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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007285
Receipt No. 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

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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
Email 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
Email matsun@m4.dion.ne.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005519

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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