Surgical Treatment of Long Bone Metastases

Surgery Clinical Trial

— MTC  

Official title:

Surgical Treatment for Long Bone Metastases With Intramedullary Nail or Endoprosthetic Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188926
• Other study ID #: 0026106
• Status: Completed
• Start date: January 4, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: August 2020
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To provide treatment guidelines for patients with long bone metastatic disease based on observational study and to propose an algorithm to guide orthopedic surgeons in decision-making for these patient.

Description:

The objectives of this study were to examine clinical outcomes 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: Completed
• Enrollment: 120
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• bone metastases of the extremity

Exclusion Criteria:

• bone metastases of the spine

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis
• Surgery

Intervention

Procedure:
• intramedullary fixation or endoprosthetic reconstruction
Surgical treatment of impending or pathologic fracture in the extremities

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
Primary	Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction	The objectives of this study were to examine clinical outcomes after reconstruction with intramedullary nail versus endoprosthetic reconstruction with a specific focus on differences in complication rate between patients treated with intramedullary nail versus endoprosthetic reconstruction	1 year
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	1 year