UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037630 |
|---|---|
| Receipt number | R000042902 |
| Scientific Title | Influence of Bone Filling for Tibial Peg Holes in Cementless Total Knee Arthroplasty: Investigation of Patients with Simultaneous Bilateral Surgery |
| Date of disclosure of the study information | 2019/08/08 |
| Last modified on | 2019/08/08 11:12:57 |
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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
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
hkazue@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042902
