UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040423 |
|---|---|
| Receipt number | 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 | 2022/05/20 20:06:24 |
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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
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
takami@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
No longer 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
| 2022 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046130
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
