UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028601 |
|---|---|
| Receipt number | 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 14:51:17 |
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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
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
y-satoshi@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032735
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