UMIN-CTR Clinical Trial

Public title

Impact of intraoperative measurement technique of coronal spinal alignment using a navigational spinal rod bending system for adult spinal deformity cases

Acronym

Impact of intraoperative measurement technique of coronal spinal alignment using a navigational spinal rod bending system for adult spinal deformity cases

Scientific Title

Impact of intraoperative measurement technique of coronal spinal alignment using a navigational spinal rod bending system for adult spinal deformity cases

Scientific Title:Acronym

Impact of intraoperative measurement technique of coronal spinal alignment using a navigational spinal rod bending system for adult spinal deformity cases

Region

Japan

Condition

Degenerative lumbar kyphoscoliosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the usefulness of the new technique of intraoperative coronal spinal alignment.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of postoperative coronal spinal malalignment within one month after long corrective fusion surgery

Key secondary outcomes

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

Degenerative lumbar kyphoscoliosis with a Cobb angle >20 degrees and lumbar lordosis <20 degrees who underwent corrective surgery of the thoracic to the pelvis in our institute since 2015 have been included in this study.

Key exclusion criteria

Cases who are considered inappropriate for this study.

Target sample size

60

Name of lead principal investigator

1st name	Masanari
Middle name
Last name	Takami

Organization

Wakayama Medical University

Division name

Orthopaedic surgery

Zip code

6418510

Address

811-1 Kimiidera, Wakayama

TEL

0734410645

Email

takami@wakayama-med.ac.jp

Name of contact person

1st name	Masanari
Middle name
Last name	Takami

Organization

Wakayama Medical University

Division name

Orthopaedic surgery

Zip code

6418510

Address

811-1 Kimiidera, Wakayama

TEL

0734410645

Homepage URL

Email

takami@wakayama-med.ac.jp

Institute

Wakayama Medical University, department of orthopaedic surgery

Institute

Department

Personal name

Organization

Wakayama Medical University, department of orthopaedic surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee of Wakayama Medical University

Address

811-1 Kimiidera, Wakayama

Tel

0734410645

Email

wa-rinri@wakayama-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

10

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

67

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

Completed

Date of protocol fixation

2020

Year

01

Month

17

Day

Date of IRB

2020

Year

03

Month

11

Day

Anticipated trial start date

2020

Year

03

Month

11

Day

Last follow-up date

2020

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The following demographic characteristics of patients at baseline were investigated: sex, age, body mass index (BMI), and preoperative sagittal and coronal spinal alignment. As sagittal alignment parameters, pelvic incidence (PI), lumbar lordosis (LL), pelvic tilt (PT), sacral slope (SS), PI-LL mismatch, sagittal vertical axis (SVA) were evaluated preoperatively. As coronal alignment parameters, lumbar Cobb angle, C7-CSVL (deviation of C7 plumb line off central sacral vertical line), coronal malalignment pattern (concave CSM and convex CSM) by referring to the report by Obeid et al., L5 tilt angle, S1 tilt angle, sum of coronal deformity angles obtained by adding a coronal wedge-shaped deformity angle of each vertebral body from L1 to L5 to above-mentioned S1 tilt (CDA), and coronal spinal rigidity (CSR) defined as the reduction ratio of Cobb angle between standing and traction position in the frontal view of X-ray were measured.
For an evaluation of accuracy of this method, coronal alignment of a fused range by instrumentation was investigated, that is, UIV-CSVL (deviation of upper instrumented vertebra plumb line off central sacral vertical line) obtained finally by this method during surgery was compared with an usual measurement method on the standing position X-ray postoperatively. For an evaluation of efficacy of this method, postoperative C7-CSVL on the standing position X-ray was compared between this method group and conventional method group.
Furthermore, incidence of postoperative coronal malalignment was compared in both groups. For the postoperative measurement, a whole spinal X-ray image on the standing position within four weeks after surgery was used.

Registered date

2020

Year

10

Month

17

Day

Last modified on

2020

Year

10

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048108