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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028676
Receipt No. 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

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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
Email 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
Email mashmash4952@msn.com

Sponsor
Institute Yokohama City University School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032828

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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