UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024949 |
|---|---|
| Receipt number | R000028703 |
| Scientific Title | Development of new arthroscopic evaluation method for meniscus injury with ultra-fine needle scope |
| Date of disclosure of the study information | 2016/12/06 |
| Last modified on | 2019/05/26 12:06:04 |
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Basic information
Public title
Development of new arthroscopic evaluation method for meniscus injury with ultra-fine needle scope
Acronym
Development of new arthroscopic evaluation method with ultra-fine needle scope
Scientific Title
Development of new arthroscopic evaluation method for meniscus injury with ultra-fine needle scope
Scientific Title:Acronym
Development of new arthroscopic evaluation method with ultra-fine needle scope
Region
| Japan |
Condition
Condition
meniscus injury in the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate safety and efficacy of ultra-fine needle scope and develop less invasive and more promising arthroscopic evaluation method for meniscus injury.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate of diagnosis of meniscus injury in the knee between ultra-fine needle and conventional scope
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients will be admitted to the Hiroshima University hospital with general manner and anesthetized at operation room (anesthesia method will be decided by anesthesiologist). Following conventional arthroscopic examination, patients' body temperature and ECG will be monitored.
At first, under anesthesia, ultra-fine needle scope is inserted to the joint space at the sites of anteromedial and anterolateral portals without incision . According to conventional arthroscopic examination, medial and lateral menisci and other structures such as ligament and articular cartilage will be observed. All subjects are recorded as images and movies in specific hard disc drive.
Interventions/Control_2
Second, incisions will be place to create anteromedial and anterolatearal portals, then conventional scope will be inserted. Observation of subjects will be done with same manner. Stored images and movies in the disc drive will be kept secured place until analysis.
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
1. Over 20 years old
2. Diagnosed as meniscus injury from preoperative X-ray, CT, and MRI images
3. Patients who is planed arthroscopic examination or treatment
4. Patients consented to being enrolled this study with specific form
Key exclusion criteria
1. Severe obesity (BMI > 35)
2. Patients who is diagnosed as inappropriate case by orthopaedic surgeon in charge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Adachi |
Organization
Hiroshima University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5230
nadachi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Ishikawa |
Organization
Hiroshima University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5233
Homepage URL
mishikawa@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Sumita Optical Glass, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Integrated Medical Research
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
Tel
082-257-1752
protocol@cimr.hiroshima-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
| 2016 | Year | 12 | Month | 06 | 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
40
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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2016 | Year | 11 | Month | 22 | Day |
Last modified on
| 2019 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028703
| 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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