UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011829 |
|---|---|
| Receipt number | 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 10:52:19 |
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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
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
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, 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013827
