Posterior Column Spinal Osteotomies in the Treatment of Adolescent Idiopathic Scoliosis

Summary

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

• Adolescent Idiopathic Scoliosis

Interventions

PROCEDURE

Posterior column osteotomy

Apical full facet joint resection. Study intervention does not involve a device.

PROCEDURE

No osteotomies

Standard treatment

Sponsors & Collaborators

• Helsinki University Central Hospital

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Turku University Hospital

  lead OTHER_GOV

Principal Investigators

• Ilkka Helenius, MD, PhD · Helsinki University Central Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2027-06-01

Completion

2029-06-01

FDA Device

Yes

Countries

• Finland

Study Locations