Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis (NCT07723053) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis
China300 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
10 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Distal Adding-on
Timeframe: 24 months after surgery
Trial details
NCT IDNCT07723053
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School