UMIN-CTR Clinical Trial

Basic information
Public title	A prospective, multicenter clinical study of the MDT-4113 for the treatment of patients with Severe, Progressive, Life-threatening Early Onset Pediatric Scoliosis:EOS
Acronym	A prospective, multicenter clinical study of the MDT-4113 for the treatment of patients with Severe, Progressive, Life-threatening Early Onset Pediatric Scoliosis:EOS
Scientific Title	A prospective, multicenter clinical study of the MDT-4113 for the treatment of patients with Severe, Progressive, Life-threatening Early Onset Pediatric Scoliosis:EOS
Scientific Title:Acronym	A prospective, multicenter clinical study of the MDT-4113 for the treatment of patients with Severe, Progressive, Life-threatening Early Onset Pediatric Scoliosis:EOS
Region	Japan

Condition
Condition	Early Onset Pediatric Scoliosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To Evaluate clinical safety and probable benefit of the investigational device system, MDT-4113, when the system is used for patients with severe, progressive, and life-threatening Early Onset Scoliosis associated with thoracic insufficiency syndrome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Success is defined as a postoperative 24 months major curve Cobb angle less than or equal to 50+/-5 degrees or an improvement of at least 50% compared to preoperative. (+/-5 is error of measurement)
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	Implantation of MDT-4113 From operation for MDT-4113 implantation to postoperative 24 months or final fusion operation
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	Not applicable
Age-upper limit	10 years-old >
Gender	Male and Female
Key inclusion criteria	1. Diagnosed to severe, progressive, life-threatening Early Onset Scoliosis including congenital scoliosis, juvenile scoliosis, neuromuscular scoliosis and syndromic scoliosis 2. Preoperative major curve Cobb Angle >50 +/-5 degrees (+/-5 degrees is error of measurement) 3. Spinal Curve length over at least 6 segments of the spine 4. Is less than 10 years of age at the time of the index surgery 5. His/her parent or legal guardian has signed the Informed Consent form
Key exclusion criteria	1. Has active infection and/or has significant infectious risk 2. Is diagnosed to allergy or hypersensitivity to metal or is suspect to metal allergy/hypersensitivity 3. General anesthesia is NOT appropriate 4. Operated on spinal fusion with implant(s) 5. Had participated other clinical trial during the last 3 months 6. Has convulsion (If an investigator decides that a patient is not appropriate to enter this study) 7. Has untreated syringomyelia, spinal deformity or spinal cord tumor 8. Reaches skeletal maturity 9. Has inadequate tissue coverage over the operative site 10. Has hypophrenia (If an investigator decides that a patient is not appropriate to enter this study.) 11. Has rib fusion 12. His/her parent or legal guardian has not signed the Informed Consent form
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Asami Middle name Last name Taguchi
Organization	Medtronic Sofamor Danek, Co., Ltd.
Division name	Regulatory and Clinical Affairs
Zip code	108-0075
Address	Shinagawa Season Terrace 1-2-70 Konan, Minato-ku, Tokyo
TEL	03-6776-0018
Email	asami.taguchi@medtronic.com

Public contact
Name of contact person	1st name Asami Middle name Last name Taguchi
Organization	Medtronic Sofamor Danek, Co., Ltd.
Division name	Regulatory and Clinical Affairs
Zip code	108-0075
Address	Shinagawa Season Terrace 1-2-70 Konan, Minato-ku, Tokyo
TEL	03-6776-0352
Homepage URL
Email	asami.taguchi@medtronic.com

Sponsor
Institute	Medtronic Sofamor Danek, Co., Ltd.
Institute
Department

Funding Source
Organization	Medtronic Sofamor Danek, 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	Medtronic Sofamor Danek,Co.,Ltd.
Address	Shinagawa Season Terrace, 1-2-70, Konan, Minato-ku, Tokyo
Tel	03-6776-0018
Email	asami.taguchi@medtronic.com

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 12 Month 10 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	No longer recruiting
Date of protocol fixation	2014 Year 03 Month 31 Day
Date of IRB	2014 Year 07 Month 15 Day
Anticipated trial start date	2014 Year 09 Month 05 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 12 Month 10 Day
Last modified on	2020 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018511