UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060881 |
|---|---|
| Receipt number | R000069651 |
| Scientific Title | Preoperative MRI/CT Prediction of Dural Adhesion to Surrounding Tissues in Primary Spinal Surgery: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/03/21 |
| Last modified on | 2026/03/10 06:57:55 |
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Basic information
Public title
Predicting Dural Adhesion Before First-Time Spinal Surgery Using Preoperative Imaging
Acronym
ADHERE Study
Scientific Title
Preoperative MRI/CT Prediction of Dural Adhesion to Surrounding Tissues in Primary Spinal Surgery: A Prospective Observational Study
Scientific Title:Acronym
ADHERE Study
Region
| Japan |
Condition
Condition
Spinal surgery involving direct decompression with exposure of the dura mater
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between preoperative MRI (including axial T1-weighted images) and CT findings and the intraoperative dural-ligamentum flavum adhesion, and to optimize surgical strategies such as surgical approach, dissection technique, surgeon allocation, and preoperative risk explanation.
Basic objectives2
Others
Basic objectives -Others
Imaging evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between intraoperative dural-ligamentum flavum adhesion grade (0-3) and preoperative imaging parameters.
Definition of adhesion grades
Grade 0 (none): Easily separable with blunt dissection, with minimal resistance. A clear dissection plane between the dura mater and the ligamentum flavum can be readily created.
Grade 1 (mild): Some resistance or adherence is present, but separation is possible mainly with blunt dissection (sharp dissection is generally not required).
Grade 2 (moderate): Repeated blunt dissection is required. Partial sharp dissection or leaving a thin layer at the adhesion site may occasionally be necessary.
Grade 3 (severe): A dissection plane is difficult to obtain with blunt dissection, indicating near fusion of the tissues. Sharp dissection or a change in surgical strategy (e.g., leaving the adhesion in place) is required.
Key secondary outcomes
Interobserver agreement of adhesion grading (primary surgeon vs assistant surgeon): weighted kappa coefficient.
Performance of models predicting severe adhesion (e.g., Grade 3 or Grade 2 and above), evaluated by the area under the receiver operating characteristic curve (AUC).
Association between adhesion grade and intraoperative outcomes such as incidental dural tear, need for sharp dissection, operative time, and estimated blood loss.
Differences in imaging parameters and clinical outcomes between adhesion cases and matched controls in matched analysis.
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
Patients who meet all of the following criteria:
1. Patients undergoing spinal surgery (cervical, thoracic, or lumbar) at our institution, including endoscopic decompression, open decompression, and direct decompression performed with fusion procedures.
2. At least one intervertebral level in which the dura mater is exposed intraoperatively and the ligamentum flavum (or surrounding tissues) is dissected from the dura.
3. The target intervertebral level must not be a revision site (no previous surgery at the same level). Cases may be included even if other levels in the same operation are revision sites, provided that the target level is a primary surgery site.
4. Preoperative MRI (including axial T1-weighted images) and CT obtained as part of routine clinical care at our institution.
Key exclusion criteria
Patients (or intervertebral levels) meeting any of the following criteria will be excluded:
1. Revision surgery at the same intervertebral level.
2. Fusion procedures intended only for indirect decompression (e.g., cases or levels in which direct decompression exposing the dura mater is not performed).
3. Conditions in which the mechanism of adhesion formation differs substantially from that of typical degenerative disease, such as infection, tumor, trauma, or inflammatory disorders.
4. Preoperative imaging not suitable for evaluation.
5. Refusal of participation in the study by the patient (or legally authorized representative).
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Takenaka |
Organization
Japan Community Healthcare Organization Osaka Hospital
Division name
Department of orthopaedic surgery
Zip code
553-0003
Address
4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan
TEL
06-6441-5451
show@yb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Takenaka |
Organization
Japan Community Healthcare Organization Osaka Hospital
Division name
Department of orthopaedic surgery
Zip code
553-0003
Address
4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan
TEL
06-6441-5451
Homepage URL
show@yb3.so-net.ne.jp
Sponsor or person
Institute
Japan Community Healthcare Organization Osaka Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Japan Community Healthcare Organization Osaka Hospital review board
Address
4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan
Tel
06-6441-5451
horimoto-takiko@osaka.jcho.go.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
| 2026 | Year | 03 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2031 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Single-center prospective cohort study.
Recruitment: Consecutive eligible patients undergoing spinal surgery at our institution.
Registration unit: patient. Analysis unit: eligible intervertebral level.
Sampling: consecutive sampling.
Main predictors: prespecified preoperative MRI/CT parameters.
Main outcome: intraoperative dural-ligamentum flavum adhesion grade (Grades 0-3).
Data to be Collected
The following data will be collected from medical records, imaging studies, and operative reports.
1. Patient characteristics: age, sex, BMI, comorbidities (e.g., diabetes), smoking history, and use of anticoagulant or antiplatelet medications.
2. Diagnosis: cervical spondylotic myelopathy or radiculopathy, OPLL or OLF, spinal canal stenosis, intervertebral disc herniation, degenerative spondylolisthesis, etc.
3. Surgical information: surgical procedure (e.g., endoscopic decompression, open decompression, laminoplasty, or direct decompression performed with fusion procedures), target level, extent of decompression (unilateral or bilateral), operative time, and estimated blood loss.
4. Intraoperative assessment: adhesion grade (assessed by the primary surgeon, assistant surgeon, and final consensus), need for sharp dissection, strategies such as leaving a thin layer at the adhesion site, and presence of incidental dural tear and its repair method.
5. Postoperative course (optional): CSF leak related events, reoperation, and length of hospital stay.
Management information
Registered date
| 2026 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069651
