UMIN-CTR Clinical Trial

Basic information
Public title	Influence of Bone Filling for Tibial Peg Holes in Cementless Total Knee Arthroplasty: Investigation of Patients with Simultaneous Bilateral Surgery
Acronym	Influence of Bone Filling for Tibial Peg Holes in Cementless Total Knee Arthroplasty: Investigation of Patients with Simultaneous Bilateral Surgery
Scientific Title	Influence of Bone Filling for Tibial Peg Holes in Cementless Total Knee Arthroplasty: Investigation of Patients with Simultaneous Bilateral Surgery
Scientific Title:Acronym	Influence of Bone Filling for Tibial Peg Holes in Cementless Total Knee Arthroplasty: Investigation of Patients with Simultaneous Bilateral Surgery
Region	Japan

Condition
Condition	Osteoarthritis, rhumatoid 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 arthroplasty.
Basic objectives2	Safety
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	Bone graft in total knee arthroplasty
Interventions/Control_2	Nomal 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 obtaind consent by document
Key exclusion criteria	Patiens attending physicinan has determined ineligible(example bone defect, posterior cruciate ligament injury)
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kazue Middle name Last name Hayakawa
Organization	Fujita Health University School of Medicine
Division name	Department of Orthopaedic Surgery
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
TEL	0562932169
Email	hkazue@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Kazue Middle name Last name Hayakawa
Organization	Fujita Health University School of Medicine
Division name	Department of Orthoaedic Surgery
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
TEL	0562932169
Homepage URL
Email	hkazue@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
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
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
Tel	0562932865
Email	f-irb@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 Halth University Hospital (Aichi)

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 08 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	2018 Year 12 Month 21 Day
Date of IRB	2019 Year 04 Month 12 Day
Anticipated trial start date	2019 Year 04 Month 12 Day
Last follow-up date	2022 Year 12 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	2019 Year 08 Month 08 Day
Last modified on	2019 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042902