Health Condition 1: T798- Other early complications of trauma Health Condition 2: S920- Fracture of calcaneus Health Condition 3: S921- Fracture of talus Health Condition 4: S923- Fracture of metatarsal bone(s) Health Condition 5: S924- Fracture of great toe Health Condition 6: S925- Fracture of lesser toe(s) Health Condition 7: S928- Other fracture of foot, except ankle Health Condition 8: S820- Fracture of patella Health Condition 9: S821- Fracture of upper end of tibia Health Condition 10: S8
Conditions
Interventions
Intervention1: NA: NA
Sponsors
Nuvo AI Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Retrospective arm: 1. Patients greater than equal to 18 years who underwent internal fixation of bone fractures in the past 2 years or more. 2. Availability of pre-operative, intra-operative and post-operative imaging (X-ray with/without CT scans) with acceptable quality for fracture classification and size estimation. 3. Complete surgical records detailing the type, size, and configuration of implants (Meril Healthcare Pvt. Ltd.) used. 4. Availability of post-operative and follow-up data including union status, complications, or revision surgery outcomes. Prospective arm: 1. Patients greater than equal to 18 years presenting with acute fractures of bones requiring internal fixation with nails, screws, or plates. 2. Availability of digital imaging (X-ray ± CT) suitable for annotation and AI processing.
Exclusion criteria
Exclusion criteria: Retrospective arm: 1. Pathological fractures (e.g., metastatic, cystic, or osteoporotic collapse without trauma). 2. Polytrauma patients with incomplete imaging or missing clinical/surgical records. 3. Previous surgery on the same bone that alters normal anatomy or complicates implant selection. 4. Inadequate imaging quality for AI analysis or missing calibration for measurement. Prospective arm: 1. Pathological fractures or periprosthetic fractures. 2. Pediatric patients (less than 18 years) due to differing implant selection protocols. 3. Patients with incomplete imaging or poor-quality scans that do not allow proper annotation. 4. Patients refusing consent for participation in the prospective arm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To develop and validate an AI-based decision support model that recommends the optimal type, size, and configuration of nails, screws, and implants for bone fracture fixation using structured imaging and clinical data.Timepoint: 15 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate the accuracy and reliability of AI-generated implant recommendations compared to the treating surgeonâ??s decision. â?¢ To assess clinical outcomes, including fracture union, implant related complications, and the need for revision surgeries, in cases where AI recommendations are applied. â?¢ To measure the efficiency and utility of the AI tool in real-world orthopaedic workflows, including its impact on decision-making time. â?¢ To establish a standardized, data-driven framework for implant selection that can reduce inter-surgeon variability and improve patient outcomes.Timepoint: 15 months | — |
Countries
India
Contacts
Public ContactMs Shikha Shah
Nuvo AI Pvt. Ltd
Outcome results
None listed