NCT05379868 Posterior Column Spinal Osteotomies in the Treatment of Adolescent Idiopathic Scoliosis
| NCT ID | NCT05379868 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Turku University Hospital |
| Condition | Adolescent Idiopathic Scoliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2022-06-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Anteroposterior surgery * Vertebral column resection * Smoking * Diabetes mellitus * Bleeding disorder
Contact & Investigator
Ilkka Helenius, MD, PhD
STUDY DIRECTOR
Helsinki University Central Hospital
Frequently Asked Questions
Who can join the NCT05379868 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 21 Years, studying Adolescent Idiopathic Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05379868 currently recruiting?
Yes, NCT05379868 is actively recruiting participants. Contact the research team at matti.ahonen@hus.fi for enrollment information.
Where is the NCT05379868 trial being conducted?
This trial is being conducted at Helsinki, Finland, Turku, Finland.
Who is sponsoring the NCT05379868 clinical trial?
NCT05379868 is sponsored by Turku University Hospital. The principal investigator is Ilkka Helenius, MD, PhD at Helsinki University Central Hospital. The trial plans to enroll 90 participants.