Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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

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.

Eligibility

Primary outcome measure(s)

• Incidence of Distal Adding-on — 24 months after surgery
  Distal adding-on is defined as an increase of more than 5 degrees in the disc angle below the lowest instrumented vertebra compared with the immediate postoperative radiograph, or an increase of more than 5 mm in the translation of the vertebra below the lowest instrumented vertebra relative to the central sacral vertical line. The outcome will be assessed by blinded radiographic reviewers.

Trial sites (1)

More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China

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