UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000028703