UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015904 |
|---|---|
| Receipt number | R000018511 |
| 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 |
| Date of disclosure of the study information | 2014/12/10 |
| Last modified on | 2020/06/16 10:50:04 |
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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
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
asami.taguchi@medtronic.com
Sponsor or person
Institute
Medtronic Sofamor Danek, Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018511
