NCT06279468 Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis
| NCT ID | NCT06279468 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Adolescent Idiopathic Scoliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-09-01 |
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 132 participants in total. It began in 2024-09-01 with a primary completion date of 2026-09-01.
⚠ 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
Adolescent idiopathic scoliosis (AIS) poses challenges in achieving optimal three-dimensional correction. While posterior fusion with pedicle screws has shown success, osteotomy techniques, such as Ponte osteotomy, have further improved outcomes. However, residual vertebral rotation remains a concern, impacting long-term complications. Intervertebral disc release (IDR) presents a potential solution to enhance derotation and reduce fusion levels, particularly in Lenke Type 5 AIS. This prospective randomized controlled trial aims to evaluate the clinical effectiveness of IDR in treating Lenke 5 AIS, comparing it to Ponte osteotomy. The study focuses on axial vertebral rotation correction, coronal curve improvement, blood loss, hospital stay, and adverse events. Participants aged 10-18 with Lenke 5 AIS will undergo either IDR or Ponte osteotomy, randomly assigned. Outcome measures include axial rotation correction rate, radiographic parameters, and clinical assessments. A total of 132 participants will be recruited. The IDR technique, through posterior disc removal, presents a promising approach to optimize derotation in Lenke 5 AIS. While offering potential advantages, challenges like limited working space and bleeding risks require careful consideration. The study's findings aim to provide robust clinical evidence, enhancing treatment strategies for Lenke 5 AIS and offering innovative approaches for AIS as a whole.
Eligibility Criteria
Inclusion Criteria: * Between the ages of 10 and 18 * American Society of Anesthesiologists (ASA) physical statusclassification of I-II * Lenke 5 type adolescent idiopathic scoliosis Exclusion Criteria: * A history of previous corrective surgery * With sharp, angulated short-segmental scoliosis * With congenital scoliosis requiring 3-column osteotomy
Contact & Investigator
Qianyu Zhuang, Professor
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT06279468 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 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 NCT06279468 currently recruiting?
Yes, NCT06279468 is actively recruiting participants. Contact the research team at baizhuosong@126.com for enrollment information.
Where is the NCT06279468 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06279468 clinical trial?
NCT06279468 is sponsored by Peking Union Medical College Hospital. The principal investigator is Qianyu Zhuang, Professor at Peking Union Medical College Hospital. The trial plans to enroll 132 participants.