Unique ID issued by UMIN | UMIN000014587 |
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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 |
Clinical study on treatment for meniscal defect using collagen-based construct.
Clinical study on treatment for meniscal defect using collagen-based construct.
Clinical study on treatment for meniscal defect using collagen-based construct.
Clinical study on treatment for meniscal defect using collagen-based construct.
Japan |
Meniscal Injury
Orthopedics | Adult | Child |
Others
NO
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.
Safety,Efficacy
Exploratory
Phase II
Adverse event data, including type, frequency, severity and duration.
Subjective score by KOOS and VAS
Repair site morphology by MRI
Activity score by Lysholm and Tegner
Arthroscopic evaluation
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
Meniscus repair
Collagen-based construct implantation at meniscal defect
15 | years-old | <= |
60 | years-old | > |
Male and Female
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
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
35
1st name | |
Middle name | |
Last name | Ken Nakata |
Osaka University Graduate School of Medicine
Medicine for Sports and Performing Arts, Dept of Health and Sport Sciences
901 Center of Medical innovation and Translational research, 2-2 Yamadaoka Suita-city, Osaka, Japan
06-6210-8436
ken-nakata@umin.ac.jp
1st name | |
Middle name | |
Last name | Yasuhiro Take |
Osaka University Graduate School of Medicine
Dept of Orthopaedics
2-2 Yamadaoka, Suita-city, Osaka, Japan
06-6889-3552
yasuhiro-take@umin.ac.jp
Osaka University Graduate School of Medicine
Osaka University
Other
NO
大阪大学医学部附属病院
2014 | Year | 08 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 12 | Month | 04 | Day |
2014 | Year | 07 | Month | 08 | Day |
2014 | Year | 09 | Month | 01 | Day |
2020 | Year | 05 | Month | 28 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 10 | Month | 07 | Day |
2014 | Year | 07 | Month | 18 | Day |
2021 | Year | 10 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016898
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