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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043422
Receipt No. 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

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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
Institute Fujita health university school of medicine
Institute
Department

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
URL(English) https://upload.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


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