UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016585 |
|---|---|
| Receipt number | R000015579 |
| Scientific Title | The Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: a double-blind randomized trial |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2015/02/12 09:28:46 |
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Basic information
Public title
The Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: a double-blind randomized trial
Acronym
The Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis
Scientific Title
The Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: a double-blind randomized trial
Scientific Title:Acronym
The Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis
Region
| Japan |
Condition
Condition
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of platelet-rich plasma in the treatment of knee osteoarthritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Japanese Knee Osteoarthritis Measure(JKOM)
Key secondary outcomes
The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Visualized Analog Scare(VAS)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Platelet rich plasma
Interventions/Control_2
Platelet poor plasma
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic knee pain (more than 3 months)Kellgren-Lawrence grade 1 to 4
Informed consent
VAS more than 30mm
No NSAIDs or steroid treatment in last 3 months
Key exclusion criteria
systemic or inflammatory joint diseases, haematological diseases, infections, Cancer/malignant lesions, surgical treatment within 6 months of inclusion, intra-articular pharmacological trtreatment within 3 months of inclusion, pregnancy, alcohol/drug abuse, Difficulties in comprehension and/or reading and writing, Physical impediments to answer questionnaire, poor general health as judged by the orthopaedic surgeon
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitomo Saita |
Organization
Juntendo university
Division name
Orthopaedics
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
ysaita@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitomo Saita |
Organization
Juntendo University
Division name
Orhopaedics
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
ysaita@juntendo.ac.jp
Sponsor or person
Institute
Department of orthopaedics, Juntendo university
Institute
Department
Personal name
Funding Source
Organization
Department of orthopaedics, Juntendo university
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
順天堂大学付属順天堂医院（Juntendo University Hospital）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | 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
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | 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
| 2015 | Year | 02 | Month | 20 | Day |
Last modified on
| 2015 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015579
