UMIN-CTR Clinical Trial

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
Email	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
Email	shizuman.612@gmail.com

Sponsor
Institute	Wakayama Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051932