Posterior Column Spinal Osteotomies in the Treatment of Adolescent Idiopathic Scoliosis. A Randomized Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Turku University Hospital
RECRUITING
Turku
Contact Information
Primary
Matti Ahonen, MD, PhD
matti.ahonen@hus.fi
+35894711
Backup
Ilkka Helenius, Prof
ilkka.helenius@hus.fi
+35894711
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 90
Treatments
Active_comparator: Posterior column osteotomy
Apical 3-5 posterior column osteotomies in addition to standard treatment
Placebo_comparator: No osteotomies
Standard treatment
Sponsors
Collaborators: Helsinki University Central Hospital, Kuopio University Hospital
Leads: Turku University Hospital

This content was sourced from clinicaltrials.gov