UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028676 |
|---|---|
| Receipt number | R000032828 |
| Scientific Title | The surgical outcome of decompression alone versus decompression with limited fusion for lumbar degenerative scoliosis |
| Date of disclosure of the study information | 2017/08/15 |
| Last modified on | 2017/08/15 19:05:03 |
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Basic information
Public title
The surgical outcome of decompression alone versus decompression with limited fusion for lumbar degenerative scoliosis
Acronym
The surgical outcome of decompression alone versus decompression with limited fusion for lumbar degenerative scoliosis
Scientific Title
The surgical outcome of decompression alone versus decompression with limited fusion for lumbar degenerative scoliosis
Scientific Title:Acronym
The surgical outcome of decompression alone versus decompression with limited fusion for lumbar degenerative scoliosis
Region
| Japan |
Condition
Condition
lumbar degenerative scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the usefulness of radiological parameters for surgical decision-making in patients with degenerative lumbar scoliosis (DLS) by comparing the clinical and radiological results following decompression or decompression and fusion surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surgical outcomes were reviewed, including preoperative and postoperative Cobb angles, lumbar lordosis based on radiological parameters, and Japanese Orthopaedic Association (JOA) scores.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
a decompression group that underwent decompression alone
Interventions/Control_2
a fusion group that underwent decompression and short segmental 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
| 40 | years-old | <= |
Age-upper limit
| 86 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Among patients with a Cobb angle ranging from 10-25,we evaluated 57 patients who were followed for more than two years postoperatively
Key exclusion criteria
Patients without scoliosis or Cobb angle<10,Cobb angle>25 were excluded
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Masuda |
Organization
Yokohama City University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
0457872655
mashmash4952@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Masuda |
Organization
Yokohama City University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
0457872655
Homepage URL
mashmash4952@msn.com
Sponsor or person
Institute
Yokohama City University School of Medicine
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
| 2017 | Year | 08 | Month | 15 | 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
| 2005 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 01 | Month | 02 | 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
| 2017 | Year | 08 | Month | 15 | Day |
Last modified on
| 2017 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032828
