UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041100 |
|---|---|
| Receipt number | R000046893 |
| Scientific Title | Assessment of the influence of the weight bearing timing on clinical results after arthroscopic meniscal repair. |
| Date of disclosure of the study information | 2020/07/14 |
| Last modified on | 2023/07/18 10:04:06 |
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Basic information
Public title
Assessment of the influence of the weight bearing timing on clinical results after arthroscopic meniscal repair.
Acronym
Assessment of the influence of the weight bearing timing on clinical results after arthroscopic meniscal repair.
Scientific Title
Assessment of the influence of the weight bearing timing on clinical results after arthroscopic meniscal repair.
Scientific Title:Acronym
Assessment of the influence of the weight bearing timing on clinical results after arthroscopic meniscal repair.
Region
| Japan |
Condition
Condition
meniscal injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the influence of the weight bearing timing on clinical results after arthroscopic meniscal repair.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Post-operative reinjury rate
2.Postoperative reoperation rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Initiate partial weight bearing after 2 weeks immobilization and 2 weeks non-weight-bearing.
Interventions/Control_2
Initiate partial weight bearing after 2 weeks immobilization and 6 weeks non-weight-bearing.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed with meniscus injury, and undergo arthroscopic meniscal repair, and post-operative follow-up until 24 months after surgery is obtained.
Key exclusion criteria
1.Patients with a history of the knee surgery.
2.Patients with knee ligament injury other than anterior cruciate ligament injury.
3.Patients with knee osteoarthritis.(> Kellgren-Laurence grade 1)
4.Patients with inflammatory disease such as rheumatoid arthritis.
5.Patients who underwent autologous osteochondral transplantation concomitant with arthroscopic meniscus surgery.
6.Patients undergoing surgery for posterior meniscus root tear.
7.In addition, those who are judged to be unsuitable for research by the researchers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Etsuo |
| Middle name | |
| Last name | Chosa |
Organization
University of Miyazaki
Division name
Faculty of medicine Department of Orthopaedic Surgery
Zip code
889-1692
Address
5200 KIHARA, KIYOTAKE, MIYAZAKI
TEL
0985-85-0986
chosa@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuji |
| Middle name | |
| Last name | Yokoe |
Organization
University of MIYAZAKI
Division name
Department of orthopaedic surgery, Faculty of medicine
Zip code
889-1692
Address
5200 KIHARA, KIYOTAKE, MIYAZAKI
TEL
0985-85-0986
Homepage URL
takuji_yokoe@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of MIYAZAKI
Institute
Department
Personal name
Funding Source
Organization
University of MIYAZAKI
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
General Affairs Department, University of Miyazaki Hospital
Address
5200 KIHARA, KIYOTAKE, MIYAZAKI 889-1692, JAPAN
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-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
| 2020 | Year | 07 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2026 | 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
| 2020 | Year | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046893
| Research Plan | |
|---|---|
| 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 |
