UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016127
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

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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 or person

Institute

JA Hiroshima General Hospital

Institute

Department

Personal name



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

Value
https://center6.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