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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010069
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Osaka Kosei-nenkin Hospital
Institute
Department

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 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
URL(English) https://upload.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


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