Actively Recruiting
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
Eligibility Criteria
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
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
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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