UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043240
Receipt number R000049348
Scientific Title The Effect of Posterior Slope of Tibial Component in Unicompartmental Arthroplasty on the Kinematics
Date of disclosure of the study information 2021/02/10
Last modified on 2022/08/08 11:22:29

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Basic information

Public title

The Effect of Posterior Slope of Tibial Component in Unicompartmental Arthroplasty on the Kinematics

Acronym

The Effect of Posterior Slope of Tibial Component in Unicompartmental Arthroplasty on the Kinematics

Scientific Title

The Effect of Posterior Slope of Tibial Component in Unicompartmental Arthroplasty on the Kinematics

Scientific Title:Acronym

The Effect of Posterior Slope of Tibial Component in Unicompartmental Arthroplasty on the Kinematics

Region

Japan


Condition

Condition

Knee osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the effect of posterior slope of tibial component in unicompartmental arthroplasty on the kinematics.

Basic objectives2

Others

Basic objectives -Others

none in particular

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Range of motion

Key secondary outcomes

The difference of the tibial rotation in extension and flexion.
The difference of the tibial antero-postero translation in extension and flexion.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

To change the tibial surface trial to +-2 degree and +- 4 degree.

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 to take unicompartmental arthroplasty for the knee osteoarthritis

Key exclusion criteria

Cases where stryker navigation system was not used

Target sample size

40


Research contact person

Name of lead principal investigator

1st name NATSUKI
Middle name SUGIMURA
Last name SUGIMURA

Organization

Dept. of Orthop. Surg. Kochi Uni.

Division name

Orthopeadics surgery

Zip code

783-8505

Address

185-1 Oko-cho Kohasu

TEL

0888802386

Email

sugimra.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

Orthopeadics Surgery

Zip code

783-8505

Address

Nankoku

TEL

0888802386

Homepage URL


Email

sugimura.n@kochi-u.ac.jp


Sponsor or person

Institute

Kochi univerity

Institute

Department

Personal name



Funding Source

Organization

Kochi university

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

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 02 Month 10 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

Open public recruiting

Date of protocol fixation

2021 Year 02 Month 10 Day

Date of IRB

2021 Year 05 Month 14 Day

Anticipated trial start date

2021 Year 02 Month 10 Day

Last follow-up date

2025 Year 02 Month 10 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 02 Month 04 Day

Last modified on

2022 Year 08 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049348


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name