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

Recruiting

• Conditions: Neoplasm Metastasis

• Registration Number: NCT03416959
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• Patients with bone metastases of the spine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy