Photodynamic Bone Stabilization for the treatment of (impending) pathological humeral fractures in patients with bone metastases

Conditions: metastatic bone disease
skeletal metasasis
10028389

Registration Number: NL-OMON48995

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 36

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the difference in clinical functioning when comparing<br /><br>pre-operative measurements with 4 weeks postoperative between group A and B.<br /><br>The Toronto Extremity Salvage Score Upper Extremity (TESS UE) will be used.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical functioning at 8 and 12 weeks, complications at 12 weeks, pain<br /><br>reduction and overall quality of life at 4,8 and 12 weeks postoperative and<br /><br>number of admission days and blood loss are secondary endpoints.</p><br>