UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015497 |
|---|---|
| Receipt number | 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 | 2023/05/24 17:26:06 |
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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
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
kobuntakazawa@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10085527/pdf/cureus-0015-00000035960.pdf
Number of participants that the trial has enrolled
19
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It took a long time to prepare the final report.
Date of the first journal publication of results
| 2023 | Year | 04 | Month | 14 | Day |
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
| 2023 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016572
