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AI-assisted follow-up combined with a red-flag escalation mechanism for postoperative management of osteoporotic vertebral compression fractures: a single-centre randomized controlled trial

AI-assisted follow-up combined with a red-flag escalation mechanism for postoperative management of osteoporotic vertebral compression fractures: a single-centre randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112626
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporotic vertebral compression fracture

Interventions

AI-assisted Follow-up Group:AI-assisted follow-up with red-flag escalation mechanism
Conventional (Human-led) Follow-up Group:Conventional follow-up/education with red-flag escalation mechanism

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >= 60 years; 2. Imaging confirms OVCF, has undergone PVP/PKP/posterior fixation, and postoperative period <= 7 days; 3. Planned to receive alendronate (oral) or denosumab (subcutaneous injection); 4. Patient or primary caregiver has the ability to participate in WeChat follow-up; 5. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. History of or concurrent malignant tumors, or severe liver/kidney dysfunction; 2. Severe cognitive/mental disorders (e.g., MMSE <=18) preventing cooperation; 3. Expected lifespan <12 months or extremely unstable condition; 4. Contraindication or allergy to alendronate/denosumab; 5. No reliable contact information or expected inability to complete 12-month follow-up.

Design outcomes

Primary

MeasureTime frame
12-month adherence for oral alendronate (PDC >=80%);On-time denosumab dosing (both doses within 6-month ±4-week windows);

Secondary

MeasureTime frame
Pain intensity (VAS, 0–100 mm);Oswestry Disability Index (ODI, %);Fracture-Related Index (FRI, %);Mean duration of follow-up encounter;Cumulative fall incidence;Follow-up response rateFollow-up response rate;Patient satisfaction (5-point Likert scale);Escalation rate of red-flag events to human intervention;Cumulative all-cause readmission rate;Rate of clinician edits to AI responses;Cumulative refracture incidence;

Countries

China

Contacts

Public ContactHao Jie

The First Affiliated Hospital of Chongqing Medical University

hjie2005@aliyun.com+86 195 6221 6963

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026