M84.1
Conditions
Interventions
Group 1: intervention group: daily treatment with low-intensity pulsed ultrasound for 200 days, at minimum 180 days (compliance 90%)
Group 2: control group: surgery of the non-union in accordance with
Sponsors
Universitätsklinikum Essen AöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - non-union of the upper or lower extremity including clavicle - fracture > 6 months and < 24 months - primary osteosynthesis of the fracture - bony defect < 1 cm - closed soft tissue - signed informed consent - health insurance by law
Exclusion criteria
Exclusion criteria: - instability of the non-union - non-union of the spine or the cranium - non-union of the small bones of the hand or the toes - non-union after osteotomy - long spiral fractures - pathological fractures due to maligne tumors or metastases - operation within the last 4 months - infection/osteomyelitis of the non-union, defects of soft tissue - therapy with cytostatic drugs - pacemaker - pregnancy/breast feeding - comorbidity, which influences the compliance - participation in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fracture healing after 12 months (bony consolidation as well as functional restoration; composite endpoint) | — |
Secondary
| Measure | Time frame |
|---|---|
| - time to fracture healing - time to full weight bearing - intensity of pain - functional complaints, activities of daily living - quality of life - complications - (serious) adverse events - incidence of re-operation - duration of hospital stay - length of inability to work | — |
Countries
Germany
Outcome results
None listed