Unique ID issued by UMIN | UMIN000016127 |
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Receipt number | 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 10:25:45 |
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
Prospective cohort study of a targeted operative therapy for low back pain associated with de novo degenerative lumbar scoliosis in the elderly.
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
Prospective cohort study of a targeted operative therapy for low back pain associated with de novo degenerative lumbar scoliosis in the elderly.
Japan |
Degenerative lumbar scoliosis
Geriatrics | Orthopedics | Radiology |
Operative medicine |
Others
NO
To examine the efficacy and safety of PIPI as a treatment for low back pain in elderly patients with degenerative lumbar scoliosis
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
1) Visual analogue scale (VAS) for low back pain
2) Oswestry disability index
3) Bone marrow edema on MRI
Parallel
Non-randomized
Open -but assessor(s) are blinded
Active
2
Treatment
Maneuver | Other |
PIPI
Non-operative treatment
65 | years-old | <= |
Not applicable |
Male and Female
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
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
162
1st name | |
Middle name | |
Last name | Yoshinori Fujimoto |
JA Hiroshima General Hospital
Dept. of Orthopaedic Surgery
1-3-3 Jigozen, Hatsukaichi, Hiroshima, Japan
+81-829-36-3111
skydog1018@m6.dion.ne.jp
1st name | |
Middle name | |
Last name | Yoshinori Fujimoto |
JA Hiroshima General Hospital
Dept. of Orthopaedic Surgery
1-3-3 Jigozen, Hatsukaichi, Hiroshima, Japan
+81-829-36-311
skydog1018@m6.dion.ne.jp
JA Hiroshima General Hospital
None
Self funding
None
None
None
NO
JA広島総合病院 (広島県)
JA Hiroshima General Hospital (Hiroshima)
2015 | Year | 01 | Month | 06 | Day |
Unpublished
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.
Completed
2000 | Year | 07 | Month | 31 | Day |
2000 | Year | 08 | Month | 01 | Day |
2013 | Year | 07 | Month | 31 | Day |
2014 | Year | 07 | Month | 31 | Day |
2014 | Year | 07 | Month | 31 | Day |
2014 | Year | 07 | Month | 31 | Day |
There were no major complications except for PMMA leakage into the foramen in 1 patient (1%).
2015 | Year | 01 | Month | 06 | Day |
2015 | Year | 01 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018714
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