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Bone Metastases Database of Patients Treated Surgically for Impending or Pathologic Fracture of Long Bones

ConditionNeoplasm Metastasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorIstituto Ortopedico Rizzoli

About this trial

The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction

Disqualifiers

Patients with bone metastases of the spine

Trial population

Patients with bone metastases in the extremities treated with intramedullary fixation or endoprosthetic recosntruction for impending fracture or pathologic fracture

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • intramedullary fixation or endoprosthetic reconstruction

    Procedure/Surgery

    Surgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction

The study includes the collection of clinical data (age, sex, Karnofsky score) and laboratory data related to the patient (erythrocyte sedimentation rate, C reactive protein, Alkaline phosphatase, white blood cells and hemoglobin) at the time of admission, data on the pathology (histotype, site of bone metastasis , presence of further skeletal or visceral metastases), type of surgery performed (stabilization versus resection).The objectives of this study is to examine clinical outcomes after after surgical treatment of bone metastases with a specific focus on differences in complication rate between patients treated with intramedullary nail versus endoprosthetic reconstruction

Time frame
24 months

Secondary outcomes

1

Survival in patients undergoing surgery for metastatic bone disease

Provide a reliable and objective means of estimating survival in patients with metastatic bone disease based on disease-specific and laboratory tests

Time frame
24 months

Other outcomes

1

Prognostic factor regarding erythrocyte sedimentation rate

erythrocyte sedimentation rate (mm/h)

Time frame
24 months
2

Prognostic factor regarding C reactive protein

C reactive protein (mg/dl)

Time frame
24 months
3

Prognostic factor regarding Alkaline phosphatase

Alkaline phosphatase (U/L)

Time frame
24 months
4

Prognostic factor regarding white blood cells

white blood cells (10/mm)

Time frame
24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Ortopedico Rizzoli

Lead sponsor

Source ClinicalTrials.gov
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