UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056487 |
|---|---|
| Receipt number | R000064548 |
| Scientific Title | A prospective cohort study on the impact of pentosidine on instrumentation failure after lumbar interbody fusion surgery |
| Date of disclosure of the study information | 2024/12/18 |
| Last modified on | 2025/04/30 21:49:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The impact of pentosidine on instrumentation failure after lumbar interbody fusion surgery
Acronym
he impact of pentosidine on instrumentation failure
Scientific Title
A prospective cohort study on the impact of pentosidine on instrumentation failure after lumbar interbody fusion surgery
Scientific Title:Acronym
A prospective cohort study on the impact of pentosidine on instrumentation failure
Region
| Japan |
Condition
Condition
Lumbar degenerative diseases
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether serum pentosidine levels and urinary pentosidine levels affect bone fusion in lumbar interbody fusion surgery.
Basic objectives2
Others
Basic objectives -Others
The complication rate
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurrence of pedicle screw loosening, cage subsidence, and cage retropulsion up to 24 months postoperatively.
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
| 55 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients undergoing posterior lumbar interbody fusion (PLIF/TLIF) for degenerative conditions such as lumbar degenerative spondylolisthesis, lumbar isthmic spondylolisthesis, lumbar spondylolysis, or lumbar foraminal stenosis.
2.Patients aged 55 years or older at the time of surgery.
3.Patients who have received sufficient explanation about this study, fully understood the details, and provided voluntary consent either personally or through a representative.
Key exclusion criteria
1.Patients undergoing surgery for pyogenic spondylitis or tuberculous spondylitis.
2.Patients undergoing surgery for metastatic bone tumors.
3.Patients undergoing surgery for spinal trauma or spinal cord injury.
4.Patients undergoing hemodialysis.
5.Patients with a history of lumbar fusion surgery.
6.Patients deemed unsuitable for inclusion in the study by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yukitoshi |
| Middle name | |
| Last name | Shimmaura |
Organization
Hakodate Central General Hospital
Division name
Spine Center
Zip code
0408585
Address
Honcho 33-2, Hakodate, Hokkaido, Japan
TEL
0138-52-1231
shimamuy82055@gmail.com
Public contact
Name of contact person
| 1st name | Yukitoshi |
| Middle name | |
| Last name | Shimamura |
Organization
Hakodate Central General Hospital
Division name
Spine Center
Zip code
0408585
Address
Honcho 33-2, Hakodate, Hokkaido, Japan
TEL
0138-52-1231
Homepage URL
shimamuy82055@gmail.com
Sponsor or person
Institute
Yukitoshi Shimamura, Spine Center, Hakodate Central General Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakodate Central General Hospital Ethics Committee
Address
Honcho 33-2, Hakodate, Hokkaido, Japan
Tel
0138-52-1231
kubota-y@hakochu-hp.gr.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
| 2024 | Year | 12 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe whether serum and urinary pentosidine are associated with instrumentation failure after lumbar fusion surgery.
Management information
Registered date
| 2024 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064548
