UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019941 |
|---|---|
| Receipt number | 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 | 2024/01/23 00:09:17 |
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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
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
hkazue@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University Hospital
Institute
Department
Personal name
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
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
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
88
Results
Plain radiography showed significant longitudinal thickening of the trabecula below the peg (p < 0.05) and decreased occurrence of reactive lines (p = 0.07) in the bone filling group compared with the conventional group. BMD was significantly higher in the bone filling group in the medial region below the peg at 1, 3, and 6 months and in the central region at 1 and 3 months (all p < 0.05).
Results date posted
| 2024 | Year | 01 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this prospective, randomized, comparative study, we recruited consecutive patients scheduled to undergo TKA at the Department of Orthopedic Surgery, from March 2016 to January 2019.
Participant flow
randomized to the bone filling (48 joints) or conventional group (no bone filling; 40 joints)
Adverse events
none
Outcome measures
We performed clinical and plain radiographic evaluations after the operation and measured bone mineral density (BMD) at 5 sites below the component at 1, 3, 6, and 12 months postoperatively.
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
| 2015 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2019 | 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
| 2015 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023024
