UMIN-ICDS Clinical Trial

Public title

Dynamics of superficial and deep fibular nerves during ankle traction

Acronym

Dynamics of superficial and deep fibular nerves during ankle traction

Scientific Title

Dynamics of superficial and deep fibular nerves during ankle traction

Scientific Title:Acronym

Dynamics of superficial and deep fibular nerves during ankle traction

Region

Japan

Condition

Patients undergoing foot/ankle surgery after March 2023 at Chiba University Hospital

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the dynamics of the superficial and deep fibular nerves before and after traction in patients undergoing foot/ankle surgery after spinal or general anesthesia using ultrasound. That is.
Through this study, it is possible to know the neural dynamics due to ankle joint traction, which has not been verified so far, and to quantify the amount of movement using ultrasound. The results of this study can avoid iatrogenic nerve damage caused by ankle arthroscopy, and thus contribute to the improvement of treatment outcomes.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Patients undergoing foot/ankle joint surgery after March 2023 at Chiba University Hospital are eligible. On the day of surgery, the distance from the skin to the superficial/deep fibular nerve is measured using ultrasonography before surgery. Also measure the distance from the lateral edge of the third peroneal tendon for the superficial peroneal nerve, and the distance from the lateral edge of the extensor hallucis longus tendon for the deep peroneal nerve. After anesthesia, the same measurements are taken again, and the amount of change before and after anesthesia is calculated to determine the amount of nerve migration.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Only performed on the day of surgery. After anesthesia, a strap is attached to the ankle joint and connected to a traction device to pull the ankle joint. The traction force is about 5 kgf and the traction time is about 5 minutes.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who will undergo foot/ankle joint surgery after March 2023 at Chiba University Hospital.

Key exclusion criteria

1) History of ankle surgery, 2) Traumatic injury to the ankle joint, 3) Obesity with a Body mass index of 30 or higher, 4) Long-term surgery is scheduled under lumbar spinal anesthesia, 5) Under the age of 18

Target sample size

50

Name of lead principal investigator

1st name	Satoshi
Middle name
Last name	Yamaguchi

Organization

Chiba University

Division name

Graduate School of Global and Transdisciplinary Studies / Graduate School of Medical and Pharmaceutical Sciences, Chiba University

Zip code

260-8677

Address

Graduate School of Medical and Pharmaceutical Sciences, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan

TEL

043-222-7171

Email

y-satoshi@mvb.biglobe.ne.jp

Name of contact person

1st name	Hirofumi
Middle name
Last name	Nakajima

Organization

Chiba university

Division name

Graduate School of Medical and Pharmaceutical Sciences, Chiba University

Zip code

260-8677

Address

Graduate School of Medical and Pharmaceutical Sciences, Chiba University, 1-8-1 Inohana, Chuo-ku, Ch

TEL

043-222-7171

Homepage URL

Email

h.nakaji.0828@gmail.com

Institute

Chiba university

Institute

Department

Personal name

Hirofumi Nakajima

Organization

Not applicable

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Research Ethics Review Committee, Chiba University Hospital

Address

Graduate School of Medical and Pharmaceutical Sciences, Chiba University, 1-8-1 Inohana, Chuo-ku, Ch

Tel

043-222-7171

Email

igaku-rinri@office.chiba-u.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Partially published

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

03

Month

01

Day

Date of IRB

Anticipated trial start date

2023

Year

03

Month

01

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

05

Month

22

Day

Last modified on

2023

Year

05

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058308