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 |
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
Platelet-rich plasma injections for the patients with osteoarthritis of the knee in the Japanese population
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
Platelet-rich plasma injections for the patients with osteoarthritis of the knee in the Japanese population
Japan |
Osteoarthritis of the knee
Orthopedics |
Others
NO
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
Efficacy
Confirmatory
Pragmatic
Phase II,III
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
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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is considered as a block.
Central registration
2
Treatment
Other |
Intra-articlar injections: Platelet-rich plasma derived from autologous peripheral blood
Intra-articlar injections: Saline
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
30
1st name | Masashi |
Middle name | |
Last name | Yamazaki |
University of Tsukuba
Department of Orthopaedic Surgery, Faculty of Medicine
3058575
1-1-1 Tennodai, Tsukuba, Ibaraki
029-853-3219
masashiy@md.tsukuba.ac.jp
1st name | Tomokazu |
Middle name | |
Last name | Yoshioka |
University of Tsukuba
Div. of Regenerative Med. for Musculoskeletal System, Dep. of Orthop. Surgery, Faculty of Medicine
3058575
1-1-1 Tennodai, Tsukuba, Ibaraki
029-853-3219
yoshioka@md.tsukuba.ac.jp
University of Tsukuba Hospital
Department of Orthopaedics Surgery, Faculty of Medicine
Self funding
The Japanese Association for the Promotion of State-of-the-Art in Medicine
13-8 Takamine-cho, Showa-ku Nagoya-shi, Aichi 466-1811, Japan
052-745-6881
tokutei-nintei@japsam.or.jp
NO
2018 | Year | 11 | Month | 01 | Day |
Unpublished
Open public recruiting
2018 | Year | 10 | Month | 31 | Day |
2018 | Year | 01 | Month | 25 | Day |
2018 | Year | 11 | Month | 01 | Day |
2022 | Year | 04 | Month | 30 | Day |
2018 | Year | 10 | Month | 16 | Day |
2019 | Year | 10 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036865