Extremity boards for process optimization, evaluation, risk minimization and therapy optimization for fractures with soft tissue damage or post-operative infection of the lower extremities in the trauma network

Extremity boards for process optimization, evaluation, risk minimization and therapy optimization for fractures with soft tissue damage or post-operative infection of the lower extremities in the trauma network - EXPERT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031308

Enrollment

3366

Registered

2023-03-20

Start date

2023-05-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

S71.87 S71.88 S71.89 S81.87 S81.88 S91.88 S78 S88 S98 T84.6 T84.7

Interventions

Group 1: Adult patients requiring consent are admitted within a period of 18 months who have one of the ICD codes and who are treated in one of the participating clinics of the trauma network. Arm 1 i

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who meet at least one of the following two criteria: - Fractures of the extremities with open soft tissue damage (according to Gustilo-Anderson) or - postoperative complications (according to the criteria of the AO Anti-Infection Task Force) or unplanned re-operation within 6 months after initial surgery These criteria are operationalized via the ICD-10 codes for: - Open soft tissue damage during fractures or dislocations as well as amputations of the lower limb - Lower limb infections (excluding joints and joint endoprostheses): - Infections of joints and/or joint endoprostheses of the lower extremity: - Pseudarthrosis and delayed fracture healing of the lower limb The following prerequisites must also be met: - Consent to study participation and data transfer - Legal capacity to consent to study participation - Statutory health insurance

Exclusion criteria

Exclusion criteria: Patients who meet both of the following criteria: - No fracture of the extremities or closed fracture of the extremities without open soft tissue damage and - No postoperative complication or unplanned re-operation within 6 months after initial surgery Formal criteria - Lack of consent to study participation and data transfer - Unclear legal / consent capacity - Not covered by statutory health insurance

Design outcomes

Primary

Measure	Time frame
Either the occurrence or non-occurrence of complications is observed (dichotomous variables). The following events are considered complications if they occur within 6 months of the trauma: • Occurrence of pseudarthrosis (incomplete fracture healing) • Occurrence of chronic osteomyelitis • Unplanned follow-up procedures such as wound revisions, NPWT, etc. • deviation from the standardized antibiotic therapy (extension of the duration of therapy, change or extension of the active ingredient), • Occurrence of antibiotic-associated complications (e.g., clostridial infection, allergy, etc.) • Infection with resistant germs (e.g., MRSA) that occurred during inpatient treatment and did not exist at the time of trauma • Need for unplanned inpatient treatment • Death of the patient related to the trauma (not due to other causes)	—

Measure

Time frame

Either the occurrence or non-occurrence of complications is observed (dichotomous variables). The following events are considered complications if they occur within 6 months of the trauma: • Occurrence of pseudarthrosis (incomplete fracture healing) • Occurrence of chronic osteomyelitis • Unplanned follow-up procedures such as wound revisions, NPWT, etc. • deviation from the standardized antibiotic therapy (extension of the duration of therapy, change or extension of the active ingredient), • Occurrence of antibiotic-associated complications (e.g., clostridial infection, allergy, etc.) • Infection with resistant germs (e.g., MRSA) that occurred during inpatient treatment and did not exist at the time of trauma • Need for unplanned inpatient treatment • Death of the patient related to the trauma (not due to other causes)

—

Secondary

Measure	Time frame
Medidal, secondary outcomes • Number of antibiotics applied • Functioning of the extremities • Health-related quality of life (HRQoL) • Measured by survey instrumentse VR-36 and EQ-5D Health economical outcomes: • Use of health services • Cost of healthcare services • Inability to work (in days) • Sick pay days Work-related outcomes: • workload • job satisfaction (ressources and demands) • technology readiness / acceptance • IT ergonomics (intervention group, only)	—

Measure

Time frame

Medidal, secondary outcomes • Number of antibiotics applied • Functioning of the extremities • Health-related quality of life (HRQoL) • Measured by survey instrumentse VR-36 and EQ-5D Health economical outcomes: • Use of health services • Cost of healthcare services • Inability to work (in days) • Sick pay days Work-related outcomes: • workload • job satisfaction (ressources and demands) • technology readiness / acceptance • IT ergonomics (intervention group, only)

—

Countries

Germany

Contacts

Public ContactSteffen Roßlenbroich

Klinik für Unfall-, Hand- und Wiederherstellungschirurgie

Steffen.Rosslenbroich@ukmuenster.de+49 251 83 56301

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026