UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007833 |
|---|---|
| Receipt number | R000009145 |
| Scientific Title | A prospective randomized controlled trial comparing unilateral pedicle screw versus bilateral pedicle screw in transforaminal lumbar interbody fusion for degenerative spondylolisthesis. |
| Date of disclosure of the study information | 2012/04/25 |
| Last modified on | 2012/05/02 22:49:18 |
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Basic information
Public title
A prospective randomized controlled trial comparing unilateral pedicle screw versus bilateral pedicle screw in transforaminal lumbar interbody fusion for degenerative spondylolisthesis.
Acronym
A prospective randomized controlled trial comparing unilateral pedicle screw versus bilateral pedicle screw in transforaminal lumbar interbody fusion.
Scientific Title
A prospective randomized controlled trial comparing unilateral pedicle screw versus bilateral pedicle screw in transforaminal lumbar interbody fusion for degenerative spondylolisthesis.
Scientific Title:Acronym
A prospective randomized controlled trial comparing unilateral pedicle screw versus bilateral pedicle screw in transforaminal lumbar interbody fusion.
Region
| Japan |
Condition
Condition
Lumbar degenerative spondylolisthesis.
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze surgical outcomes of lumbar interbody fusion using unilateral pedicle screw compared to bilateral pedicle screw.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Surgical invasiveness and postoperative pain
Key secondary outcomes
Surgical time
Intraoperative bleeding
Post-operative pain (visual analogue scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Transforaminal lumbar interbody fusion with unilateral pedicle screw
Interventions/Control_2
Transforaminal lumbar interbody fusion with bilateral pedicle screw
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for one-level TLIF for lumbar degenerative spondylolisthesis
Key exclusion criteria
Patients who show isthmic spondylolisthesis, vertebral fractures, tumors, or infectious diseases.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuchika Aoki |
Organization
Chiba Rosai Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-16 Tatsumidai-higashi, Ichihara, Chiba, 290-0003, Japan
TEL
0436-74-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba Rosai Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-16 Tatsumidai-higashi, Ichihara, Chiba, 290-0003, Japan
TEL
Homepage URL
Sponsor or person
Institute
Chiba Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 25 | 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
Patients treated with lumbar interbody fusion with unilateral pedicle screw showed significantly shorter surgical time and lower blood loss, and showed significantly less improvement in VAS for lower-extremity pain.
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
| 2006 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 25 | Day |
Last modified on
| 2012 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009145
