UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007285 |
|---|---|
| Receipt number | R000005519 |
| Scientific Title | Clinical trial of new therapy for anterior cruciate ligament reconstruction with the use of autologous injured tissue |
| Date of disclosure of the study information | 2012/02/13 |
| Last modified on | 2014/03/23 23:01:03 |
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Basic information
Public title
Clinical trial of new therapy for anterior cruciate ligament reconstruction with the use of autologous injured tissue
Acronym
Anterior cruciate ligament reconstruction with the use of autologous injured tissue
Scientific Title
Clinical trial of new therapy for anterior cruciate ligament reconstruction with the use of autologous injured tissue
Scientific Title:Acronym
Anterior cruciate ligament reconstruction with the use of autologous injured tissue
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigatesafty and effectiveness of anterior cruciate ligament reconstruction with the use of autologous injured tissue for anterior cruciate ligament injury
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Clinical outcom at 3, 6, and 12 months after surgery (Lysholm score)
Key secondary outcomes
Computer tomography at 6 and 12 months after surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
anterior cruciate ligament reconstruction
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) anterior cruciate ligament injury diagnosed by physical examination and magnetic resonance image
2) injury within 3 months
3) isolated injury
4) Informed consent by writing
Key exclusion criteria
1) Patients receiving radiation, chemotherapy, immunosuppression, or chronic steroids
2) Patients with complete neuropathy that would interfere with walking or appreciation of pain
3) 4000<WBC<10000
4) Patients with active infection systemically or at the site of knee
5) Patients joining in another clinical study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryosuke Kuroda |
Organization
Kobe University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5985
kurodar@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Matsumoto |
Organization
Kobe University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5985
Homepage URL
matsun@m4.dion.ne.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
not applicable
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
Address
Tel
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
| 2012 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24582053
Number of participants that the trial has enrolled
Results
Ten patients were devided into two group. One is the tissue group, in which double bundle anterior-cruciate regament reconstruction (DB-ACLR) was performed with ruptured tissue and the other is the control group, in which DB-ACLR was performed without tissue. Clinical outcomes including Lysholm score, anteroposterior stability by KT-1000, and rotational stability by pivot shift test showed no significant differences between the two groups. However, especially at the femoral side, reduction of tunnel enlargement was significantly found in the tissue group compred with the control group.
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
| 2011 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | 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
| 2012 | Year | 02 | Month | 13 | Day |
Last modified on
| 2014 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005519
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
