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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032537
Receipt No. R000037107
Scientific Title Prospective randomized two-group comparative clinical study of patient satisfaction after total knee arthroplasty using Persona articular surface implants
Date of disclosure of the study information 2018/05/10
Last modified on 2018/05/10

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Basic information
Public title Prospective randomized two-group comparative clinical study of patient satisfaction after total knee arthroplasty using Persona articular surface implants
Acronym Randomized two-group comparison of Persona articular surface implants
Scientific Title Prospective randomized two-group comparative clinical study of patient satisfaction after total knee arthroplasty using Persona articular surface implants
Scientific Title:Acronym Randomized two-group comparison of Persona articular surface implants
Region
Japan

Condition
Condition Osteoarthritis, Rhumatoid Arthritis, Osteonecrosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will compare the level of patient satisfaction after CR-type TKA with ACL resection in the Persona MC surface (test) group and the conventional Persona CR surface (control) group, between which the only difference is the Persona surface implant used, to determine which knee prosthesis is associated with greater patient satisfaction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Plain X-ray findings and clinical evaluation at one year after TKA.
Key secondary outcomes Plain X-ray findings and clinical evaluation at 6 months after TKA.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Surgical maneuver of total knee arthroplasty

MC surface group 60 cases
Interventions/Control_2 Surgical maneuver of total knee arthroplasty

CR surface group 60 cases
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
55 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the case that adapted to total knee arthroplasty


the case who obtained consent by document
Key exclusion criteria Patients attending physician has determined ineligible (example psterior cruciate ligament injury)
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazue Hayakawa
Organization Fujita health university school of medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 1-98 Dengakugakubo,Kutsukake-cho,Toyoake-city,Aichi,Japan
TEL 0562-93-2169
Email hkazue@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazue Hayakawa
Organization Fujita health university school of medicine
Division name Department of Orthoaedic Surgery
Zip code
Address 1-98 Dengakugakubo, kutsukake-cho,Toyoake-city,Aichi,japan
TEL 0562-93-2169
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
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
2018 Year 05 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 10 Day
Last modified on
2018 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037107

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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