UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043422
Receipt number R000049577
Scientific Title A randomized, prospective, comparative study of cemented and cementless total knee arthroplasty using the Persona trabecular metal tibial component
Date of disclosure of the study information 2021/02/23
Last modified on 2021/02/23 16:42:04

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Basic information

Public title

A randomized, prospective, comparative study of cemented and cementless total knee arthroplasty using the Persona trabecular metal tibial component

Acronym

Randomized, prospective, comparative study of the Persona trabecular metal tibial component with or without cement

Scientific Title

A randomized, prospective, comparative study of cemented and cementless total knee arthroplasty using the Persona trabecular metal tibial component

Scientific Title:Acronym

Randomized, prospective, comparative study of the Persona trabecular metal tibial component with or without cement

Region

Japan


Condition

Condition

To evaluate whether the initial fixation force is increased if bone cement is applied only to the tray part of the Persona TM tibial component

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate whether the initial fixation force is increased if bone cement is applied only to the tray part of the Persona TM tibial component

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in bone near the peg by plain X-ray

Key secondary outcomes

Changes in bone density near the tibial peg over time


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Standard cementless total knee arthroplasty

Interventions/Control_2

cemented TKA

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 giving voluntary written informed consent to participate in the study
Patients aged 50 years or older
Patients undergoing initial TKA
Osteoarthritis (OA), rheumatoid arthritis (RA), idiopathic osteonecrosis of the medial femoral condyle

Key exclusion criteria

Patients who cannot attend postoperative follow-up at Months 1, 3, 6, and Year 1
Patients not suitable for Persona TM tibia (large bone defect, ligament imbalance, damage to posterior cruciate ligament, revision TKA)
Patients whom the investigator/sub-investigator consider unsuitable for this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kazue
Middle name
Last name Hayakawa

Organization

Fujita health university school of medicine

Division name

Orthopedicas

Zip code

4701192

Address

1-98 Dengakugakubo Kutsukakecho Toyoake City

TEL

+81562932169

Email

hkazue@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Kaszue
Middle name
Last name Hayakawa

Organization

Fujita health university school of medicine

Division name

Orthopedics

Zip code

4701192

Address

1-98 Dengakugakubo Kutsukakecho Toyoake City

TEL

+81562932169

Homepage URL


Email

hkazue@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita health university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Fujita health university school of medicine

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

Fujita health university

Address

1- 98 Dengakugakubo Kutuskakecho

Tel

+81562932169

Email

hkazue@fujita-hu.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 23 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

Enrolling by invitation

Date of protocol fixation

2021 Year 02 Month 23 Day

Date of IRB

2020 Year 12 Month 21 Day

Anticipated trial start date

2021 Year 03 Month 03 Day

Last follow-up date

2025 Year 07 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 02 Month 23 Day

Last modified on

2021 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049577


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name