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

Prospective Bone Metastases Database

The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),

Study Overview

• Status: Recruiting
• Conditions: Neoplasm Metastasis
• Intervention / Treatment: Procedure: intramedullary fixation or endoprosthetic reconstruction

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Costantino Errani, MD; Phone Number: +390516366103; Email: costantino.errani@ior.it
• Study Contact Backup: Name: Davide M Donati, MD; Phone Number: +390516366012; Email: davidemaria.donati@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Costantino Errani, MD, PhD; Phone Number: 0039 051 6366103; Email: costantino.errani@ior.it
    • Contact: Davide Donati, MD; Phone Number: 0039 051 6366012; Email: davidemaria.donati@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with bone metastases in the extremities treated with intramedullary fixation or endoprosthetic recosntruction for impending fracture or pathologic fracture

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Costantino Errani, MD, Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 31, 2027
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 0012807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be published in the international literature at the end of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No