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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028601
Receipt No. R000032735
Scientific Title Safety and efficacy of intra-articular injection of platelet rich plasma in patients with ankle osteoarthritis
Date of disclosure of the study information 2017/08/10
Last modified on 2017/08/09

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Basic information
Public title Safety and efficacy of intra-articular injection of platelet rich plasma in patients with ankle osteoarthritis
Acronym Platelet-rich Plasma in patients with ankle osteoarthritis
Scientific Title Safety and efficacy of intra-articular injection of platelet rich plasma in patients with ankle osteoarthritis
Scientific Title:Acronym 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
1st name
Middle name
Last name Takahisa Sasho
Organization Graduate School of Medicine, Chiba University
Division name Department of Orthopaedic Surgery
Zip code
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
1st name
Middle name
Last name Satoshi Yamaguchi
Organization Graduate School of Medicine, Chiba University
Division name Department of Orthopaedic Surgery
Zip code
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)

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
2017 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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
2013 Year 04 Month 09 Day
Date of IRB
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

Other
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

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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