UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005003 |
|---|---|
| Receipt number | R000005949 |
| Scientific Title | New anterior cruciate ligament reconstruction of reaming bone tunnel from the joint using a new drill guide pin. |
| Date of disclosure of the study information | 2011/02/02 |
| Last modified on | 2011/02/02 14:14:38 |
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Basic information
Public title
New anterior cruciate ligament reconstruction of reaming bone tunnel from the joint using a new drill guide pin.
Acronym
New intra-articular anterior cruciate ligament reconstruction
Scientific Title
New anterior cruciate ligament reconstruction of reaming bone tunnel from the joint using a new drill guide pin.
Scientific Title:Acronym
New intra-articular 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
to evaluate the new less invasive and effective procedure of ACL
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
assessment of stability and radiographic evaluation of bone tunnel in the knee
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
clinical application of this new surgical treatment
Interventions/Control_2
conventional method of surgical treratment
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients of ACL injury
Key exclusion criteria
no agreement of the informed consent of this new procedure
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Takahashi |
Organization
Ehime University Hospital
Division name
orthopaedic surgery
Zip code
Address
shitukawa, toon, ehime, japan
TEL
089-960-5343
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Takahashi |
Organization
orthopaedic surgery
Division name
Ehime university hospital
Zip code
Address
shitukawa, toon, ehime, japan
TEL
089-960-5343
Homepage URL
takahast@m.ehime-u.ac.jp
Sponsor or person
Institute
Dept. of Bone and Joint Surg. Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dept. of Bone and Joint Surg. Ehime University Graduate School of Medicine
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
| 2011 | Year | 02 | Month | 02 | 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
Results
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 02 | Day |
Last modified on
| 2011 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005949
