Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis

19. juli 2026 oppdatert av: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Adolescent idiopathic scoliosis is a common spinal deformity in children and adolescents. For patients requiring corrective surgery, selection of the lowest instrumented vertebra is a key surgical decision. An inappropriate distal fusion level may increase the risk of postoperative distal adding-on, coronal imbalance, unnecessary loss of spinal mobility, or revision surgery.

The Drum Tower Rule is a machine learning-based decision support model developed to estimate the risk of postoperative distal adding-on and assist with lowest instrumented vertebra selection in patients with Lenke type 1 and Lenke type 5 adolescent idiopathic scoliosis. Before the start of this trial, the model, input variables, risk threshold, and software version will be locked and will not be modified during the study.

This is a single-center, prospective, randomized, open-label, parallel-group controlled trial with blinded outcome assessment. Eligible participants will be randomly assigned in a 1:1 ratio to either the model-guided group or the conventional-experience group. Randomization will be stratified by Lenke classification.

In the model-guided group, preoperative clinical and radiographic variables will be entered into the locked machine learning model. The model will generate a predicted risk of distal adding-on and a recommendation for lowest instrumented vertebra selection. For Lenke type 1 patients, the decision will focus on selection between one level proximal to the last substantially touching vertebra and the last substantially touching vertebra. For Lenke type 5 patients, the decision will focus on selection between L3 and L4. The surgeon will make the final decision after considering the model output and clinical judgment.

In the conventional-experience group, the surgeon will select the lowest instrumented vertebra based on routine clinical experience and existing surgical principles. The model output will not be provided to the surgeon for participants in this group.

Both groups will undergo standard posterior spinal fusion with an all-pedicle screw instrumentation system. Postoperative follow-up will be performed at 1 week and at 3, 6, 12, and 24 months after surgery. The primary outcome is the incidence of distal adding-on at 24 months after surgery. Secondary outcomes include number of fused segments, Cobb angle correction rate, coronal balance, sagittal radiographic parameters, Scoliosis Research Society-22 score, visual analog scale score for low back pain, complications, instrumentation failure, revision surgery, and adoption of model recommendations.

The primary outcome will be assessed by independent radiographic reviewers who are blinded to treatment allocation.

Studietype

Intervensjonell

Registrering (Antatt)

300

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Xiaodong Qin, MD, PhD
  • Telefonnummer: 025-68182923
  • E-post: gyethics@163.com

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210008
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Model-Guided Group
Participants in this group will undergo standard posterior spinal fusion. Before surgery, preoperative clinical and radiographic variables will be entered into the locked Drum Tower Rule machine learning model. The model will generate a predicted risk of distal adding-on and a recommendation for lowest instrumented vertebra selection. The surgeon will make the final decision after considering the model output and clinical judgment.
Annen: 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.
Fremgangsmåte: Posterior Spinal Fusion
All participants will undergo standard posterior spinal fusion using an all-pedicle screw instrumentation system.
Aktiv komparator: Conventional-Experience Group
Participants in this group will undergo standard posterior spinal fusion. The surgeon will select the lowest instrumented vertebra according to routine clinical experience and existing surgical principles. The Drum Tower Rule model output will not be provided to the surgeon for participants in this group.
Fremgangsmåte: Posterior Spinal Fusion
All participants will undergo standard posterior spinal fusion using an all-pedicle screw instrumentation system.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Distal Adding-on
Tidsramme: 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.
24 months after surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Scoliosis Research Society-22 Score
Tidsramme: 24 months after surgery
Health-related quality of life will be assessed using the Scoliosis Research Society-22 questionnaire.
24 months after surgery

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Surgery-Related Complications
Tidsramme: From surgery to 24 months after surgery
Surgery-related complications include perioperative complications, instrumentation failure, proximal junctional kyphosis, adjacent segment degeneration, pseudarthrosis, infection, and revision surgery.
From surgery to 24 months after surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. september 2030

Datoer for studieregistrering

Først innsendt

19. juli 2026

Først innsendt som oppfylte QC-kriteriene

19. juli 2026

Først lagt ut (Faktiske)

23. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juli 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • NDTH-20260578

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere