Fracture Healing Assistant

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039537

Enrollment

5000

Registered

2026-03-11

Start date

2025-10-01

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

S72 S82

Interventions

Group 1: retrospective analysis of patients with a fracture of long bones (tibia, femur, humerus) that were treated between January 1st, 2010 to December 31st 2024

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Fracture of a long bone (femur, tibia, humerus) in the past - Availability of at least two radiographs in two planes each over the course of healing - Known fracture healing outcome: healed vs. delayed union/non-union - Inclusion of multiple fractures in different long bones is possible; each fracture is counted as a separate case

Exclusion criteria

Exclusion criteria: - Poor radiograph quality preventing evaluation, if fewer than two assessable image sets are available - Presence of prior fractures, cysts, or tumors in the same bone - Two or more acute fractures in the same long bone captured in the same radiograph

Design outcomes

Primary

Measure	Time frame
What is the prognostic accuracy (sensitivity and specificity) of the RUS score (Radiographic Union Score) 8 weeks after fracture for distinguishing between patients with fracture union and non-union in fresh fractures of the femur, tibia, and humerus?	—

Secondary

Measure	Time frame
- What is the influence of health-related and sociodemographic factors on the prognostic accuracy, as assessed by the RUS score, including sex, age, weight, height, ethnicity, comorbidities, and smoking status? - How does the timing of imaging affect the statistical analysis of the prognostic performance of the RUS score in relation to treatment outcomes? - What is the interrater variability between trauma surgeons and radiologists with regard to RUS score assessments? - Can existing scoring systems, primarily developed for diaphyseal fractures, be reliably applied to fractures outside the shaft region? - Is it feasible to automatically extract RUS score values from radiographic images? - Can an automated method provide reliable prediction of fracture healing? - What validation measures are required to verify the obtained RUS score values?	—

Measure

Time frame

- What is the influence of health-related and sociodemographic factors on the prognostic accuracy, as assessed by the RUS score, including sex, age, weight, height, ethnicity, comorbidities, and smoking status? - How does the timing of imaging affect the statistical analysis of the prognostic performance of the RUS score in relation to treatment outcomes? - What is the interrater variability between trauma surgeons and radiologists with regard to RUS score assessments? - Can existing scoring systems, primarily developed for diaphyseal fractures, be reliably applied to fractures outside the shaft region? - Is it feasible to automatically extract RUS score values from radiographic images? - Can an automated method provide reliable prediction of fracture healing? - What validation measures are required to verify the obtained RUS score values?

—

Countries

Germany

Contacts

Public ContactArndt-Peter Schulz

Berufsgenossenschaftliches Klinikum Hamburg

schulz@biomechatronics.de07306 40418

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026