UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053218 |
|---|---|
| Receipt number | R000060736 |
| Scientific Title | A retrospective study of surgical outcomes of thumb polydactyly based on the duplication range classification |
| Date of disclosure of the study information | 2024/01/06 |
| Last modified on | 2025/01/24 18:33:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A clinical study of surgical results of thumb polydactyly based on a new classification
Acronym
A clinical study of thumb polydactyly
Scientific Title
A retrospective study of surgical outcomes of thumb polydactyly based on the duplication range classification
Scientific Title:Acronym
A clinical study of thumb polydactyly using the duplication range classification
Region
| Japan |
Condition
Condition
Polydactyly of the thumb
Classification by specialty
| Orthopedics | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between surgical options of thumb polydactyly and postoperative skeletal malalignment based on the duplication range classification
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative skeletal malalignment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. With preoperative X-rays at 0-1 years of age
2. Who underwent their first surgery before the age of 3
3. With follow-up for 3 years or more after surgery
4. With anteroposterior X-rays of the thumb taken postoperative 1 year and 3 years after surgery, by which joint deviation angles of the MP joint and IP joint can be measured.
Key exclusion criteria
1. Insufficient X-rays
2. Unclear surgical records
3. Judged by the principal investigator to be unsuitable for this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Saito |
Organization
Graduate School of Medicine and Faculty of Medicine, Kyoto University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
606-8507
Address
54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3613
susumus@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Saito |
Organization
Graduate School of Medicine and Faculty of Medicine, Kyoto University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
606-8507
Address
54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3613
Homepage URL
https://keisei.kuhp.kyoto-u.ac.jp/research/basic_clinical/
susumus@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Surgery of the Hand
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
京都大学大学院医学研究科,国立研究開発法人国立成育医療研究センター,日本赤十字社愛知医療センター名古屋第一病院,山形大学医学部附属病院,独立行政法人国立病院機構仙台医療センター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 06 | 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
| 2023 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
1. primary outcome measure
relationship between reconstructive procedures (abductor pollicis muscle transfer, tendon centralization, tendon sheath reconstruction, corrective osteotomy, ligament repair) and postoperative skeletal malalignment (deviation angle of MP and IP joint)
2. secondary outcome measure
relationship between postoperative years and postoperative skeletal malalignment
3. analysis
(1) stratification
･sample stratification using the duplication range concept
(2) design
･a case-control study
(3) variables
･postoperative joint deviation as the case and no joint deviation as the control
･the side of the affected thumb, gender, and reconstructive procedures (abductor pollicis muscle transfer, tendon centralization, tendon sheath reconstruction, corrective osteotomy, ligament repair) are used as explanatory variables.
(4) statistics
･the t-test and Mann Whitney u test depending on the normality of continuous data, the fisher accuracy test for categorical data, and the logistic multivariate analysis for the odds ratio of explanatory variables. descriptive statistics are used for those with a small number of samples.
(5) analysis for secondary outcome measure
Comparison between joint deviation angle 1 year and 3-5 years after surgery
Management information
Registered date
| 2023 | Year | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060736
