UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020298
Receipt number R000023441
Scientific Title Does the ROM-ex start timing effect the outcome and swelling after TKA ? -A Prospective Study-
Date of disclosure of the study information 2015/12/22
Last modified on 2023/06/01 10:09:42

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Basic information

Public title

Does the ROM-ex start timing effect the outcome and swelling after TKA ? -A Prospective Study-

Acronym

Does the ROM-ex start timing effect the outcome and swelling after TKA ? -A Prospective Study-

Scientific Title

Does the ROM-ex start timing effect the outcome and swelling after TKA ? -A Prospective Study-

Scientific Title:Acronym

Does the ROM-ex start timing effect the outcome and swelling after TKA ? -A Prospective Study-

Region

Japan


Condition

Condition

osteoarthritis of the knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the best ROM-ex start timing for the reduction of the swelling and leading to the good outcome after TKA.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

the girth of lower legs
(at pre-op, Postope 1, 2, 4wk, 3mo)

Key secondary outcomes

WOMAC score
thigh girth
blood loss
muscle strength


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

start at 1 day: Range of Motion exercise

Interventions/Control_2

start at 4 day: Range of Motion exercise

Interventions/Control_3

start at 7 day: Range of Motion exercise

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patient in TKA for the diagnosis of osteoarthritis

Key exclusion criteria

more than 40kg, less than 120kg, drug abuse, allergy, urinary failure, hepatic failure, heart angina, stroke, with the history of the knee surgery, infection

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kentaro Iwakiri

Organization

Shiraniwa Hospital, Department of Orthopaedic Surgery

Division name

Joint Arthroplasty Center

Zip code


Address

6-10-1 Shiraniwadai Ikoma-city

TEL

0743-70-0022

Email

kenpiecekenpiece@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kentaro Iwakiri

Organization

Shiraniwa Hospital, Department of Orthopaedic Surgery

Division name

Joint Arthroplasty Center

Zip code


Address

6-10-1 Shiraniwadai Ikoma-city

TEL

0743-70-0022

Homepage URL


Email

kenpiecekenpiece@yahoo.co.jp


Sponsor or person

Institute

Shiraniwa Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 12 Month 22 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

Completed

Date of protocol fixation

2015 Year 12 Month 21 Day

Date of IRB

2015 Year 11 Month 01 Day

Anticipated trial start date

2015 Year 12 Month 22 Day

Last follow-up date

2020 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

2015 Year 12 Month 21 Day

Last modified on

2023 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023441


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name