UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007284 |
|---|---|
| Receipt number | R000002835 |
| Scientific Title | Therapeutic strategy of chomposite of Platelet-Rich Plasma (PRP) and hydrogel for meniscal repair |
| Date of disclosure of the study information | 2012/02/13 |
| Last modified on | 2014/09/16 15:55:27 |
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Basic information
Public title
Therapeutic strategy of chomposite of Platelet-Rich Plasma (PRP) and hydrogel for meniscal repair
Acronym
Therapeutic strategy of chomposite of PRP and hydrogel for meniscal repair
Scientific Title
Therapeutic strategy of chomposite of Platelet-Rich Plasma (PRP) and hydrogel for meniscal repair
Scientific Title:Acronym
Therapeutic strategy of chomposite of PRP and hydrogel for meniscal repair
Region
| Japan |
Condition
Condition
knee meniscal tear
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to perform ideal meniscal regeneration without meniscal resection using composite of PRP and hydrogel for meniscal tear.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of efficacy is whether injured meniscus is healed or not after 4 weeks after the treatment in MRI findings.
Evaluation of safety is all harmful issues occurred during the study.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
meniscal repair
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
| 16 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Meniscal tear diagnosed by physical examination and magnetic resonance image
2) 1. Longitudinal and vertical (bucket-handle) tear in or near vascular zone: meniscal repair and transplantation of PRP and hydrogel
2. meniscal tear except for the above: intra-articular injection of PRP
3) Informed consent by writing
Key exclusion criteria
1) Patients receiving radiation, chemotherapy, immunosuppression, or chronic steroids
2) Patients with complete neuropathy that would interfere with walking or appreciation of pain
3) Patients with known sensitivity to gelatin
4) Patients with active infection systemically or at the site of knee
5) Patients joining in another clinical study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryosuke Kuroda |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5985
kurodar@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Matsumoto |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5985
Homepage URL
matsun@m4.dion.ne.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 02 | Month | 13 | 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
The number of cases which need meniscal repair with PRP transplantation was limited, leading to terminate the study. As for safty evaluation, no sereous adverse event was found in the study.
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
Terminated
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 13 | Day |
Last modified on
| 2014 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002835
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
