UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014587
Receipt number 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 2021/10/27 15:32:33

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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

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

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 or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2013 Year 12 Month 04 Day

Date of IRB

2014 Year 07 Month 08 Day

Anticipated trial start date

2014 Year 09 Month 01 Day

Last follow-up date

2020 Year 05 Month 28 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 10 Month 07 Day


Other

Other related information



Management information

Registered date

2014 Year 07 Month 18 Day

Last modified on

2021 Year 10 Month 27 Day



Link to view the page

Value
https://center6.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