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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019941
Receipt No. R000023024
Scientific Title The clinical study on the effectiveness of bone graft to the tibial interface in cementless total knee replacement
Date of disclosure of the study information 2015/11/26
Last modified on 2019/05/31

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Basic information
Public title The clinical study on the effectiveness of bone graft to the tibial interface in cementless total knee replacement
Acronym The clinical study on the effectiveness of bone graft to the tibial interface in cementless total knee replacement
Scientific Title The clinical study on the effectiveness of bone graft to the tibial interface in cementless total knee replacement
Scientific Title:Acronym The clinical study on the effectiveness of bone graft to the tibial interface in cementless total knee replacement
Region
Japan

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

Objectives
Narrative objectives1 Purpose of the study:to reveal of the effectiveness of bone graft to the tibial interface in cementless total knee replacement.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Plain radiograph evaluation and bone density in 1 year after surgery.
Key secondary outcomes Relationship between lower limb alignment and radiological-change surrounding pegs of tibial component.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Resected bone graft in total knee arthroplasty.
Interventions/Control_2 Normal 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) the case that adapted to total knee arthroplasty.
(2) the case who obtained consent by document
Key exclusion criteria Patients attending physician has determined ineligible(example bone defect, posterior cruciate ligament injury).
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kazue
Middle name
Last name Hayakawa
Organization Fujita Health University Hospital
Division name Department of Orthopaedic Surgery
Zip code 4580919
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 Kazue
Middle name
Last name Hayakawa
Organization Fujita Health University Hospital
Division name Department of Orthopaedic Surgery
Zip code 4701192
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 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 Fujita Health University Hospital
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
Tel 0562932169
Email hkazue@fujita-hu.ac.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 藤田医科大学病院(愛知県)/Fujita Health University Hospital(Aichi)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 26 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
2015 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 20 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
2015 Year 11 Month 26 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023024

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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