UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical studies on the safety and efficacy of platelet rich plasma used in anterior cruciate ligament reconstruction
Title of the study (Brief title)	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	Akihiro Kanamori
Organization	Medicine Medical
Division name	Orthopaedic Surgery
Address	1-1-1 Tennodai,Ibaraki,JAPAN
TEL	029-853-3219
Email	kanamori@md.tsukuba.ac.jp

Public contact
Name of contact person	YU TANIGUCHI
Organization	Univercity of Tsukuba
Division name	Orthopaedic surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017021