UMIN-ICDS Clinical Trial

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

Polydactyly of the thumb

Classification by specialty

Orthopedics

Plastic surgery

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Postoperative skeletal malalignment

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

susumus@kuhp.kyoto-u.ac.jp

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/

Email

susumus@kuhp.kyoto-u.ac.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

Japanese Society for Surgery of the Hand

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2024

Year

01

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

12

Month

05

Day

Date of IRB

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

Date trial data considered complete

Date analysis concluded

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

Registered date

2023

Year

12

Month

25

Day

Last modified on

2023

Year

12

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060736