UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038577 |
|---|---|
| Receipt number | R000037106 |
| Scientific Title | Prospective randomized two-group comparative clinical study of patient satisfaction after total knee arthroplasty using Persona articular surface implants |
| Date of disclosure of the study information | 2019/11/14 |
| Last modified on | 2024/09/06 00:08:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective randomized two-group comparative clinical study of patient satisfaction after total knee arthroplasty using Persona articular surface implants
Acronym
Randomized two-group comparison of Persona articular surface implants
Scientific Title
Prospective randomized two-group comparative clinical study of patient satisfaction after total knee arthroplasty using Persona articular surface implants
Scientific Title:Acronym
Randomized two-group comparison of Persona articular surface implants
Region
| Japan |
Condition
Condition
Osteoarthritis, Rhumatoid Arthritis, Osteonecrosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will compare the level of patient satisfaction after CR-type TKA with ACL resection in the Persona MC surface (test) group and the conventional Persona CR surface (control) group, between which the only difference is the Persona surface implant used, to determine which knee prosthesis is associated with greater patient satisfaction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plain X-ray findings and clinical evaluation at one year after TKA.
Key secondary outcomes
Plain X-ray findings and clinical evaluation at 6 months after TKA.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Surgical maneuver of total knee arthroplasty
MC surface(test) 60 cases
Interventions/Control_2
Surgical maneuver of total knee arthroplasty
CR surface(control) 60 cases
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
| 55 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the case that adapted to total knee arthroplasty
the case who obtained consent by document
Key exclusion criteria
Patients attending physician has determined ineligible
example posterior cruciate ligament injury
Target sample size
120
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 school of medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 14 | Day |
Related information
URL releasing protocol
Patients were prospectively randomly assigned to either the MC or CR insert groups.
Publication of results
Unpublished
Result
URL related to results and publications
The clinical outcomes and patient satisfaction in the MC group were similar to those in the CR group
Number of participants that the trial has enrolled
158
Results
Flexion angle 113.6/115.5 in MC/CR group ,KSS (points) 89.6/89.5, KSFS (points) 84.2/82.8, pain 19.9/19.7, satisfaction 25.0/24.6, expectation 9.1/8.7, activity 60.6/54.0 in 2011KSS (points), KOOS 77.8/78.3, pain 78.8/80.7, ADL 76.3/74.0, sports 38.7/36.7, QOL 60.4/55.9 were not significantly different between the two groups. The mean %CP of the MC/CR group was 70.0/69.8 immediately after surgery, 62.9/59.2 at 1 year after surgery (p < 0.05), and 61.2/56.8 at 2 years after surgery (p < 0.05).
Results date posted
| 2024 | Year | 09 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From March 2018 to March 2021, 122 patients (77 in the MC group and 81 in the CR group) were prospectively randomized to the MC or CR group and underwent persona CR TKA, and 158 joints (77 in the MC group and 81 in the CR group) were eligible for follow-up. The mean age at surgery was 74.8 years, and there were 113 cases of knee osteoarthritis and 9 cases of rheumatoid arthritis.
Participant flow
There were 140 cases and 182 knees enrolled, of which 122 cases and 158 joints were available for follow-up observation.
Adverse events
none
Outcome measures
The survey items were ROM, KSS (Knee Society Score), KSFS (Knee Society Functional Score), 2011 KSS, KOOS (Knee Injury and Osteoarthritis Outcome Score), FTA, and HKA (absolute value). Posterior stability was evaluated by measuring the %CP (tibiofemoral contact point) using a gravity sag view on simple radiographs up to 2 years after surgery.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2021 | 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 | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037106
