Prospective Bone Metastases Database
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasm Metastasis
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
Costantino Errani
MD, PhD.
Istituto Ortopedico Rizzoli
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
Outcomes
Primary Outcomes
Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction
Time Frame: 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 Outcomes
- Survival in patients undergoing surgery for metastatic bone disease(24 months)