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

Neoplasm Metastasis Clinical Trial

— BMD  

Official title:

Prospective Bone Metastases Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03416959
• Other study ID #: 0012807
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Costantino Errani, MD
• Phone: +390516366103
• Email: costantino.errani[@]ior.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with bone metastases of the spine

Related Conditions & MeSH terms

• Neoplasm Metastasis

Intervention

Procedure:
• intramedullary fixation or endoprosthetic reconstruction
Surgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prognostic factor regarding erythrocyte sedimentation rate	erythrocyte sedimentation rate (mm/h)	24 months
Other	Prognostic factor regarding C reactive protein	C reactive protein (mg/dl)	24 months
Other	Prognostic factor regarding Alkaline phosphatase	Alkaline phosphatase (U/L)	24 months
Other	Prognostic factor regarding white blood cells	white blood cells (10/mm)	24 months
Other	Prognostic factor regarding hemoglobin	hemoglobin (g/dl)	24 months
Other	Prognostic factor regarding Karnofsky score	Karnofsky score (0/100)	24 months
Primary	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	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