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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014694
Receipt No. 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

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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
Email 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
Email cindy.forever911@tsukuba-seikei.jp

Sponsor
Institute University of tsukuba
Department of Orthopaedic Surgery
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017021

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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