Bone Metastases Database of Patients Treated Surgically for Impending or Pathologic Fracture of Long Bones
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intramedullary fixation or endoprosthetic reconstruction.
- Who it may be relevant to
- Registry conditions: Neoplasm Metastasis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Bone Metastases Database
Overview
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
- Procedure intramedullary fixation or endoprosthetic reconstruction
Surgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction
Primary outcome measures
- Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction [Time frame: 24 months]
Secondary outcome measures (1)
- Survival in patients undergoing surgery for metastatic bone disease [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction
Exclusion criteria
- Patients with bone metastases of the spine
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT03416959 · 0012807