UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044354
Receipt number R000050656
Scientific Title The Efficacy of Transcatheter Arterial Micro-Embolization for Synovitis after Total Knee Arthroplasty
Date of disclosure of the study information 2021/06/01
Last modified on 2021/05/28 11:54:56

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Basic information

Public title

The Efficacy of Transcatheter Arterial Micro-Embolization for Synovitis after Total Knee Arthroplasty

Acronym

The Efficacy of Transcatheter Arterial Micro-Embolization for Synovitis after Total Knee Arthroplasty

Scientific Title

The Efficacy of Transcatheter Arterial Micro-Embolization for Synovitis after Total Knee Arthroplasty

Scientific Title:Acronym

The Efficacy of Transcatheter Arterial Micro-Embolization for Synovitis after Total Knee Arthroplasty

Region

Japan


Condition

Condition

Chronic post-surgical pain after total knee arthroplasty

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Although total knee arthroplasty (TKA) is an effective treatment for osteoarthritis (OA), postoperative persistent pain may occur and patient satisfaction may be compromised. We have evaluated post-TKA synovitis (total PD score) using the power Doppler method (PD) of the ultrasonography (US), and have found that post-TKA persistent pain is related to the total PD score. post-TKA synovitis is considered to be a new cause of post-TKA persistent pain, and the development of a treatment method is urgently needed.
The purpose of this study is to provide a pilot single-arm prospective study of transcatheter arterial micro-embolization (TAME) in patients with persistent pain and to gain a foothold for the treatment of post-TKA synovitis with TAME.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pain VAS during walking after 6 months of TAME

Key secondary outcomes

Pain VAS at 3, 6, and 12 months after TAME, WOMAC score, assessment of pain and function at 3, 6, and 12 months using the WOMAC score, and assessment of the number and type of adverse events from TAME to the 12-month assessment


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

Maneuver

Interventions/Control_1

transcatheter arterial micro-embolization (TAME)

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

50 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with post-TKA prolonged pain (pain VAS 30 or more) who have received conservative therapy for 3 months and have prolonged pain due to post-TKA synovitis.

Key exclusion criteria

Patients who meet the following criteria: no other conditions that cause pain, no anticoagulant medication, synovitis confirmed by ultrasound, and no problems with surgery on preoperative examination.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Natsuki
Middle name
Last name Sugimura

Organization

Department of Orthopaedics, Kochi University

Division name

Orthopaedics surgery

Zip code

783-8505

Address

185-1 Kohasu, Okochom, Nankoku, Kochi, Japan

TEL

0888802386

Email

sugimura.n@kochi-u.ac.jp


Public contact

Name of contact person

1st name Natsuki
Middle name SUGIMURA
Last name Sugimura

Organization

Kochi university

Division name

Department orthopaedics surgery

Zip code

783-8505

Address

185-1 Oko-cho Kohasu

TEL

0888802386

Homepage URL


Email

sugimura.n@kochi-u.ac.jp


Sponsor or person

Institute

Kochi University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kochi university

Address

Nankoku

Tel

0888802386

Email

sugimura.n@kochi-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



Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 01 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

2021 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2021 Year 08 Month 01 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 28 Day

Last modified on

2021 Year 05 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050656


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name