Congenital and acquired limb differences Limb differences
Conditions
Interventions
Ultrasound measurement of bone and regenerate. 
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:Patients before, during and after limb lengthening treatmentAge between 0 and 18 yearsClinic appointment at outpatient department Erasmus MC-Sophia
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:Not willing to participateRecent [<1yr] fracture of the lower limbOpen wound in the measured areaBone mineralisation disorder (acquired or congenital; e.g. Rickets, osteogenesis imperfecta)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is the quantitative comparison from changes in bone structure during consolidation after leg lengthening with ultrasound (with external fixator and nail).Acquisitions will be performed using a Vantage 256 mid-frequency scanner (Verasonics Inc., Kirkland, WA, USA) connected to a clinical cardiac phased array transducer.To characterize the structural and mechanical properties of cortical bone during different phases of limb lengthening, ultrasound measurements of radial and axial speed of sound (SOS) are acquired. These quantitative biomarkers provide insight into the anisotropic elasticity of cortical bone, which is closely linked to its microstructural composition and mineralization. Radial SOS is estimated from transverse imaging planes using an autofocusing approach that identifies the wave speed maximizing image sharpness within the cortex, while axial SOS is derived from the head wave propagating along the periosteal surface in longitudinal view. Given that axial SOS reflects the stiffness along the bone axis and radial SOS is sensitive to porosity and mineral density, their combined assessment enables evaluation of tissue quality at multiple time points before, during, and after distraction. This method builds upon previous findings showing significant correlations between SOS and bone mineral density (BMD).Speed of Sound (SOS) in bone of the treated leg (SOS_surgery_leg) will be measured with axial and radial SOS before, during and after limb lengthening (Cradial, C axial [m/s]) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurements on routine care X-rays of the affected limb obtained during their outpatient clinic appointment (in routine care these are obtained at every clinic visit before, during and after limb lengthening). Pixel intensity ratio: ratio of the pixel value of the proximal segment to that of the regeneration area Li score: describing 5 callus shapes and 10 types of feature of distraction osteogenesis Speed of Sound (SOS) in bone of contralateral leg and other segment (femur/tibia), measured similarly as on the affected/lengthened segment. (Cradial, C axial [m/s]) | — |
Countries
Netherlands
Contacts
Public ContactJ.J. Tolk
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed