Neoplasm Metastasis
Conditions
Brief summary
The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),
Detailed description
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.
Interventions
Surgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction
Sponsors
Istituto Ortopedico Rizzoli
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction
Exclusion criteria
* Patients with bone metastases of the spine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival in patients undergoing surgery for metastatic bone disease | 24 months | Provide a reliable and objective means of estimating survival in patients with metastatic bone disease based on disease-specific and laboratory tests |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prognostic factor regarding Alkaline phosphatase | 24 months | Alkaline phosphatase (U/L) |
| Prognostic factor regarding white blood cells | 24 months | white blood cells (10/mm) |
| Prognostic factor regarding erythrocyte sedimentation rate | 24 months | erythrocyte sedimentation rate (mm/h) |
| Prognostic factor regarding Karnofsky score | 24 months | Karnofsky score (0/100) |
| Prognostic factor regarding hemoglobin | 24 months | hemoglobin (g/dl) |
| Prognostic factor regarding C reactive protein | 24 months | C reactive protein (mg/dl) |
Countries
Italy
Contacts
Primary ContactCostantino Errani, MD
Backup ContactDavide M Donati, MD
Outcome results
None listed