UMIN-CTR Clinical Trial

Basic information
Public title	Efficasy of a cementless total knee arthroplasty.
Acronym	Efficasy of a cementless total knee arthroplasty.
Scientific Title	Efficasy of a cementless total knee arthroplasty.
Scientific Title:Acronym	Efficasy of a cementless total knee arthroplasty.
Region	Japan

Condition
Condition	Osteoarthrotis, Osteonecrosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficasy of a cementless total knee arthroplasty, this study will compare clinical outcomes of cement and cementless total knee arthroplasty.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical evaluation and plane radiographic findings at 1 year after total knee arthroplasty.
Key secondary outcomes	Clinical evaluation and plane radiographic findings at 3 and 6 months after total knee arthroplasty.

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 procedure of cementless total knee arthroplasty. Cementless group 20 cases.
Interventions/Control_2	Surgical procedure of cement total knee arthroplasty. Cement group 20 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases who adapted to total knee arthroplasty and obtained consent by document.
Key exclusion criteria	Cases which reserchers judge inappropriate(example revision surgery)
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name Minami
Organization	Sumiya orthopaedics hospital
Division name	Department of orthopaedics surgery
Zip code	640-8343
Address	337 Yoshida, Wakayama
TEL	073-433-1161
Email	crddp728@yahoo.co.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Minami
Organization	Sumiya orthopaedics hospital
Division name	Department of orthopaedics surgery
Zip code	640-8343
Address	337 Yoshida, Wakayama
TEL	073-433-1161
Homepage URL
Email	crddp728@yahoo.co.jp

Sponsor
Institute	Sumiya orthopaedics hospital
Institute
Department

Funding Source
Organization	None
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	Sumiya orthopaedics hospital
Address	337 Yoshida, Wakayama
Tel	073-433-1161
Email	sanada@sumiya.or.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	2018 Year 06 Month 01 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	Terminated
Date of protocol fixation	2018 Year 03 Month 20 Day
Date of IRB	2018 Year 05 Month 15 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2022 Year 06 Month 01 Day
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 24 Day
Last modified on	2022 Year 11 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037291