UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016058 |
|---|---|
| Receipt number | R000018661 |
| Scientific Title | Clinical trial of lumbar fusion in combination with platelet rich plasma(PRP) and allograft. |
| Date of disclosure of the study information | 2014/12/26 |
| Last modified on | 2014/12/26 00:14:17 |
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Basic information
Public title
Clinical trial of lumbar fusion in combination with platelet rich plasma(PRP) and allograft.
Acronym
Clinical trial of lumbar fusion in combination with PRP and allograft.
Scientific Title
Clinical trial of lumbar fusion in combination with platelet rich plasma(PRP) and allograft.
Scientific Title:Acronym
Clinical trial of lumbar fusion in combination with PRP and allograft.
Region
| Japan |
Condition
Condition
lumbar stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the safety of PRP and allograft
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse event
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
allograft
Interventions/Control_2
PRP+allograft
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
| 55 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. age 55-85
2. symptom:low back pain,leg pain,intermittent claudication
3.finding from study of images conforming clinical symptom
4.spinal instability
5.non-effective conservative therapy more than three months
Key exclusion criteria
1. severe systemic complication for example, heart failure,renal failure, liver failure, respiratory failure
2.anamnesis of AMI and cardiac hypofunction
3.complication of severe angina
4.severe renal function failure
5..severe lever function failure
6.respiratory functional failure
7.diabetes more than HbA1c9.0
8.psycological complication
9.pregnancy
10.hypersensitivity for thrombin
11.cardiac stimulation medication
hypercalcemia
12.inadequate patients
13.disturbance of consciousness
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takahashi |
Organization
Graduate school of medicine chiba univresity
Division name
Orthpedic
Zip code
Address
1-8-1 inohana chuuouku chibashi chibakenn Japan
TEL
043-222-7171
19501114@faculity.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Graduate school of medicine chiba univresity
Division name
Orthpedic
Zip code
Address
1-8-1 inohana chuuouku chibashi chibakenn Japan
TEL
043-222-7171
Homepage URL
sohtori@faculty.chiba-u.jp
Sponsor or person
Institute
Graduate school of medicine chiba univresity
Institute
Department
Personal name
Funding Source
Organization
Lilly Grand Office
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2014 | Year | 12 | Month | 26 | 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
| 2014 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 26 | 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
| 2014 | Year | 12 | Month | 26 | Day |
Last modified on
| 2014 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018661
| 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 |
