Surgical Treatment of Long Bone Metastases

NCT ID: NCT03188926

Last Updated: 2020-08-04

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

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-04

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bone Metastases Surgery

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 of impending or pathologic fracture in the extremities

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* bone metastases of the extremity

Exclusion Criteria

* 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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Davide Donati, MD

Role: STUDY_DIRECTOR

Istituto Ortopedico Rizzoli

Locations

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Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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0026106

Identifier Type: -

Identifier Source: org_study_id

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