Posterior Column Spinal Osteotomies in the Treatment of Adolescent Idiopathic Scoliosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-21
SponsorTurku University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Anteroposterior surgery

Vertebral column resection

Smoking

Diabetes mellitus

Trial design

Design model

Parallel

Treatments tested in this trial

  • Posterior column osteotomy

    Procedure/Surgery

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

  • No osteotomies

    Procedure/Surgery

    Standard treatment

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Posterior column osteotomyActive comparator 1 intervention
Group B: No osteotomiesPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Scoliosis correction

Cobb angle

Time frame
2 year follow-up
2

Forced vital capacity

Lung volume

Time frame
2 year follow-up
3

Kyphosis correction

Cobb angle

Time frame
2 year follow-up

Secondary outcomes

1

Opioid consumption

Pain outcome

Time frame
48 hours
2

SRS-24 total score

Health-Related Quality of Life

Time frame
2 year follow-up

Other outcomes

Sponsors and contacts

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Turku University Hospital

Lead sponsor

Helsinki University Central Hospital

Collaborator

Kuopio University Hospital

Collaborator