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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024949
Receipt No. 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

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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
Email 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
Email mishikawa@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028703

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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