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Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis

NCT07723053 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

  • Adolescent Idiopathic Scoliosis
  • Lenke Type 1 Adolescent Idiopathic Scoliosis
  • Lenke Type 5 Adolescent Idiopathic Scoliosis

Interventions

OTHER

Drum Tower Rule Machine Learning-Guided Decision Support

A locked machine learning-based decision support model will be used before surgery to estimate the risk of postoperative distal adding-on and provide a recommendation for lowest instrumented vertebra selection. The model output will be available to surgeons in the model-guided group only.

OTHER

Conventional LIV Decision-Making

The lowest instrumented vertebra will be selected by the surgeon according to routine clinical experience and existing surgical principles, without access to the Drum Tower Rule model output.

PROCEDURE

Posterior Spinal Fusion

All participants will undergo standard posterior spinal fusion using an all-pedicle screw instrumentation system.

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-06-30
Completion
2030-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07723053 on ClinicalTrials.gov