Clinical Trial

Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis

Not Yet Recruiting
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Summary
This study will evaluate whether a machine learning-based decision support model, called the Drum Tower Rule, can help surgeons select the lowest instrumented vertebra during corrective surgery for adolescent idiopathic scoliosis. Patients with Lenke type 1 or Lenke type 5 adolescent idiopathic scoliosis who are scheduled for posterior spinal fusion will be randomly assigned to one of two groups. In the model-guided group, surgeons will receive the model-predicted risk of postoperative distal adding-on and a recommendation for lowest instrumented vertebra selection. In the conventional-experience group, surgeons will select the lowest instrumented vertebra according to routine clinical experience and existing surgical principles, without access to the model output. All patients will receive standard posterior spinal fusion. The main outcome is the incidence of distal adding-on at 24 months after surgery, assessed by blinded radiographic reviewers.
Trial Details
NCT Number NCT07723053
Lead Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions Adolescent Idiopathic Scoliosis, Lenke Type 1 Adolescent Idiopathic Scoliosis, Lenke Type 5 Adolescent Idiopathic Scoliosis
Enrollment 300 participants
Start Date 2026-07-01
Primary Completion 2027-06 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-23