UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014694 |
|---|---|
| Receipt number | R000017021 |
| Scientific Title | Clinical studies on the safety and efficacy of platelet rich plasma used in anterior cruciate ligament reconstruction |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2017/07/31 10:07:46 |
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Basic information
Public title
Clinical studies on the safety and efficacy of platelet rich plasma used in anterior cruciate ligament reconstruction
Acronym
Clinical studies on the safety and efficacy of platelet rich plasma used in anterior cruciate ligament reconstruction
Scientific Title
Clinical studies on the safety and efficacy of platelet rich plasma used in anterior cruciate ligament reconstruction
Scientific Title:Acronym
Clinical studies on the safety and efficacy of platelet rich plasma used in anterior cruciate ligament reconstruction
Region
| Japan |
Condition
Condition
rupture of anterior cruciate ligament
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety of PRP use in ACL reconstruction
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The presence or absence of adverse events in the follow-up period and at the time of surgery
1.Change in the vital signs when it is inserted into the intra-articular ligament with PRP
2.Joint fluid culture of postoperative drain effluent
3.Swelling of knee joint during follow-up times
4.Infection sign during 2weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Use of PRP to the ACL reconstruction patients
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
| 16 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients operated ACL reconstruction in our hospital
Key exclusion criteria
History of infection(septic arthritis of the knee, femur / tibia osteomyelitis) /
compromised host (Child-Pugh score A-C, diabetes, immunodeficiency, chronic renal failure, cirrhosis of the liver) - autoimmune disease(Various collagen diseases such as rheumatoid arthritis, systemic lupus erythematosus)
Anemia (hemoglobin 10 g / dl or less) Blood disease(Coagulation and fibrinolysis abnormalities such as hemophilia) Anticoagulant used (such as aspirin, warfarin)
Patients with a suspected history of malignancy within 5 years prior to the date of consent
Patients who study physician determines that it is not suitable as a target
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Kanamori |
Organization
Medicine Medical
Division name
Orthopaedic Surgery
Zip code
Address
1-1-1 Tennodai,Ibaraki,JAPAN
TEL
029-853-3219
kanamori@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YU TANIGUCHI |
Organization
Univercity of Tsukuba
Division name
Orthopaedic surgery
Zip code
Address
1-1-1 Tennodai,Ibaraki,JAPAN
TEL
029-853-3219
Homepage URL
cindy.forever911@tsukuba-seikei.jp
Sponsor or person
Institute
University of tsukuba
Department of Orthopaedic Surgery
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
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
| 2014 | Year | 08 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 29 | Day |
Last modified on
| 2017 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017021
