metastatic bone disease skeletal metasasis
Conditions
Interventions
Study group (A) will receive surgical treatment with PBS as an osteosynthesis
technique
study group (B) will receive an intra-medullary nail.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Aged 18 or older Expected to receive intramedullary nailing with palliative intent for a (impending) pathologic humeral fracture the due to metastatic bone disease Radiographic or histologic proof of metastatic bone disease, originating from a solid tumour or primary bone tumour Histologic diagnosis of the primary tumour or \\u2013 if the diagnosis is unknown - at least adequate diagnostic investigations into the origin of the metastasis (e.g. dissemination imaging, histology, biopsy)
Exclusion criteria
Exclusion criteria: Communication with patient is hampered (e.g. language barrier, severe cognitive impairment, dementia) The treated lesion originates from multiple myeloma, solitary plasmacytoma or lymphoma of bone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the difference in clinical functioning when comparing pre-operative measurements with 4 weeks postoperative between group A and B. The Toronto Extremity Salvage Score Upper Extremity (TESS UE) will be used. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical functioning at 8 and 12 weeks, complications at 12 weeks, pain reduction and overall quality of life at 4,8 and 12 weeks postoperative and number of admission days and blood loss are secondary endpoints. | — |
Countries
Netherlands
Outcome results
None listed