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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015497
Receipt No. R000016572
Scientific Title Exploratory research of the efficacy and safety with the enamel matrix derivative for anterior cruciate ligament reconstruction
Date of disclosure of the study information 2014/10/30
Last modified on 2019/08/07

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Basic information
Public title Exploratory research of the efficacy and safety with the enamel matrix derivative for anterior cruciate ligament reconstruction
Acronym Exploratory research of the efficacy and safety with the enamel matrix derivative for anterior cruciate ligament reconstruction
Scientific Title Exploratory research of the efficacy and safety with the enamel matrix derivative for anterior cruciate ligament reconstruction
Scientific Title:Acronym Exploratory research of the efficacy and safety with the enamel matrix derivative for anterior cruciate ligament reconstruction
Region
Japan

Condition
Condition anterior cruciate ligament injury
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Exploratory research of the efficacy and safety with the enamel matrix derivative for anterior cruciate ligament reconstruction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes KT-2000 measurement of anterior knee laxity at postoperative 2 years
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 At anterior cruciate ligament reconstruction, we will inject enamel matrix derivative (EMDOGAIN 0.3ml) between femoral and tibial bone tunnel and graft. For postoperative 2 years, we will evaluate clinical and radiographic result.
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

Not applicable
Gender Male and Female
Key inclusion criteria the patient planed anterior cruciate ligament reconstruction
the patient obtained written informed consent
the patient who can visit a Hiroshima University hospital for treatment for two years
Key exclusion criteria the patient who apply the contraindication of EMDOGAIN
the patient who cannot obtaine written informed consent and had consciousness disorder or disorientation
the general condition of the patient is considerably bad
the patient with a serious liver damage
the patient with a serious renal damage
the female patient with the possibility with during the pregnancy or pregnancy
the female patient under the nursing
the patient with the past when is allergic to EMDOGAIN
the patient who had perfomed the operation of the knee
in addition, the patient who was disqualified by the chief physician for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mitsuo
Middle name
Last name Ochi
Organization Hiroshima University Hospital
Division name Department of orthopaedic surgery
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5233
Email seikei@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Kobun
Middle name
Last name Takazawa
Organization Hiroshima University Hospital
Division name Department of orthopaedic surgery
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5233
Homepage URL
Email kobuntakazawa@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center for Integrated Medial Reserch
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
Tel 082-257-1725
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
2014 Year 10 Month 30 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 17
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason We are making the last report.
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
2014 Year 07 Month 15 Day
Date of IRB
2014 Year 07 Month 15 Day
Anticipated trial start date
2014 Year 10 Month 30 Day
Last follow-up date
2018 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
2014 Year 10 Month 22 Day
Last modified on
2019 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016572

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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