UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049309 |
|---|---|
| Receipt number | R000056098 |
| Scientific Title | Change in knee kinematics and meniscal position before and after treatment for meniscal tear. |
| Date of disclosure of the study information | 2022/10/25 |
| Last modified on | 2023/04/26 12:06:43 |
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Basic information
Public title
Cange in knee motion and meniscal position before and after treatment for meniscal tear.
Acronym
Meniscal treatment trial
Scientific Title
Change in knee kinematics and meniscal position before and after treatment for meniscal tear.
Scientific Title:Acronym
Meniscal treatment trial
Region
| Japan |
Condition
Condition
meniscal tear
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is estimated that as many as 25.3 million people suffer from knee osteoarthritis in Japan. Therefore, it is important to reduce the incidence of knee osteoarthritis in Japan in order to extend healthy life expectancy and reduce medical costs. Among these, meniscus injuries are the most common knee injury and have been reported to be an independent risk factor for the development of knee osteoarthritis. Partial meniscectomy has been reported to accelerate the progression of knee osteoarthritis in the long term, and meniscus suture has been widely used in recent years to preserve meniscus function. However, the re-tear rate is high, and there are very few reports on the long-term prognosis of osteoarthritis. One of the factors that contribute to the development of knee osteoarthritis is changes in knee joint motion. It is believed that the cartilage of the human knee joint thickens in response to knee joint motion during walking, and that changes in motion due to trauma cause changes in the stress on the cartilage, which in turn induce synovitis. However, as far as the applicant has been able to find, there are no detailed reports on the changes in knee joint motion during gait after meniscus injury or meniscus suture surgery. These changes in gait are thought to be related to changes in the condition of the meniscus itself, such as its position, as well as changes in physical functions before and after injury. If the effects of physical function on gait kinematics after knee meniscus treatment can be clarified, evidence-based pioneering postoperative rehabilitation will be possible.Based on the above background, this study aims to clarify the following three points. The three main questions are: 1) changes in knee joint kinematics before and after meniscal injury treatment; 2) changes in meniscal kinematics and physical function after treatment; and 3) the relationship between 1) and 2).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire on knee,knee kinetics during movement, kinematic data and muscle strength before and after(3, 6, 12, 24 months) treatment.
Key secondary outcomes
meniscal position, joint range of motion, kinematics and kinetics of other joint, flexibility and ground reaction force before and after(3, 6, 12, 24 months) treatment.
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
| 10 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have obtained written consent to participate in the study from the individual or a surrogate.
Patients with a diagnosis of meniscus injury based on imaging and physical findings by a physician.
Patients who are able to walk unaided without the use of a walking aid.
Key exclusion criteria
Patients with a medical history of ipsilateral knee joint within 1 year.
History of orthopedic surgery on lower limb.
Patients with a medical history that affects movement.
Patients with contraindications to MRI measurements.
Those who are judged to be inappropriate as research subjects by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Ogata |
Organization
Kurume university medical center
Division name
Division of rehabilitation center
Zip code
839-0863
Address
155-1 Kokubumachi, Kurume-shi, Fukuoka-ken, Japan
TEL
0942-22-6111
ogata_yuuta@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Ogata |
Organization
Kurume university medical center
Division name
Division of rehabilitation center
Zip code
839-0863
Address
155-1 Kokubumachi, Kurume-shi, Fukuoka-ken, Japan
TEL
0942-22-6111
Homepage URL
ogata_yuuta@kurume-u.ac.jp
Sponsor or person
Institute
Division of rehabilitation center, Kurume university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Committee of Kurume University
Address
67 Asahimachi, Kurume-shi, Fukuoka-ken, Japan
Tel
0942-35-3311
i_rinri@kurume-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
| 2022 | Year | 10 | Month | 25 | 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
No adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe gait, symptoms, and physical function before and at 3, 6, and 12 months after treatment. Then, we investigate the relationship between each outcomes.
Management information
Registered date
| 2022 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056098
