NCT04822935

Brief Summary

Scoliosis is a 3-dimensional, structural deformity of the spine. Idiopathic scoliosis is the most common type and it constitutes 75-80% of all scoliosis. Surgical methods are the most effective way to correct the deformity in patients who cannot achieve adequate improvement with supportive therapy. Adolescent idiopathic scoliosis surgeries are among the most invasive surgeries performed on children and adolescents. Large surgical incision and massive tissue damage cause severe postoperative pain. In this study, we aim to compare posterior instrumentation (PE) and vertebral body tethering (VBT) surgeries performed in adolescent idiopathic scoliosis patients in terms of anesthetic management and postoperative pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2021

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

January 30, 2021

Last Update Submit

November 18, 2021

Conditions

Scoliosis; Adolescence

Outcome Measures

Primary Outcomes (1)

  • Comparison in terms of postoperative pain

    Opioid consumption and VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable) for measurement of postoperative pain

    48 hours

Study Arms (2)

Posterior Spinal Instrumentation

NO INTERVENTION

Vertebral Body Tethering

EXPERIMENTAL
Procedure: Vertebral Body Tethering

Interventions

Vertebral Body TetheringPROCEDURE

VBT surgery is a surgery performed by thoracotomy in adolescent idiopathic scoliosis patients.

Vertebral Body Tethering

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ASA score 1-3 patients
  • Adolescent idiopathic scoliosis patients
  • Patients who accepted to be included in the study and received written parental consent

You may not qualify if:

  • Patients with vertebral anomaly due to a secondary reason
  • Patients with a diagnosed syndrome
  • Patients with a Cobb angle below 40.
  • Patients who undergoing reoperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Istanbul Medical Faculty

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Canbolat N, Basaran I, Altun D, Akgul T, Buget MI. Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery: A Randomized Controlled Trial. Pain Physician. 2022 Jul;25(4):E589-E596.

    PMID: 35793183DERIVED

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Irem Basaran, MD

    Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, M.D.

Study Record Dates

First Submitted

January 30, 2021

First Posted

March 30, 2021

Study Start

June 30, 2021

Primary Completion

November 7, 2021

Study Completion

November 17, 2021

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations

TU(1)