UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010069 |
|---|---|
| Receipt number | R000011792 |
| Scientific Title | Postoperative Intramuscular Pressure of the Multifidus Muscle and Low Back Pain: A Randomized Study Comparing Mini-open with Conventional Posterior Lumbar Interbody Fusion |
| Date of disclosure of the study information | 2013/02/18 |
| Last modified on | 2013/02/18 20:59:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Postoperative Intramuscular Pressure of the Multifidus Muscle and Low Back Pain: A Randomized Study Comparing Mini-open with Conventional Posterior Lumbar Interbody Fusion
Acronym
Postoperative Intramuscular Pressure and Low Back Pain after PLIF
Scientific Title
Postoperative Intramuscular Pressure of the Multifidus Muscle and Low Back Pain: A Randomized Study Comparing Mini-open with Conventional Posterior Lumbar Interbody Fusion
Scientific Title:Acronym
Postoperative Intramuscular Pressure and Low Back Pain after PLIF
Region
| Japan |
Condition
Condition
spondylolisthesis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the route of pedicle screw insertion affects the intramuscular pressure and low back pain after PLIF
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative intramuscular pressure, Postoperative low back pain
The pressure is measured five times (30 minutes, 6, 12, 24, and 48 hours after surgery).
The assessment of low back pain is performed before surgery and after surgery (2 weeks, 1 month, 3 months, 6 months, and 12 months).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Mini-open PLIF
Interventions/Control_2
Conventional PLIF
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
spondylolisthesis at the single level of L4-L5
absence of associated lumbar lesions at a level other than L4-L5
failure of conservative therapy for several months
Key exclusion criteria
scoliosis,
isthmic spondylolisthesis,
rheumatoid arthritis,
dialysis-related spondyloarthropathy,
infection, or tumors
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Mukai |
Organization
Osaka Kosei-nenkin Hospital
Division name
Department of Orthopedic Surgery
Zip code
Address
4-2-78, Fukushima, Osaka 553-0003, Japan
TEL
06-6441-5451
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Mukai |
Organization
Osaka Kosei-nenkin Hospital
Division name
Department of Orthopedic Surgery
Zip code
Address
4-2-78, Fukushima, Osaka 553-0003, Japan
TEL
Homepage URL
Sponsor or person
Institute
Osaka Kosei-nenkin 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
大阪厚生年金病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 18 | 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
| 2007 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
| 2012 | Year | 01 | Month | 25 | Day |
Date trial data considered complete
| 2012 | Year | 01 | Month | 25 | Day |
Date analysis concluded
| 2012 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 18 | Day |
Last modified on
| 2013 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011792
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
