UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Acronym	Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Scientific Title	Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Scientific Title:Acronym	Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Region	Japan

Condition
Condition	knee osteoarthritis
Classification by specialty	Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Recently, a patient with knee osteoarthritis resistant to conservative therapy has undergone Kinematically aligned total knee arthroplaty. In the present study, the kinematically aligned total knee arthroplasty was compared with mechanically aligned total knee arthroplasty that has been commonly performed in many hospitals.
Basic objectives2	Others
Basic objectives -Others	to evaluate the surgical technique in total knee arthroplaty
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative patient-derived outcome
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are 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	kinematically aligened total knee arthroplaty
Interventions/Control_2	mechanically aligned total knee arthroplasty
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	65 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. osteoarthritis 2. kellgren-Lawrence grade4 3. patients who agreed the present study
Key exclusion criteria	1. Rheumatoid arthritis 2. revision total knee arthroplasty 3. impossible to gait 4. infection
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomoyuki Matsumoto
Organization	Kobe University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Zip code
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	078-382-5111
Email	matsun@m4.dion.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Yuichi Kuroda
Organization	Kobe University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Zip code
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	078-382-5111
Homepage URL
Email	0321yuichi0321@gmail.com

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kobe University Graduate School of Medicine
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
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	2017 Year 04 Month 14 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	Preinitiation
Date of protocol fixation	2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2030 Year 03 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	2017 Year 04 Month 07 Day
Last modified on	2022 Year 10 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030854