Posterior Column Spinal Osteotomies in the Treatment of Adolescent Idiopathic Scoliosis
ASPO
1 other identifier
interventional
90
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
2 active sites
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
March 23, 2022
CompletedFirst Posted
Study publicly available on registry
May 18, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
December 3, 2024
November 1, 2024
5 years
March 23, 2022
November 27, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Scoliosis correction
Cobb angle
2 year follow-up
Forced vital capacity
Lung volume
2 year follow-up
Kyphosis correction
Cobb angle
2 year follow-up
Secondary Outcomes (2)
Opioid consumption
48 hours
SRS-24 total score
2 year follow-up
Study Arms (2)
Posterior column osteotomy
ACTIVE COMPARATORApical 3-5 posterior column osteotomies in addition to standard treatment
No osteotomies
PLACEBO COMPARATORStandard treatment
Interventions
Apical full facet joint resection. Study intervention does not involve a device.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Anteroposterior surgery
- Vertebral column resection
- Smoking
- Diabetes mellitus
- Bleeding disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Turku University Hospitallead
- Helsinki University Central Hospitalcollaborator
- Kuopio University Hospitalcollaborator
Study Sites (2)
Helsinki University Hospital
Helsinki, FI-00029, Finland
Turku University Hospital
Turku, 20900, Finland
Related Publications (1)
Hresko MT. Clinical practice. Idiopathic scoliosis in adolescents. N Engl J Med. 2013 Feb 28;368(9):834-41. doi: 10.1056/NEJMcp1209063. No abstract available.
PMID: 23445094BACKGROUND
Study Officials
- STUDY DIRECTOR
Ilkka Helenius, MD, PhD
Helsinki University Central Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will not be informed of chosen treatment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 23, 2022
First Posted
May 18, 2022
Study Start
June 1, 2022
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2029
Last Updated
December 3, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Original data will be available only upon a reasonable request from the Principal Investigator at the time of publication