UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015515 |
|---|---|
| Receipt number | R000018026 |
| Scientific Title | A randomized controlled trial of 3 approaches for femoral tunnel creation in anterior cruciate ligament reconstruction. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2023/10/30 09:25:32 |
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Basic information
Public title
A randomized controlled trial of 3 approaches for femoral tunnel creation in anterior cruciate ligament reconstruction.
Acronym
RCT of 3 approaches for femoral tunnel creation in ACLR.
Scientific Title
A randomized controlled trial of 3 approaches for femoral tunnel creation in anterior cruciate ligament reconstruction.
Scientific Title:Acronym
RCT of 3 approaches for femoral tunnel creation in ACLR.
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of clinical outcomes between 3 approaches of femoral tunnel creation in anterior cruciate ligament reconstruction.
Basic objectives2
Others
Basic objectives -Others
Comparison of clinical outcomes between existing 3 surgical techniques.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The knee functional evaluation and questionnaire assessment at preoperative and postoperative 12,24 months.
Key secondary outcomes
1) The knee functional evaluation at preoperative and postoperative 3,6,9,12,18,24 months.
2) Questionnaire assessment at preoperative and postoperative 6,12,18,24 months.
3) Duration of operation.
4) Femoral tunnel aperture position.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Femoral tunnel creation will be performed by transtibial technique.
Follow up: 24 months.
Interventions/Control_2
Femoral tunnel creation will be performed by transportal technique.
Follow up: 24 months.
Interventions/Control_3
Femoral tunnel creation will be performed by outside-in technique.
Follow up: 24 months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are planned to undergo double-bundle anterior cruciate ligament reconstruction using hamstrings.
Key exclusion criteria
1) Revision surgery
2) History of injuries in the ipsilateral knee
3) History of ligamentous injuries in the contralateral knee
4) Concomitant ligament tears
5) Severe limitation of range of motion of the knee
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Koga |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopaedic Surgery
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4020
koga.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tomomasa |
| Middle name | |
| Last name | Nakamura |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopaedic Surgery
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4775
Homepage URL
nakamura.orj@tmd.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Tokyo Medical and Dental University
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
Ethical committee, Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo Japan
Tel
03-5803-5096
syomu1.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1842
Org. issuing International ID_1
Faculty of Medicine, Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科歯科大学医学部附属病院（東京都)
Tokyo Medical and Dental University Hospital of Medicine
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 01 | 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
97
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Submitted manuscript has not been accepted yet.
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 23 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018026
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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