UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032683 |
|---|---|
| Receipt number | R000037269 |
| Scientific Title | Efficacy of additional multiple tenotomy in the Ponseti method for manipulation-resistant congenital talipes equinovarus |
| Date of disclosure of the study information | 2018/05/23 |
| Last modified on | 2018/05/23 11:05:35 |
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Basic information
Public title
Efficacy of additional multiple tenotomy in the Ponseti method for manipulation-resistant congenital talipes equinovarus
Acronym
Efficacy of multiple tenotomy for congenital talipes equinovarus
Scientific Title
Efficacy of additional multiple tenotomy in the Ponseti method for manipulation-resistant congenital talipes equinovarus
Scientific Title:Acronym
Efficacy of multiple tenotomy for congenital talipes equinovarus
Region
| Japan |
Condition
Condition
congenital talipes equinovarus
Classification by specialty
| Orthopedics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this clinical study is to compare efficacy of additional multiple tenotomy and single heel-cord tenotomy in the Ponseti method for infants with manipulation-resistant congenital talipes equinovarus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plantigrade walking 24 months after multiple tenotomy
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Multiple tenotomy following serial manipulation and corrective cast
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
| 3 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who demonstrate ninety degrees or more of tibiocalcaneal angle or twenty degrees or less of talocalcaneal angle on the maximum dorsiflexion lateral radiograph of the foot made immediately after serial manipulation and corrective cast
Key exclusion criteria
Patients who are treated for congenital talipes equinovarus elsewhere prior to presentation at our institution
Patients who present with congenital talipes equinovarus at three months or more after birth
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kitoh |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-741-2111
hkitoh@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Mishima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-741-2111
Homepage URL
m-kenichi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 05 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 23 | Day |
Last modified on
| 2018 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037269
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
