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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040423
Receipt No. R000046130
Scientific Title Formation of lateral bridging callus outside cages following extreme lateral interbody fusion: a retrospective observational study
Date of disclosure of the study information 2020/05/17
Last modified on 2020/05/17

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Basic information
Public title Formation of lateral bridging callus outside cages following extreme lateral interbody fusion: a retrospective observational study
Acronym Formation of lateral bridging callus outside cages following extreme lateral interbody fusion: a retrospective observational study
Scientific Title Formation of lateral bridging callus outside cages following extreme lateral interbody fusion: a retrospective observational study
Scientific Title:Acronym Formation of lateral bridging callus outside cages following extreme lateral interbody fusion: a retrospective observational study
Region
Japan

Condition
Condition Degenerative lumbar disease
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Lateral bridging callus outside cages (LBC) were often observed following extreme lateral interbody fusion (XLIF), despite no bone graft outside cages. An objective of this study is to investigate an incidence, factors, and features of formation of LBC at the interbody treated by XLIF retrospectively.
Basic objectives2 Others
Basic objectives -Others Additionally, another objective of this study is to detect requirements to reduce or omit autogenous bone grafting.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes An incidence, factors(sex, age, body mass index, bone density (T-score), with or without injection of teriparatide before over two months preoperatively, intervertebral levels, heights of cages, materials of cages (titanium or poly ether ether ketone (PEEK)), Cobb angles and lengths of the osteophytes in every intervertebral level on the front view on the X-rays, presence or absence of diffuse idiopathic skeletal hyperostosis, pelvic incidence, a method of posterior fixation), and features of formation of LBC at the interbody treated by XLIF
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Cases by examined by computed tomography after Lumbar fusion surgery by XLIF
Key exclusion criteria Not applicable
Target sample size 95

Research contact person
Name of lead principal investigator
1st name Masanari
Middle name
Last name Takami
Organization Wakayama Medical University
Division name Orthopaedic surgery
Zip code 6418510
Address 811-1 Kimiidera, Wakayama
TEL 0734410645
Email maatomo324@gmail.com

Public contact
Name of contact person
1st name Masanari
Middle name
Last name Takami
Organization Wakayama Medical University
Division name Orthopaedic surgery
Zip code 6418510
Address 811-1 Kimiidera, Wakayama
TEL 0734410645
Homepage URL
Email takami@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
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 Research Ethics Committee of Wakayama Medical University
Address 811-1 Kimiidera, Wakayama
Tel 0734410645
Email takami@wakayama-med.ac.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

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 17 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 Open public recruiting
Date of protocol fixation
2019 Year 12 Month 20 Day
Date of IRB
2019 Year 12 Month 20 Day
Anticipated trial start date
2019 Year 12 Month 20 Day
Last follow-up date
2024 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, 259 interbody levels in consecutive 95 patients that underwent lumbar fusion surgery including XLIF in our institute from February 2013 and evaluated by computed tomography (CT) at one-year postoperatively were enrolled. First, we will reveal an incidence of LBC. Factors that can lead to occur the LBC were evaluated.

Management information
Registered date
2020 Year 05 Month 17 Day
Last modified on
2020 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046130

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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