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AI takes the guesswork out of scoliosis surgery

NCT ID NCT07723053

Disease control Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether a machine learning tool, called the Drum Tower Rule, can help surgeons select the lowest vertebra to fuse during corrective surgery for adolescent idiopathic scoliosis. About 300 teens with specific curve types will be randomly assigned to have surgery guided by the model or by standard surgeon experience. The goal is to see if the model reduces the chance of the spine curving again below the fused area within two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a machine learning decision-support model called the Drum Tower Rule
What this could lead to
If successful, this approach could reduce the risk of spinal curve progression after scoliosis surgery, improving long-term outcomes for adolescents.
What could go wrong
The model is untested in real-time surgery, and its recommendations may not always outperform a surgeon's judgment. The trial is also limited to specific curve types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of adolescent idiopathic scoliosis classified as Lenke type 1A or Lenke type 5C. * Age 10 to 18 years, inclusive. * Scheduled to undergo posterior spinal fusion using an all-pedicle screw instrumentation system. * Planned selective thoracic fusion or selective lumbar fusion, with a clinical need for lowest instrumented vertebra decision-making. * Availability of required preoperative standing full-spine radiographs and bending radiographs. * Ability and willingness to complete the planned 24-month postoperative follow-up. * Written informed consent provided by the participant and legal guardian. Exclusion Criteria: * \- Congenital scoliosis, neuromuscular scoliosis, syndromic scoliosis, or other non-idiopathic scoliosis. * History of spinal trauma, spinal tumor, spinal tuberculosis, or spinal infection. * Previous spinal surgery. * Severe sagittal spinal deformity, such as Scheuermann disease, for which the study model is not applicable. * Neurological symptoms or signs. * Leg length discrepancy greater than 10 mm. * The surgeon determines that there is no clinical equipoise for lowest instrumented vertebra selection because one option is clearly contraindicated for safety or anatomical reasons. * Inability to complete follow-up or required study assessments.

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Conditions

The condition(s) this trial relates to.

adolescent idiopathic scoliosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adolescent idiopathic scoliosis Lenke type 1 adolescent idiopathic scoliosis Lenke type 5 adolescent idiopathic scoliosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Nanjing, Jiangsu, 210008, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.