UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043281 |
|---|---|
| Receipt number | R000049406 |
| Scientific Title | The Effect of Alignment Change on Knee Joint Pressure Distribution in Unicompartmental Knee Arthroplasty |
| Date of disclosure of the study information | 2021/02/08 |
| Last modified on | 2021/02/08 16:11:01 |
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Basic information
Public title
The Effect of Alignment Change on Knee Joint Pressure Distribution in Unicompartmental Knee Arthroplasty
Acronym
The Effect of Alignment Change on Knee Joint Pressure Distribution in Unicompartmental Knee Arthroplasty
Scientific Title
The Effect of Alignment Change on Knee Joint Pressure Distribution in Unicompartmental Knee Arthroplasty
Scientific Title:Acronym
The Effect of Alignment Change on Knee Joint Pressure Distribution in Unicompartmental Knee Arthroplasty
Region
| Japan |
Condition
Condition
Knee Osteoarthritis or Knee Osteonecrosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of alignment changes on joint load distribution in Unicompartmental knee arthroplasty.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to predict osteoarthritis of the lateral epicondyle, sub-implant fractures, and tibial surface wear from changes in joint load distribution.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum pressure at the epicondylar joint surface of the tibia
Key secondary outcomes
Maximum pressure just below the tibial baseplate
Maximum pressure on tibial surface
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone unicompartmental knee replacement surgery for osteoarthritis or osteonecrosis of the femoral epicondyle and have given consent for this study.
Key exclusion criteria
Patients with missing preoperative and postoperative CT, 3T-MRI 3T 0.6 mm slice, or pre- and postoperative full-extremity standing simple x-rays
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | NATSUKI |
| Middle name | |
| Last name | SUGIMURA |
Organization
Kochi university
Division name
Orthopaedics
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku city, Kochi
TEL
0888802386
jm-snatsuki@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | NATSUKI |
| Middle name | |
| Last name | SUGIMURA |
Organization
Kochi university
Division name
Orthopeadics
Zip code
783-8505
Address
185-1 Oko-cho Kohasu
TEL
0888802386
Homepage URL
sugimura.n@kochi-u.ac.jp
Sponsor or person
Institute
Dept. of Orthop., Kochi Uni.
Institute
Department
Personal name
Funding Source
Organization
Dept. of Orthop., Kochi Uni.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi university
Address
185-1 Oko-cho Kohasu
Tel
0888802386
sugimura.n@kochi-u.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 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None in particular.
Management information
Registered date
| 2021 | Year | 02 | Month | 08 | Day |
Last modified on
| 2021 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049406
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
