UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011501 |
|---|---|
| Receipt number | R000013163 |
| Scientific Title | A randomized controlled trial of lumbar fusion in combination with platelet-rich plasma(PRP) |
| Date of disclosure of the study information | 2013/08/31 |
| Last modified on | 2013/08/16 16:08:21 |
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Basic information
Public title
A randomized controlled trial of lumbar fusion in combination with platelet-rich plasma(PRP)
Acronym
PRP (platelet-rich plasma ) SS (spine surgery) Project
Scientific Title
A randomized controlled trial of lumbar fusion in combination with platelet-rich plasma(PRP)
Scientific Title:Acronym
PRP (platelet-rich plasma ) SS (spine surgery) Project
Region
| Japan |
Condition
Condition
Lumbar Spinal Stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and complication of Platelet-Rich Plasma (PRP) on posterolateral lumbar fusion for bone fusion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone fusion
Complication
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
| Maneuver |
Interventions/Control_1
Implantation+ autologous bone or artificial bone
Interventions/Control_2
Implantation+ autologous bone or artificial bone+platelet-rich 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 50-80 years old patients
2)Patients had low back and leg pain, intermittent claudication .
3)Patients scheduled for one-two level posterolateral lumbar fusion for lumbar canalstenosiswith instability.
Key exclusion criteria
1)Disturbance of consciousness
2)Osteoporosis(YAM<60%)
3)History of spinal surgery
4)History of tumor
5)Heart,kidney,liver and respiratoryfailure
6)Diabetes(HbA1C<7.0)
7)Smoking
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Chiba University Hospital
Division name
Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba city, Chiba, Japan. 260-8670
TEL
043-226-2117
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Chiba University Hospital
Division name
Orthopaedic Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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 | 08 | Month | 31 | 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
| 2009 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | 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
| 2013 | Year | 08 | Month | 16 | Day |
Last modified on
| 2013 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013163
| 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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