Actively Recruiting

Phase Not Applicable
Age: 10Years - 21Years
All Genders
NCT05379868

Posterior Column Spinal Osteotomies in the Treatment of Adolescent Idiopathic Scoliosis

Led by Turku University Hospital · Updated on 2024-12-03

90

Participants Needed

2

Research Sites

365 weeks

Total Duration

On this page

Sponsors

T

Turku University Hospital

Lead Sponsor

H

Helsinki University Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Background: Posterior column osteotomies (PCO) are routinely used to facilitate curve correction in surgical treatment of adolescent idiopathic scoliosis (AIS). Data regarding routine use of PCO is controversial, with conflicting data for coronal and sagittal plane correction and clinical benefit. Use of PCO has not been studied in the surgical treatment of AIS in a prospective randomized clinical trial. Study Design: A randomized, multicenter clinical trial on children and adolescents undergoing posterior spinal fusion for idiopathic scoliosis using pedicle screw instrumentation. Sixty consecutive adolescents will be randomized into PCO or no PCO group after surgical exposure of the spine in 1:1 ratio. Aims and Hypothesis: To compare PCO vs. no PCO groups for the correction of coronal and sagittal plane curve in children undergoing posterior spinal fusion for AIS. The investigators hypothesize that the correction of coronal curve and hypokyphosis will be better in PCO group without increasing blood loss or complications. Inclusion criteria: Adolescents (aged 10 to 21 years of age) undergoing corrective surgery for idiopathic scoliosis using pedicle screw technique. Exclusion criteria: Coagulation disorder, smoking, unwilling to consent, vertebral column resection, need for anteroposterior surgery. Main outcome parameters: Primary outcome is the radiographic correction (Coronal and sagittal plane). Secondary outcomes include health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain, rib hump, operative time, blood loss, hospital stay, and complications. Ethical aspects: Ethical committee approval will be obtained. An informed consent will be obtained from all children and their parents. Time schedule and budget: This study has ethical committee approval.There will be no extra costs as all information gathered will be part of normal surgical treatment of AIS. A part-time research nurse has been hired to take care of data collection into the database.

CONDITIONS

Official Title

Posterior Column Spinal Osteotomies in the Treatment of Adolescent Idiopathic Scoliosis

Who Can Participate

Age: 10Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adolescent idiopathic scoliosis (Lenke 1 to 4)
  • Age at surgery between 10 and 21 years
  • Cobb angle of 45 degrees or more
  • Posterior spinal fusion
Not Eligible

You will not qualify if you...

  • Anteroposterior surgery
  • Vertebral column resection
  • Smoking
  • Diabetes mellitus
  • Bleeding disorder

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Helsinki University Hospital

Helsinki, Finland, FI-00029

Actively Recruiting

2

Turku University Hospital

Turku, Finland, 20900

Actively Recruiting

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Research Team

M

Matti Ahonen, MD, PhD

CONTACT

I

Ilkka Helenius, Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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