Effectiveness of Intervertebral Disc Release for Adolescent Idiopathic Scoliosis
Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis (INDIRECT)
This study is testing whether a new surgery called intervertebral disc release can help teenagers with a specific type of scoliosis get better results than a standard surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06279468 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intervertebral disc release (IDR) in treating Lenke 5 adolescent idiopathic scoliosis (AIS) compared to Ponte osteotomy. It aims to assess improvements in axial vertebral rotation and coronal curve correction, as well as to monitor blood loss, hospital stay duration, and adverse events. Participants aged 10-18 with Lenke 5 AIS will be randomly assigned to receive either IDR or Ponte osteotomy. The study will measure various clinical and radiographic outcomes to determine the superiority of IDR in achieving better correction rates.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10-18 diagnosed with Lenke 5 type adolescent idiopathic scoliosis.
Not a fit: Patients with a history of previous corrective surgery or those with congenital scoliosis requiring extensive osteotomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications for adolescents with Lenke 5 AIS.
How similar studies have performed: While there have been studies on osteotomy techniques, the specific approach of intervertebral disc release in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Qianyu Zhuang, Professor — Peking Union Medical College Hospital
- Study coordinator: Qianyu Zhuang, Professor
- Email: baizhuosong@126.com
- Phone: +86 15200838996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.