Actively Recruiting
Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis INDIRECT Trial
Led by Peking Union Medical College Hospital · Updated on 2024-10-21
132
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the clinical effectiveness of intervertebral disc release (IDR) in treating adolescents aged 10 to 18 with Lenke 5 type adolescent idiopathic scoliosis (AIS). The study compares IDR with Ponte osteotomy to assess improvements in vertebral rotation correction, coronal curve angles, blood loss, hospital stay length, and adverse events. The trial focuses on providing robust clinical evidence to enhance treatment strategies for this specific scoliosis type and potentially for AIS overall. Participants will be randomly assigned to one of two groups: the IDR group, which receives intervertebral disc release following Ponte osteotomy at certain vertebral levels, or the PO group, which receives only Ponte osteotomy. Both procedures involve posterior instrumentation, fusion, and corrective maneuvers such as rod rotation and segmental derotation. The IDR technique includes incising and removing disc material to allow better derotation and reduce fusion levels. During the study, participants will undergo various evaluations including measurements of axial vertebral rotation correction, lumbar curve, vertebral tilt, and other radiographic parameters at multiple time points before surgery and up to three years post-surgery. Clinical assessments will include blood loss, transfusion rates, hospital stay length, infection rates, nerve damage, and patient-reported outcome measures such as SRS-22, SF-36, and EQ-5D questionnaires. Data quality will be ensured through regular audits, and the total participation duration includes up to three years of follow-up.
CONDITIONS
Brief Title
Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 10 and 18 years
- American Society of Anesthesiologists (ASA) physical status classification of I-II
- Diagnosed with Lenke 5 type adolescent idiopathic scoliosis
You will not qualify if you...
- History of previous corrective surgery for scoliosis
- Sharp, angulated short-segmental scoliosis
- Congenital scoliosis requiring 3-column osteotomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay after surgery (exact duration varies per participant)
Participants undergo posterior correction surgery with internal fixation and bone graft fusion. Depending on the group, surgery includes either Ponte osteotomy alone or Ponte osteotomy followed by intervertebral disc release. This stage includes the surgical procedure and immediate recovery in the hospital.
1 surgical hospitalization period
Duration - Up to 3 years
Participants are monitored through follow-up visits to assess correction rates, radiographic parameters, functional scores, and adverse events over several years after surgery.
Visits at 1 week, 3 months, 6 months, 1 year, 2 years, and 3 years post surgery
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100035
Actively Recruiting
Research Team
Q
Qianyu Zhuang, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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