregnant during her trial. 4. Patient who has mental disorder and can not understand the significance of the study and preserve the compliance rules. 5. Patient who is administrated anticoagulant that cannot be interrupted for the operation
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kunihiro Middle name Last name Oka
Organization	Osaka University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Zip code	565-0871
Address	2-2, Yamada-Oka, Suita, Osaka
TEL	06-6879-3552
Email	oka-kunihiro@umin.ac.jp

Public contact
Name of contact person	1st name Kunihiro Middle name Last name Oka
Organization	Osaka University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Zip code	565-0871
Address	2-2, Yamada-Oka, Suita, Osaka
TEL	06-6879-3552
Homepage URL
Email	oka-kunihiro@umin.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board of Osaka University Hospital
Address	2-2 Yamadaoka Suita Osaka
Tel	06-6210-8290
Email	rinri@hp-crc.med.osaka-u.ac.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

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 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	2014 Year 08 Month 29 Day
Date of IRB	2014 Year 08 Month 29 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2020 Year 03 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	2015 Year 09 Month 29 Day
Last modified on	2020 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022139