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Ultrasound in the Diagnosis and Management of Pediatric Osteomyelitis and the Development of a Clinical Prediction Model

Ultrasound in the Diagnosis and Management of Pediatric Osteomyelitis and the Development of a Clinical Prediction Model

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123555
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Pediatric osteomyelitis

Interventions

Suspected osteomyelitis cases:None
Confirmed cases of osteomyelitis in children and a considerable number of control groups:None

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age: Children and adolescents aged from 1 month to 18 years. 2. Clinically Suspected Acute Osteomyelitis: Meeting at least two of the following criteria: (1) Local bone pain, tenderness, or limited movement; (2) Fever > 38.5°C; (3) Serum C-reactive protein (CRP) > 20 mg/L or erythrocyte sedimentation rate (ESR) > 20 mm/h. 3. Imaging Evaluation: Underwent ultrasound examination of the affected bone during the diagnostic and treatment process. 4. Definite Final Diagnosis: Patients were categorized into a "confirmed group" and a "control (non-osteomyelitis) group" based on the final clinical diagnosis (gold standard). Gold Standard Definition: (1) Confirmed Group: Diagnosis of acute osteomyelitis confirmed by MRI and/or pus culture from surgery/aspiration, or confirmed by complete clinical and radiological recovery following standard antibiotic treatment; (2) Control Group: Children with initial suspicion but ultimately ruled out for osteomyelitis, diagnosed with conditions such as cellulitis, septic arthritis, trauma, or bone tumors, and confirmed by subsequent follow-up (of at least 1 month).

Exclusion criteria

Exclusion criteria: 1. Chronic osteomyelitis (symptom duration >= 3 months), post-traumatic or postoperative osteomyelitis. 2. Presence of other active severe infections (such as septic shock), immunodeficiency diseases, malignant tumors, or autoimmune diseases. 3. Missing or incomplete key clinical, laboratory, or imaging data. 4. Poor quality ultrasound images in retrospective cases, making re-analysis and scoring impossible.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Positive Predictive Value;Negative Predictive Value;Positive Likelihood Ratio;Negative Likelihood Ratio;Area Under the Receiver Operating Characteristic Curve;Calibration (Calibration Curve, Hosmer-Lemeshow Test);Clinical Utility (Decision Curve Analysis);

Countries

China

Contacts

Public ContactLu Hongxu, Tang Xiaoli

Children's Hospital of Chongqing Medical University

luhongxu2013@163.com+86 23 63632064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026