UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031340 |
|---|---|
| Receipt number | R000035316 |
| Scientific Title | The effect of low signal intensity pulsed ultrasound to articular cartilage and meniscus |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2025/02/23 12:22:56 |
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Basic information
Public title
The effect of low signal intensity pulsed ultrasound to articular cartilage and meniscus
Acronym
The effect of LIPUS to articular cartilage and meniscus
Scientific Title
The effect of low signal intensity pulsed ultrasound to articular cartilage and meniscus
Scientific Title:Acronym
The effect of LIPUS to articular cartilage and meniscus
Region
| Japan |
Condition
Condition
medial meniscus posterior root tear
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to show that LIPUS controls degenerative change of meniscus and cartilage following medial meniscus posterior root tear and that clinical outcome gets better after medial meniscus repair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate change of intra-meniscal signal intensity, medial meniscus extrusion, and thickness of cartilage on magnetic resonance imaging which is performed preoperatively and 3/12 postoperatively.
Key secondary outcomes
If we have to perform partial meniscectomy due to meniscal tear, we perform gene analysis or immunostaining by using that tissue.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
LIPUS (blinded) is applied to the point around injured meniscus 20 minutes everyday before surgery to 2 weeks after surgery.
Interventions/Control_2
Dummy (blinded) is applied to the point around injured meniscus 20 minutes everyday before surgery to 2 weeks after surgery.
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
patients who injured medial meniscus posterior root tear
Key exclusion criteria
patients who has undergone some previous surgery to the ipsilateral knee
patients who has been treated by LIPUS for other disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Furumatsu |
Organization
Okayama university hospital
Division name
Orthopaedic surgery
Zip code
Address
2-5-1, shikatacho, kita-ku, okayama city, okayama
TEL
086-223-7151
matino@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Furumatsu |
Organization
Okayama university hospital
Division name
Orthopaedic surgery
Zip code
Address
2-5-1, shikatacho, kita-ku, okayama city, okayama
TEL
086-223-7151
Homepage URL
matino@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
Funding Source
Organization
The japanese foundation for research and promotion of endscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035316
