UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014587
Receipt No. R000016898
Scientific Title Clinical study on treatment for meniscal defect using collagen-based construct.
Date of disclosure of the study information 2014/08/01
Last modified on 2016/02/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical study on treatment for meniscal defect using collagen-based construct.
Acronym Clinical study on treatment for meniscal defect using collagen-based construct.
Scientific Title Clinical study on treatment for meniscal defect using collagen-based construct.
Scientific Title:Acronym Clinical study on treatment for meniscal defect using collagen-based construct.
Region
Japan

Condition
Condition Meniscal Injury
Classification by specialty
Orthopedics Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Objective of this study is to investigate the safety and efficacy of collagen-based construct for meniscal defect, which is a challenging disorder of the knee, lacking a gold standard treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Adverse event data, including type, frequency, severity and duration.
Key secondary outcomes Subjective score by KOOS and VAS
Repair site morphology by MRI
Activity score by Lysholm and Tegner
Arthroscopic evaluation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Meniscus repair
Collagen-based construct implantation at meniscal defect
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
15 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients who are diagnosed as meniscus injury by MRI
2) patients with drug-uncontrollable knee pain
3) patients who has meniscus defect more than 10 mm2 after trimming
Key exclusion criteria 1) Patients with knee osteoarthritis of Kellgren-Lawrence grade III or IV
2) Patients with allergic or atopic tendency
3) Patients with infections (positive for HIV, HBV, HCV, or HTLV)
4) Patients with active cancer
5) pregnant or possively pregnant patients, patients giving the breast to a child or expecting a child during the study periods
6) psychopathic patients who are considered noncompliant, or unable to understand the significance of this study
7) patients whom the researchers judge to be inappropriate to be enrolled in this study
Target sample size 35

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Ken Nakata
Organization Osaka University Graduate School of Medicine
Division name Medicine for Sports and Performing Arts, Dept of Health and Sport Sciences
Zip code
Address 901 Center of Medical innovation and Translational research, 2-2 Yamadaoka Suita-city, Osaka, Japan
TEL 06-6210-8436
Email ken-nakata@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yasuhiro Take
Organization Osaka University Graduate School of Medicine
Division name Dept of Orthopaedics
Zip code
Address 2-2 Yamadaoka, Suita-city, Osaka, Japan
TEL 06-6889-3552
Homepage URL
Email yasuhiro-take@umin.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University
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
Address
Tel
Email

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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 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 Open public recruiting
Date of protocol fixation
2013 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 18 Day
Last modified on
2016 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016898

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.