UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034517 |
|---|---|
| Receipt number | 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 | 2019/10/22 17:02:00 |
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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 | 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
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
yoshioka@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036865
