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

NCT03416959 | Recruiting

• 1 other identifier: 0012807
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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),

Conditions

Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Survival in patients undergoing surgery for metastatic bone disease

  24 months

Other Outcomes (6)

• Prognostic factor regarding erythrocyte sedimentation rate

  24 months

• Prognostic factor regarding C reactive protein

  24 months

• Prognostic factor regarding Alkaline phosphatase

  24 months

Interventions

intramedullary fixation or endoprosthetic reconstruction PROCEDURE

Surgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Patients with bone metastases of the spine

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Costantino Errani, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Costantino Errani, MD

CONTACT

+390516366103; costantino.errani@ior.it

Davide M Donati, MD

CONTACT

+390516366012; davidemaria.donati@ior.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 31, 2018
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)