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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011829
Receipt No. R000013827
Scientific Title Safety and efficacy of intra-articular injections of platelet-rich plasma for the treatment of osteoarthritis of the knee in the Japanese population
Date of disclosure of the study information 2013/10/01
Last modified on 2015/11/18

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Basic information
Public title Safety and efficacy of intra-articular injections of platelet-rich plasma for the treatment of osteoarthritis of the knee in the Japanese population
Acronym Safety of platelet-rich plasma for the treatment of osteoarthritis of the knee
Scientific Title Safety and efficacy of intra-articular injections of platelet-rich plasma for the treatment of osteoarthritis of the knee in the Japanese population
Scientific Title:Acronym Safety of platelet-rich plasma for the treatment of osteoarthritis of the knee
Region
Japan

Condition
Condition Osteoarthritis of the knee
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of intra-articular injections of platelet-rich plasma for the treatment of osteoarthritis of the knee in the Japanese population.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Adverse events during the treatment and follow-up period.
1. Shock
2. Pain and stiffness
3. Swelling
4. Local heat
Key secondary outcomes 1. The percentage of patients having
a 50% decrease in the summed score for the Visual Analogue Scale from baseline to week 24.
2. Serum hyaluronic acid concentration rate before and after treatment
3. Improvement of felction and extension angle of the knee
4. Improvement rate of Japanese Knee Osteoarthritis Measure
5. Improvement of Japanese Orthopaedics Association score

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
Other
Interventions/Control_1 Intra-articlar injections of platelet-rich plasma derived from autologous peripheral blood
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
50 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1. With a history of chronic (for at least 3 months) knee joint pain more than 35-mm on 0- to 100-mm visual analogue scale
2. Radiographically documented grades 1-3 osteoarthritis of the knee, grade according to the Kellgren-Lawrence radiographic classification scale
3. BMI ranging between 20 and 32
4. Requiring infiltration in monolateral knee
5. Possibility for observation during follow-up period
Key exclusion criteria 1. Requiring infiltration in both knees
2. BMI more than 33
3. Suffering from polyarticular disease
4. Previous knee arthroscopy within last year
5. HA or steroid intra-articular infiltration within last 3 months
6. Past history of infectious disease
7. Compromised host
8. Systemic autoimmune disease
9. Anemia with hemoglobin under 10g/dl
10. Blood disorders
11. Treatment with anticoagulant drugs (Aspirin, Warfarin)
12. Having undergone treatment with steroids during 3 months before inclusion in this study
13. Treatment with NSAIDs during 2 weeks before its inclusion in this study
14. Patients who had malignancy during 5 years before inclusion in this study
15. Patients who do not have a voluntary consent capacity
16. Patients who cannot have a consent with document
17. Patients whom the doctor has determined that it is not suitable for this clinical study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Yamazaki
Organization University of Tsukuba
Division name Department of Orthopaedics Surgery, Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-3219
Email masashiy@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomokazu Yoshioka
Organization University of Tsukuba Hospital
Division name Department of Rehabilitation
Zip code
Address 2-1-1 Amakubo, Tsukuba, Ibaraki
TEL 029-853-3219
Homepage URL
Email yoshioka@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba Hospital
Institute
Department

Funding Source
Organization Department of Orthopaedics Surgery, Faculty of Medicine, University of Tsukuba
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
2013 Year 10 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
2013 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2015 Year 11 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 20 Day
Last modified on
2015 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013827

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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