Adolescent Idiopathic ScoliosisNCT07723053
Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis
A study testing Drum Tower Rule Machine Learning-Guided Decision Support, Conventional LIV Decision-Making and Posterior Spinal Fusion in people with Adolescent Idiopathic Scoliosis and Lenke Type 1 Adolescent Idiopathic Scoliosis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Lenke Type 1 Adolescent Idiopathic Scoliosis, Lenke Type 5 Adolescent Idiopathic Scoliosis
- What is being tested?
- Drum Tower Rule Machine Learning-Guided Decision Support, Conventional LIV Decision-Making and Posterior Spinal Fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Xiaodong Qin, MD, PhD, 025-68182923, gyethics@163.com
About this study
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
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.
Read the detailed description
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.
- Conditions
- Adolescent Idiopathic Scoliosis, Lenke Type 1 Adolescent Idiopathic Scoliosis, Lenke Type 5 Adolescent Idiopathic Scoliosis
- Being tested
- Drum Tower Rule Machine Learning-Guided Decision Support, Conventional LIV Decision-Making, Posterior Spinal Fusion
- Keywords
- Lowest Instrumented Vertebra, Distal Adding-on, Machine Learning, Surgical Decision Support, Posterior Spinal Fusion, Lenke Classification, Drum Tower Rule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drum Tower Rule Machine Learning-Guided Decision SupportOther
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-MakingOther
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 FusionProcedure or surgery
All participants will undergo standard posterior spinal fusion using an all-pedicle screw instrumentation system.
| Study group | Role | What they receive |
|---|---|---|
| Model-Guided Group | Experimental | 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. Receives: Other: Drum Tower Rule Machine Learning-Guided Decision Support; Procedure: Posterior Spinal Fusion |
| Conventional-Experience Group | Active comparator | 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. Receives: Other: Conventional LIV Decision-Making; Procedure: Posterior Spinal Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Distal Adding-on
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.
Measured: 24 months after surgery
Secondary outcomes (1)
Scoliosis Research Society-22 Score
Health-related quality of life will be assessed using the Scoliosis Research Society-22 questionnaire.
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned in a 1:1 ratio to either the model-guided group or the conventional-experience group. Randomization will be stratified by Lenke classification. Both groups will undergo standard posterior spinal fusion; the difference between groups is the method used to support lowest instrumented vertebra selection.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723053
- Sponsor's protocol ID
- NDTH-20260578
- Status last verified
- May 2026
- First submitted
- 19 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3.
PubMed 18456103Lenke LG, Betz RR, Harms J, Bridwell KH, Clements DH, Lowe TG, Blanke K. Adolescent idiopathic scoliosis: a new classification to determine extent of spinal arthrodesis. J Bone Joint Surg Am. 2001 Aug;83(8):1169-81.
PubMed 11507125
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07723053
- Acronym / sponsor ID
- NDTH-20260578
- Conditions
- Adolescent Idiopathic Scoliosis, Lenke Type 1 Adolescent Idiopathic Scoliosis, Lenke Type 5 Adolescent Idiopathic Scoliosis
- Keywords
- Lowest Instrumented Vertebra, Distal Adding-on, Machine Learning, Surgical Decision Support, Posterior Spinal Fusion, Lenke Classification, Drum Tower Rule
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned in a 1:1 ratio to either the model-guided group or the conventional-experience group. Randomization will be stratified by Lenke classification. Both groups will undergo standard posterior spinal fusion; the difference between groups is the method used to support lowest instrumented vertebra selection.
| Arm | Type | Receives |
|---|---|---|
| Model-Guided Group | Experimental | Other: Drum Tower Rule Machine Learning-Guided Decision Support, Procedure: Posterior Spinal FusionParticipants 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. |
| Conventional-Experience Group | Active comparator | Other: Conventional LIV Decision-Making, Procedure: Posterior Spinal FusionParticipants 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drum Tower Rule Machine Learning-Guided Decision SupportA 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 | Model-Guided Group |
| Conventional LIV Decision-MakingThe 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. | Other | Conventional-Experience Group |
| Posterior Spinal FusionAll participants will undergo standard posterior spinal fusion using an all-pedicle screw instrumentation system. | Procedure or surgery | Conventional-Experience Group, Model-Guided Group |
Primary outcome
Incidence of Distal Adding-on
Time frame: 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.
1 secondary outcome
Scoliosis Research Society-22 Score
Time frame: 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 18456103Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3.
- Background: PubMed 11507125Lenke LG, Betz RR, Harms J, Bridwell KH, Clements DH, Lowe TG, Blanke K. Adolescent idiopathic scoliosis: a new classification to determine extent of spinal arthrodesis. J Bone Joint Surg Am. 2001 Aug;83(8):1169-81.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drum Tower Rule Machine Learning-Guided Decision Support, Conventional LIV Decision-Making and Posterior Spinal Fusion in people with Adolescent Idiopathic Scoliosis and Lenke Type 1 Adolescent Idiopathic Scoliosis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Qin, MD, PhD (025-68182923, gyethics@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Distal Adding-on (time frame: 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07723053, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.