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The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),
The aims of this study are to evaluate clinical and biological factors of patients with BMs after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intramedullary fixation or endoprosthetic reconstruction | Procedure | Surgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic factor regarding erythrocyte sedimentation rate | erythrocyte sedimentation rate (mm/h) | 24 months |
| Prognostic factor regarding C reactive protein | C reactive protein (mg/dl) |
Inclusion Criteria:
Exclusion Criteria:
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Patients with bone metastases in the extremities treated with intramedullary fixation or endoprosthetic recosntruction for impending fracture or pathologic fracture
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Costantino Errani, MD | Contact | +390516366103 | costantino.errani@ior.it | |
| Davide M Donati, MD | Contact | +390516366012 | davidemaria.donati@ior.it |
| Name | Affiliation | Role |
|---|---|---|
| Costantino Errani, MD | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | Bologna | 40136 | Italy |
The data will be published in the international literature at the end of the study
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 24 months |
| Prognostic factor regarding Alkaline phosphatase | Alkaline phosphatase (U/L) | 24 months |
| Prognostic factor regarding white blood cells | white blood cells (10/mm) | 24 months |
| Prognostic factor regarding hemoglobin | hemoglobin (g/dl) | 24 months |
| Prognostic factor regarding Karnofsky score | Karnofsky score (0/100) | 24 months |