UMIN-CTR Clinical Trial

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 Masashi Middle name Last name Yamazaki
Organization	University of Tsukuba
Division name	Department of Orthopaedic Surgery, Faculty of Medicine
Zip code	3058575
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 Tomokazu Middle name Last name Yoshioka
Organization	University of Tsukuba
Division name	Div. of Regenerative Med. for Musculoskeletal System, Dep. of Orthop. Surgery, Faculty of Medicine
Zip code	3058575
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	The Japanese Association for the Promotion of State-of-the-Art in Medicine
Address	13-8 Takamine-cho, Showa-ku Nagoya-shi, Aichi 466-1811, Japan
Tel	052-745-6881
Email	tokutei-nintei@japsam.or.jp

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	Open public recruiting
Date of protocol fixation	2018 Year 10 Month 31 Day
Date of IRB	2018 Year 01 Month 25 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2022 Year 04 Month 30 Day
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	2019 Year 10 Month 22 Day

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