UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058118 |
|---|---|
| Receipt number | R000066425 |
| Scientific Title | A study of the effects of the posterior elements preservation on the results of lumbar spine laminoplasty |
| Date of disclosure of the study information | 2025/06/07 |
| Last modified on | 2025/06/07 22:57:25 |
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Basic information
Public title
A study of the effects of the posterior elements preservation on the results of lumbar spine laminoplasty
Acronym
A study of the effects of the posterior elements preservation on the results of lumbar spine laminoplasty
Scientific Title
A study of the effects of the posterior elements preservation on the results of lumbar spine laminoplasty
Scientific Title:Acronym
A study of the effects of the posterior elements preservation on the results of lumbar spine laminoplasty
Region
| Japan |
Condition
Condition
Lumbar spinal canal stenosis
Classification by specialty
| Orthopedics | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether preservation of the posterior elements protects the spine from degeneration and improves postoperative symptoms in lumbar spine laminoplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative 2 year Kelgren and Lawrence score increment
2 year D score increment
2 year IVD height decrement
an increase in active flexion extension angles at the surgical levels
Logistic regression analyses or multiple regression analysis were performed to assess whether surgical group was significant for the 2 year KL score increment, D score increment, and DH decrement adjusting for surgical level, age, sex, each comorbidity, and smoking history.
We determined the occurrence or deterioration i.e., incidence of instabilityat the surgical level two years after surgery.
The Japanese Orthopaedic Association Back Pain Evaluation Questionnaire was used for symptom based disability assessments before surgery and one and two years after surgery in single level laminoplasty. Logistic regression analysis was performed to determine whether the kissing spine was a significant factor for the radiographic and symptom based disability outcomes.
Surgical time, intraoperative hemorrhage, and levels of change in laboratory data within the postoperative seven days were compared between groups in single level laminoplasty.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were cases which underwent laminoplasty for lumbar spinal canal stenosis without segmental instability, which is defined by less than 3 mm of translation in flexion extension radiographs.
20 to 100 years old.
Key exclusion criteria
The exclusion criteria were cases which underwent laminoplasty for degenerative scoliosis with a Cobb angle more than 20 degrees, osteolytic spinal diseases, and adjacent segmental disease secondary to spinal fusion surgeries.
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ohnishi |
Organization
Hokkaido University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
060-8638
Address
N15W7, Sapporo, Hokkaido, Japan
TEL
011-706-5936
takashi.onishi.ortho@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ohnishi |
Organization
Hokkaido University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
060-8638
Address
N15W7, Sapporo, Hokkaido, Japan
TEL
011-706-5936
Homepage URL
takashi.onishi.ortho@gmail.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
NA
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
Hokkaido University Hospital
Address
N14W5, Sapporo, Hokkaido, Japan
Tel
011-706-5936
takashi.onishi.ortho@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
12-1-1
Org. issuing International ID_1
Tonan Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Website: https://www.mdpi.com/2077-0383/14/12/4014 PDF Version: https://www.mdpi.com/2077-0383/14/12
Publication of results
Published
Result
URL related to results and publications
Website: https://www.mdpi.com/2077-0383/14/12/4014 PDF Version: https://www.mdpi.com/2077-0383/14/12
Number of participants that the trial has enrolled
85
Results
Results. The 2 year D score increment and 2 year IVD height decrement was lower in group P. The
JOABPEQ revealed higher scores in walking ability, social life function, and mental health
in group P one year after surgery. Walking ability was the only score that remained higher
two years after surgery. The visual analog scale of pain in the buttocks and lower limbs
was lower in group P only one year after surgery. Finally, the kissing spine was not a
significant factor in any outcome.
Results date posted
| 2025 | Year | 06 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eighty five consecutive patients who underwent lumbar spine
laminoplasty
Participant flow
Eighty five consecutive patients who underwent lumbar spine
laminoplasty were retrospectively reviewed. They were nonrandomly stratified into
two groups, the posterior elements resection R group and the preservation P group,
and they were followed for two years after surgery.
Adverse events
The complications and revisions were as follows there was an inferior articular process
fracture in one case, a hematoma requiring surgery in one case, herniation of the IVD in
the operated level in one case, instability in the operated level three years after surgery
and fusion surgery in one case, surgical site infection requiring debridement and irrigation
in one case, and a dura mater tear in one case in group R there was a relapse of stenosis
requiring re-laminoplasty in one case, dehiscence of the wound requiring suturing in one
case, hematoma requiring surgery in one case and not requiring surgery in one case, an
inferior articular process fracture in one case, herniation of the IVD treated conservatively
in two cases, and a dura mater tear in two cases in group P.
Outcome measures
We radiographically analyzed the
conditions of the spine and intervertebral disc IVD two years after surgery. Namely, 2 year Kelgren and Lawrence KL score increment, 2 year D
score increment, 2 year IVD height DH decrement, and an increase in active flexion
extension angles at the surgical levels. We determined the occurrence or deterioration, i.e., incidence of instability
at the surgical level two years after surgery.
The Japanese
Orthopaedic Association Back Pain Evaluation Questionnaire JOABPEQ was used for
symptom assessments. Logistic regression analysis was performed to determine whether
the kissing spine was a significant factor for the outcomes in group R.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable.
Management information
Registered date
| 2025 | Year | 06 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066425
