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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032700
Receipt No. R000037291
Scientific Title Efficasy of a cementless total knee arthroplasty.
Date of disclosure of the study information 2018/06/01
Last modified on 2019/05/26

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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 Open public recruiting
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
2019 Year 05 Month 26 Day


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

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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