UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020442 |
|---|---|
| Receipt number | R000023617 |
| Scientific Title | Patients' satisfaction after Physio-Knee total knee arthroplasty -multicenter study- |
| Date of disclosure of the study information | 2016/01/05 |
| Last modified on | 2024/07/12 10:58:01 |
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Basic information
Public title
Patients' satisfaction after Physio-Knee total knee arthroplasty -multicenter study-
Acronym
Physio-Knee multicenter study
Scientific Title
Patients' satisfaction after Physio-Knee total knee arthroplasty -multicenter study-
Scientific Title:Acronym
Physio-Knee multicenter study
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the patients' satisfaction after Physio-Knee total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Forgotten Joint Score (12 months after operation)
Key secondary outcomes
Ligament balance
Alignment of leg (2-4 weeks after operation)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Candidates for primary total knee arthroplasty using Physio-Knee system
Key exclusion criteria
Patients with contra-indication for total knee arthroplasty
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Yukihide |
| Middle name | |
| Last name | Minoda |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
5458585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3851
yminoda@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yukihide |
| Middle name | |
| Last name | Minoda |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
5458585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3851
Homepage URL
yminoda@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KYOCERA Medical Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Graduate School of Medicine
Address
1-5-7, Asahimachi, Abeno-ku, Osaka
Tel
06-6645-3435
e-shio@med.osaka-cu.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
| 2016 | Year | 01 | Month | 05 | 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
144
Results
Forgotten Joint Score (12 months after operation) was 56+/-26(mean+/-SD).
Results date posted
| 2024 | Year | 07 | Month | 12 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Data analysis takes time
Date of the first journal publication of results
Baseline Characteristics
The patient age was 77+/-7 years, height 152+/-8 cm, and weight 60+/-11 kg. Preoperative extension angle was -9+/-7 degrees, and flexion angle was 114+/-18 degrees.
Participant flow
TKA was performed and clinical evaluation was performed 12 months after surgery.
Adverse events
There was no adverse events.
Outcome measures
The operation time was 104+/-28 minutes, and the dermatome was 13+/-2cm.
The distal femoral osteotomy angle was 6+/-1 degrees, and the posterior condyle osteotomy angle was 3+/-1 degrees.
Postoperative HKA was 2+/-4 degrees, alpha angle 95+/-3 degrees, beta angle 88+/-7 degrees, gamma angle 2+/-8 degrees, and delta angle 87+/-13 degrees.
Postoperative range of motion was extension -2+/-5 degrees, flexion 119+/-13 degrees.
Knee Society Score improved from 41+/-18 points to 85+/-23 points, and function from 38+/-17 points to 66+/-24 points.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | 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
Obseravation
Management information
Registered date
| 2016 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023617
