UMIN-ICDS Clinical Trial

Public title

A study examining recovery and outcomes after surgery for spinal and spinal cord conditions

Acronym

DS-Surg Study

Scientific Title

A single-center prospective registry study of surgical outcomes in patients with spinal and spinal cord diseases

Scientific Title:Acronym

DS-Surg Study

Region

Japan

Condition

Degenerative spinal diseases

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to prospectively collect and analyze clinical courses and imaging data from patients undergoing surgery for degenerative spinal diseases, in order to identify factors influencing surgical outcomes and to generate evidence that contributes to the safe and effective practice of spine surgery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes in patient-reported outcome measures (PROMs) from preoperative baseline to 5 years postoperatively,
with EQ-5D as the core outcome, and JOABPEQ, ODI, VAS, ZCQ, and postoperative satisfaction assessed as complementary measures.

Key secondary outcomes

The following variables will be evaluated as key secondary outcomes

Patient related and disease related factors including disease etiology such as degenerative disease trauma infection tumor and spinal deformity
Patient related factors including patient understanding of preoperative explanations
Understanding will be assessed across three domains including understanding of the disease condition and planned surgical procedure understanding of the limitations of surgery and understanding of potential complications

Understanding will be assessed across three domains including understanding of the disease condition and planned surgical procedure understanding of the limitations of surgery and understanding of potential complications


Imaging evaluations using plain radiographs computed tomography and magnetic resonance imaging including spinal alignment pelvic parameters cervical parameters spondylolisthesis bone density related measurements soft tissue muscle evaluation calcification ossification and paravertebral muscle fatty degeneration based on the Goutallier classification

Perioperative and surgery related factors including operative time blood loss dural injury location and repair method dural adhesion location and severity physical status classification blood pressure variability and administered medications

Postoperative course and complications

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

All patients who undergo surgical treatment for spinal or spinal cord diseases at our institution between 2026 and 2030 as part of standard clinical practice.

Eligible conditions include degenerative spinal diseases (such as myelopathy, intervertebral disc herniation, spinal canal stenosis, and ossification of spinal ligaments) as well as spinal deformities (including adult spinal deformity and idiopathic scoliosis). Surgical procedures include decompression surgery, fusion surgery, and deformity correction surgery, and eligibility is not restricted by the type of surgical procedure.

Key exclusion criteria

In principle, no exclusion criteria will be applied.

Target sample size

2500

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

TEL

06-6441-5451

Email

show@yb3.so-net.ne.jp

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

TEL

06-6441-5451

Homepage URL

Email

show@yb3.so-net.ne.jp

Institute

Japan Community Healthcare Organization Osaka Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Japan Community Healthcare Organization Osaka Hospital review board

Address

4-2-78 Fukushima, Fukushima-ku, Osaka

Tel

06-6441-5451

Email

horimoto-takiko@osaka.jcho.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

独立行政法人地域医療機能推進機構　大阪病院（大阪府）

Date of disclosure of the study information

2026

Year

02

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

01

Month

08

Day

Date of IRB

2026

Year

01

Month

28

Day

Anticipated trial start date

2026

Year

01

Month

28

Day

Last follow-up date

2030

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a single-center prospective observational registry. All patients who undergo surgical treatment for spinal or spinal cord diseases at our institution between 2026 and 2030 as part of standard clinical practice will be consecutively enrolled in principle. Eligible conditions include not only degenerative diseases and spinal deformities but also trauma, infection, and tumors.
Routinely collected data from medical records, operative reports, anesthesia records, and PACS will be used; no additional interventions or imaging will be performed for research purposes. PROMs (JOABPEQ, ODI, EQ-5D, VAS, ZCQ, and satisfaction) will be assessed preoperatively and postoperatively (3 months, 6 months, 1 year, and thereafter as available). Imaging evaluations using radiographs, CT, and MRI will include alignment parameters, HU values (including phantom-calibrated values when available), calcification/ossification findings, and paravertebral muscle fatty degeneration graded by the Goutallier classification. Perioperative variables will include operative time, blood loss, dural injury (location and repair method), dural adhesion (location and severity), ASA physical status, blood pressure variability, and administered medications.
Data will be managed using a pseudonymized linkage system. Missing data will not be used as exclusion criteria but will be handled analytically. Etiology (degenerative/trauma/infection/tumor/deformity, etc.) will be treated as a key stratification factor and/or covariate in analyses exploring factors associated with surgical outcomes and postoperative course.

Registered date

2026

Year

02

Month

03

Day

Last modified on

2026

Year

02

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069218