UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of intra-articular injection of platelet rich plasma in patients with ankle osteoarthritis
Title of the study (Brief title)	Platelet-rich Plasma in patients with ankle osteoarthritis
Region	Japan

Condition
Condition	Ankle osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the safety and efficacy of intra-articular injection of platelet-rich plasma in patients with ankle osteoarthritis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse events, including infection, local swelling, and redness after injection and the follow-up visits at 4, 12, 24 weeks after the last injection
Key secondary outcomes	Clinical evaluations (visual analogue scale for pain, JSSF scale, SAFE-Q) at 1 week before the first injection and at 4, 12, and 24 weeks after the last injection.

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	Maneuver
Interventions/Control_1	Intra-articular injection of platelet-rich plasma into the ankle joint 2 ml per injection 3 injections with 2-week intervals.
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Age of 20-80 years 2 Ankle pain for more than 6 months 3 Radiological diagnosis of ankle osteoarthritis 4 Not responsive to conservative treatment for at least 6 months 5 Pain visual analogue scale of 4 or more 6 Informed consent provided
Key exclusion criteria	1 Anemia (hemoglobin levels less than 11mg/dl) 2 Thrombocytopenia (platelet levels less than 150*103/ul) 3 History of ankle surgery or ankle fracture within the past 12 months 4 Treatment with steroid or hyaluronic acid injections within the past 6 months 5 Treatment with oral anticoagulant 6 Systemic inflammatory disease (eg rheumatoid arthritis) 7 Renal failure 8 Hepatic failure 9 Diabetes mellitus (HbA1c more than 9.0) 10 Psychological disease 11 Pregnancy 12 Infection of the ankle 13 Cancer or malignant lesions
Target sample size	20

Research contact person
Name of lead principal investigator	Takahisa Sasho
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Orthopaedic Surgery
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-226-2117
Email	sasho@faculty.chiba-u.jp

Public contact
Name of contact person	Satoshi Yamaguchi
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Orthopaedic Surgery
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-226-2117
Homepage URL
Email	y-satoshi@faculty.chiba-u.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Chiba Foundation for Health Promotion & Disease Prevention
Organization
Division
Category of Funding Organization	Non profit foundation
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	2017 Year 08 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 09 Day
Anticipated trial start date	2013 Year 06 Month 25 Day
Last follow-up date	2015 Year 06 Month 26 Day
Date of closure to data entry	2015 Year 06 Month 30 Day
Date trial data considered complete	2016 Year 06 Month 30 Day
Date analysis concluded	2016 Year 09 Month 19 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	No serious adverse effects were observed related with intra-articular injection of platelet rich plasma. The VAS scores significantly decreased from baseline to 4, 12, and 24 weeks after treatment. The JSSF scale score and the pain and pain-related subscale score of the SAFE-Q significantly improved from baseline to 12 weeks after treatment.
Other related information

Management information
Registered date	2017 Year 08 Month 09 Day
Last modified on	2017 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032735