UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022460 |
|---|---|
| Receipt number | R000025883 |
| Scientific Title | Controlled study of posterior decompression and posterior fusion for the lumbar degenerative spondylolisthesis |
| Date of disclosure of the study information | 2016/05/26 |
| Last modified on | 2019/03/29 01:24:58 |
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Basic information
Public title
Controlled study of posterior decompression and posterior fusion for the lumbar degenerative spondylolisthesis
Acronym
Controlled study of posterior decompression and posterior fusion for the lumbar degenerative spondylolisthesis
Scientific Title
Controlled study of posterior decompression and posterior fusion for the lumbar degenerative spondylolisthesis
Scientific Title:Acronym
Controlled study of posterior decompression and posterior fusion for the lumbar degenerative spondylolisthesis
Region
| Japan |
Condition
Condition
Lumbar degenerative spondylolisthesis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surgical treatment for the lumbar degenerative spondylolisthesis (DS) is commonly performed.
In general, decompression with fusion for the patient with severe slippage or instability has reached consensus. Operative procedure for the patient without severe slippage is still in discussion; decompression alone or that with fusion. Some previous studies showed no significant difference between them in clinical results or complication rates. On the other hand, some studies showed decompression with fusion have advantages in clinical results, and some showed differences in complication rates. The purpose of this study is to clarify the existence of superiority in two procedures for the DS patients without severe slippage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the efficacy of treatment using clinical scores below preoperatively, postoperative 3months, 6months, 1year, and 2years; Rolland-Morris Disability Questionnaire(RDQ), Oswestry Disability Index (ODI) 2.0, Visual Analogue Scale (VAS)of low back pain and leg pain
Key secondary outcomes
Reoperation rate, complication rate of surgery (infection, hematoma, dural tear, restenosis, progression of slippage, adjacent segmental disease, nonunion), medical complication (heart failure, pneumonia, renal failure, etc)
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Posterior lumbar decompression
Interventions/Control_2
Posterior lumbar interbody fusion/ Transforaminal lumbar interbody fusion
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
Patients with single level spondylolisthesis (slippage at least 3mm in flexion position, and %slip less than 25%), who have leg neurological symptoms (pain, numbness, and so on) resistant to conservative therapy
Key exclusion criteria
Patients who cannot get MRI, patients with previous lumbar surgery, patients with foraminal stenosis at the slippage level and neurological symptoms of same level, patients with degenerative lumbar scoliosis (Cobb angle >20 degrees), patients whose QOL assessment is significantly difficult because of comorbid illness such as Parkinson's disease, Renal failure requiring dialysis, dementia, etc
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Watanabe |
Organization
Hakodate central general hospital
Division name
Department of orthopedic surgery
Zip code
0408585
Address
33-2 honcho, Hakodate city, Hokkaido
TEL
0138-52-1231
penyomasa@gmail.com
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Watanabe |
Organization
Hakodate central general hospital
Division name
Department of orthopedic surgery
Zip code
0408585
Address
33-2 honcho, Hakodate city, Hokkaido
TEL
0138-52-1231
Homepage URL
penyomasa@gmail.com
Sponsor or person
Institute
Hakodate central general hospital, Department of orthopedic surgery
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
IRB of Hakodate Central General Hospital
Address
33-2 honcho, Hakodate city, Hokkaido
Tel
0138-52-1231
saito-h@hakochu-hp.gr.jp
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
函館中央病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 26 | 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
40
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 25 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025883
