UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045489 |
|---|---|
| Receipt number | R000051932 |
| Scientific Title | Observational study of early sacroiliac joint disorders after adult spinal deformity |
| Date of disclosure of the study information | 2021/09/15 |
| Last modified on | 2021/09/15 16:46:11 |
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Basic information
Public title
Observational study of early sacroiliac joint disorders after adult spinal deformity
Acronym
Observational study of early sacroiliac joint disorders after adult spinal deformity
Scientific Title
Observational study of early sacroiliac joint disorders after adult spinal deformity
Scientific Title:Acronym
Observational study of early sacroiliac joint disorders after adult spinal deformity
Region
| Japan |
Condition
Condition
adult spinal deformity
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sacroiliac joint pain (SIJP) is one of the pathological conditions of adjacent segment disorders after adult spinal deformity (ASD) surgery. This study aims to test the hypothesis that even in ASD surgery using S2 alar-iliac (S2AI) screws, SIJP can develop much earlier than previously reported and can be rescued by ultrasound-guided sacroiliac joint block.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All patients with ASD, treated with long spinal fusion using S2AI screws, are prospectively investigated for SIJP postoperatively, and the effect of ultrasound-guided sacroiliac joint block evaluated. Additionally, the relationship between the symptomatic side of the SIJP and the surgical procedure; the preoperative and postoperative whole spine sagittal and coronal alignment, lumbar pelvis sagittal plane alignment and pelvic incidence-lumbar lordosis are retrospectively compared between the groups with and without SIJP.
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
Between January 2019 and December 2020, all consecutive patients who have (1) symptomatic ASD and (2) receive long corrective fusion from the thorax to the pelvis using S2AI screws are enrolled in the study.
Key exclusion criteria
The exclusion criteria are as follows: (1) history of spine surgery, (2) bedridden status due to pre-existing problems, (3) current severe infection, or concurrent acute fracture.
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Iwasaki |
Organization
Wakayama Medical University
Division name
Department of Orthopedic Surgery
Zip code
6418510
Address
811-1 Kimiidera, Wakayama
TEL
0734410645
hiroshiiwasaki2334@gmail.com
Public contact
Name of contact person
| 1st name | Shizumasa |
| Middle name | |
| Last name | Murata |
Organization
Wakayama Medical University
Division name
Department of Orthopedic Surgery
Zip code
6418510
Address
811-1 Kimiidera, Wakayama
TEL
0734410645
Homepage URL
shizuman.612@gmail.com
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopedic Surgery, Wakayama Medical University
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
Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Japan
Tel
0734410645
shizuman.612@gmail.com
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
| 2021 | Year | 09 | Month | 15 | 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
98
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 | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate the sex, age, body mass index (BMI), bone mineral density (BMD), type of deformity (kyphosis or kyphoscoliosis), and upper instrumented vertebra (UIV) of the target patients. For cases with SIJP, the onset date of SIJP, symptomatic side of SIJP, night pain, positive rate of each test of "A Diagnostic Scoring System for SIJP" and the number of times the SIJ block was administered, are investigated. In addition, the relationship between the symptomatic side of the SIJP and the approach side of the lumbar interbody fusion (LIF), donor site of the iliac bone graft, and dislocation of the S2AI screw are also retrospectively investigated. To clarify the appearance tendency of SIJP, C7 SVA as an indicator of the whole spine sagittal alignment, the C7 plumb line-center sacral vertical line (C7PL-CSVL) as an indicator of the whole spine coronal alignment, and pelvic tilt (PT) and PI-LL as indicators of lumbar pelvis sagittal plane alignment are evaluated preoperatively and postoperatively, and results and changes are compared between the SIJP positive and negative groups. All parameters are evaluated before surgery and one month after surgery.
Management information
Registered date
| 2021 | Year | 09 | Month | 15 | Day |
Last modified on
| 2021 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051932
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