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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034517
Receipt No. R000036865
Scientific Title Intra-articular platelet-rich plasma injections for the patients with osteoarthritis of the knee in the Japanese population: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
Date of disclosure of the study information 2018/11/01
Last modified on 2018/11/07

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Basic information
Public title Intra-articular platelet-rich plasma injections for the patients with osteoarthritis of the knee in the Japanese population: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
Acronym Platelet-rich plasma injections for the patients with osteoarthritis of the knee in the Japanese population
Scientific Title Intra-articular platelet-rich plasma injections for the patients with osteoarthritis of the knee in the Japanese population: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
Scientific Title:Acronym Platelet-rich plasma injections for the patients with osteoarthritis of the knee in the Japanese population
Region
Japan

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

Objectives
Narrative objectives1 To compare the effectiveness of intra-articular platelet-rich plasma injections with intra-articular saline injection as a placebo for the patients with osteoarthritis of the knee
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes The improvement rate of WOMAC (Western Ontario and McMaster Universities Osteoarthritis) score in comparison between 24 weeks after the start of treatment and before treatment
Key secondary outcomes 1. Visual Analogue Scale for pain after 24 weeks from the start of treatment (at the time of the first injection)
2. The improvement rate of MRI Osteoarthritis Knee Score (MOAKS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Intra-articlar injections: Platelet-rich plasma derived from autologous peripheral blood
Interventions/Control_2 Intra-articlar injections: Saline
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. 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. With hydrarthrosis or bone marrow lesion or synovitis
4. Requiring infiltration in monolateral knee
5. Possibility for observation during follow-up period
Key exclusion criteria 1. BMI less than 18.5
2. BMI more than 25
3. Suffering from polyarticular disease
4. Valgus knee and varus knee more than 10 degree in X-ray
5. Previous knee arthroscopy within 6 months
6. HA or steroid intra-articular infiltration within last 1 month
7. Past history of infectious disease
8. Skin disease in knee
9. Compromised host
10. Systemic autoimmune disease
11. Anemia with hemoglobin under 9.0 g/dl
12. Blood disorders
13. Treatment with anticoagulant drugs (Aspirin, Warfarin)
14. Having undergone treatment with steroids during 3 months before inclusion in this study
15. Treatment with NSAIDs during 2 weeks before its inclusion in this study
16. Patients who had malignancy during 5 years before inclusion in this study
17. Patients who cannot have a consent with document
18. Patients whom the doctor has determined that it is not suitable for this clinical study
Target sample size 30

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
Division name Div. of Regenerative Med. for Musculoskeletal System, Dep. of Orthop. Surgery, Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, 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
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
2018 Year 11 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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 16 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036865

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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