UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective randomized two-group comparative clinical study of patient satisfaction after total knee arthroplasty using Persona articular surface implants
Title of the study (Brief title)	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	Kazue Hayakawa
Organization	Fujita health university school of medicine
Division name	Department of Orthopaedic Surgery
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	Kazue Hayakawa
Organization	Fujita health university school of medicine
Division name	Department of Orthoaedic Surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 02 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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