UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043422 |
|---|---|
| Receipt number | R000049577 |
| Scientific Title | A randomized, prospective, comparative study of cemented and cementless total knee arthroplasty using the Persona trabecular metal tibial component |
| Date of disclosure of the study information | 2021/02/23 |
| Last modified on | 2024/09/08 20:01:48 |
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Basic information
Public title
A randomized, prospective, comparative study of cemented and cementless total knee arthroplasty using the Persona trabecular metal tibial component
Acronym
Randomized, prospective, comparative study of the Persona trabecular metal tibial component with or without cement
Scientific Title
A randomized, prospective, comparative study of cemented and cementless total knee arthroplasty using the Persona trabecular metal tibial component
Scientific Title:Acronym
Randomized, prospective, comparative study of the Persona trabecular metal tibial component with or without cement
Region
| Japan |
Condition
Condition
To evaluate whether the initial fixation force is increased if bone cement is applied only to the tray part of the Persona TM tibial component
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the initial fixation force is increased if bone cement is applied only to the tray part of the Persona TM tibial component
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in bone near the peg by plain X-ray
Key secondary outcomes
Changes in bone density near the tibial peg over time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Standard cementless total knee arthroplasty
Interventions/Control_2
cemented TKA
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients giving voluntary written informed consent to participate in the study
Patients aged 50 years or older
Patients undergoing initial TKA
Osteoarthritis (OA), rheumatoid arthritis (RA), idiopathic osteonecrosis of the medial femoral condyle
Key exclusion criteria
Patients who cannot attend postoperative follow-up at Months 1, 3, 6, and Year 1
Patients not suitable for Persona TM tibia (large bone defect, ligament imbalance, damage to posterior cruciate ligament, revision TKA)
Patients whom the investigator/sub-investigator consider unsuitable for this study
Target sample size
100
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
Orthopedicas
Zip code
4701192
Address
1-98 Dengakugakubo Kutsukakecho Toyoake City
TEL
+81562932169
hkazue@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kaszue |
| Middle name | |
| Last name | Hayakawa |
Organization
Fujita health university school of medicine
Division name
Orthopedics
Zip code
4701192
Address
1-98 Dengakugakubo Kutsukakecho Toyoake City
TEL
+81562932169
Homepage URL
hkazue@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita health university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Fujita health university school of medicine
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 Kutuskakecho
Tel
+81562932169
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
The cementation group can be expected to increase the initial fixation force and is a useful techniq
Number of participants that the trial has enrolled
110
Results
The operative time was 91.2/80.9 minutes, postoperative KSS 94.6/95.0, KSFS 82.0/83.5, HKA (absolute value) 1.0/0.8.The 2011 KSS and KOOS were not significantly different. The tibia subsidence was 0/5, and the appearance of the vertical bony ridge below the peg was 16/6 . BMD in the cemented group decreased over time as in the normal group and was lower than in the normal group at all sites.
Results date posted
| 2024 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 08 | Day |
Baseline Characteristics
From March 021 to November 2022, 83 patients with 110 joints (52 in the cemented group and 58 in the normal group), 15 males and 68 females, mean age 77.6 years, underwent persona CR cementless TKA after being prospectively randomized to the cemented or normal group.
Participant flow
Adverse events
None
Outcome measures
operetion time, ntraoperative findings,Knee Society Score, Knee Society Functional Score , FTA,HKA, 2011KSS, KOOS, BMD
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2021 | Year | 02 | Month | 23 | Day |
Last modified on
| 2024 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049577
