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

NCT ID: NCT03416959

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Neoplasm Metastasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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intramedullary fixation or endoprosthetic reconstruction

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with bone metastases of the spine
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Costantino Errani

MD, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Costantino Errani, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

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Istituto Ortopedico Rizzoli

Bologna, Bologna, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Costantino Errani, MD

Role: CONTACT

+390516366103

Davide M Donati, MD

Role: CONTACT

+390516366012

Facility Contacts

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Costantino Errani, MD, PhD

Role: primary

0039 051 6366103

Davide Donati, MD

Role: backup

0039 051 6366012

Other Identifiers

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0012807

Identifier Type: -

Identifier Source: org_study_id

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