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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016127
Receipt No. R000018714
Scientific Title A novel and minimally invasive surgery termed Percutaneous-transpedicular Injection of Polymethylmethacrylate into the Intervertebral vacuum space (PIPI) for chronic and disabling low back pain associated with de novo degenerative lumbar scoliosis in the elderly: a prospective single-center cohort study
Date of disclosure of the study information 2015/01/06
Last modified on 2015/01/06

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Basic information
Public title A novel and minimally invasive surgery termed Percutaneous-transpedicular Injection of Polymethylmethacrylate into the Intervertebral vacuum space (PIPI) for chronic and disabling low back pain associated with de novo degenerative lumbar scoliosis in the elderly: a prospective single-center cohort study
Acronym Prospective cohort study of a targeted operative therapy for low back pain associated with de novo degenerative lumbar scoliosis in the elderly.
Scientific Title A novel and minimally invasive surgery termed Percutaneous-transpedicular Injection of Polymethylmethacrylate into the Intervertebral vacuum space (PIPI) for chronic and disabling low back pain associated with de novo degenerative lumbar scoliosis in the elderly: a prospective single-center cohort study
Scientific Title:Acronym Prospective cohort study of a targeted operative therapy for low back pain associated with de novo degenerative lumbar scoliosis in the elderly.
Region
Japan

Condition
Condition Degenerative lumbar scoliosis
Classification by specialty
Geriatrics Orthopedics Radiology
Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of PIPI as a treatment for low back pain in elderly patients with degenerative lumbar scoliosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Visual analogue scale (VAS) for low back pain
2) Oswestry disability index
3) Bone marrow edema on MRI
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 PIPI
Interventions/Control_2 Non-operative treatment
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) De novo degenerative lumbar scoliosis with a Cobb angle >=10 degrees
2) Degenerative lumbar scoliosis patients aged >=65 years
3) Low back pain (LBP) lasted for >6 months with an intensity of VAS >50 points on a 0 to 100-point visual analogue scale (VAS), with 0 and 100 denoting no and maximal pain, respectively
4) Intervertebral vacuum phenomenon on coronal reconstructed CT
5) Vertebral bone marrow edema on coronal gadolinium-contrasted T1- or T2-weighed fat-saturated images
6) Locations of bone marrow edema in the spine consistent with those of lumbar tender points
Key exclusion criteria 1) Osteoporosis or lumbar vertebral density <70% of that of the young adult mean as determined by dual-energy x-ray absorptiometry
2) Infectious disease
3) Tumorous conditions of the spine
4) History of lumbar surgery
5) Leg length discrepancy due to hip or knee joint disease
6) LBP alleviated by facet joint anesthetic injections
7) Disoriented or did not complete the screening questionnaire
Target sample size 162

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Fujimoto
Organization JA Hiroshima General Hospital
Division name Dept. of Orthopaedic Surgery
Zip code
Address 1-3-3 Jigozen, Hatsukaichi, Hiroshima, Japan
TEL +81-829-36-3111
Email skydog1018@m6.dion.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Fujimoto
Organization JA Hiroshima General Hospital
Division name Dept. of Orthopaedic Surgery
Zip code
Address 1-3-3 Jigozen, Hatsukaichi, Hiroshima, Japan
TEL +81-829-36-311
Homepage URL
Email skydog1018@m6.dion.ne.jp

Sponsor
Institute JA Hiroshima General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 JA広島総合病院 (広島県)
JA Hiroshima General Hospital (Hiroshima)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 06 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
1) The immediate and substantial relief of low back pain has been achieved after PIPI for at least two years.
2) Non-operative treatment had no efficacy on the treatment of low back pain.
3) Bone marrow edema significantly improved in the PIPI group but not in the non-operative group.
4) The degree of bone marrow edema was correlated with the strength of VAS and the degree of ODI.
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
2000 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2000 Year 08 Month 01 Day
Last follow-up date
2013 Year 07 Month 31 Day
Date of closure to data entry
2014 Year 07 Month 31 Day
Date trial data considered complete
2014 Year 07 Month 31 Day
Date analysis concluded
2014 Year 07 Month 31 Day

Other
Other related information There were no major complications except for PMMA leakage into the foramen in 1 patient (1%).

Management information
Registered date
2015 Year 01 Month 06 Day
Last modified on
2015 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018714

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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