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Recruitment status Completed
Unique ID issued by UMIN UMIN000011501
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email

Sponsor
Institute Chiba University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013163


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