UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The surgical outcome of decompression alone versus decompression with limited fusion for lumbar degenerative scoliosis
Title of the study (Brief title)	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	Kenji Masuda
Organization	Yokohama City University School of Medicine
Division name	Department of Orthopaedic Surgery
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	0457872655
Email	mashmash4952@msn.com

Public contact
Name of contact person	Kenji Masuda
Organization	Yokohama City University School of Medicine
Division name	Department of Orthopaedic Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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