UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025287 |
|---|---|
| Receipt number | R000028002 |
| Scientific Title | The effect of remnant preservation or synovial patch to cover the graft on clinical outcomes in double-bundle anterior cruciate ligament reconstruction: A prospective randomized controlled trial |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2016/12/15 14:01:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of remnant preservation or synovial patch to cover the graft on clinical outcomes in double-bundle anterior cruciate ligament reconstruction: A prospective randomized controlled trial
Acronym
Orthopedic Surgery, Tokyo Medical and Dental University Hospital
Scientific Title
The effect of remnant preservation or synovial patch to cover the graft on clinical outcomes in double-bundle anterior cruciate ligament reconstruction: A prospective randomized controlled trial
Scientific Title:Acronym
Orthopedic Surgery, Tokyo Medical and Dental University Hospital
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate the effect of remnant preservation or synovial patch to cover the graft on clinical outcomes in double-bundle anterior cruciate ligament reconstruction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stability of the knee joint
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ACL volume remain equal to or more than 50 %:
ACL reconstruction without remnant preservation
Interventions/Control_2
ACL volume remain equal to or more than 50 %:
ACL reconstruction with remnant preservation
Interventions/Control_3
ACL volume remain less than 50 %:
ACL reconstruction without remnant preservation
Interventions/Control_4
ACL volume remain less than 50 %:
ACL reconstruction with remnant preservation and synovial patch
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
Primary ACL reconstruction with double-bundlehhamstring tendon graft
Key exclusion criteria
ACL reconstruction with any grafts except for hamstring tendon, bilateral ACL-injury, multiple ligament injury, past injured/surgical history of the knee
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Horie |
Organization
Tokyo Medical and Dental University
Division name
Center for stem cell and regenerative medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4775
horie.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Horie |
Organization
Tokyo Medical and Dental University
Division name
Center for stem cell and regenerative medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4775
Homepage URL
horie.orj@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | 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
| 2016 | Year | 12 | Month | 15 | Day |
Last modified on
| 2016 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028002
