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NOT YET RECRUITING
NCT07723053
NA

Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

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.

Official title: A Prospective Randomized Controlled Trial of the Drum Tower Rule Machine Learning Model for Lowest Instrumented Vertebra Selection in Lenke Type 1 and Type 5 Adolescent Idiopathic Scoliosis

Key Details

Gender

All

Age Range

10 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-07-01

Completion Date

2030-09

Last Updated

2026-07-23

Healthy Volunteers

No

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.

Locations (1)

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

Nanjing, Jiangsu, China