NCT03188926

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

June 9, 2017

Last Update Submit

August 2, 2020

Conditions

Bone MetastasesSurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Survival in patients undergoing surgery for metastatic bone disease

    1 year

Interventions

intramedullary fixation or endoprosthetic reconstructionPROCEDURE

Surgical treatment of impending or pathologic fracture in the extremities

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • bone metastases of the extremity

You may not qualify if:

  • bone metastases of the spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Study Officials

  • Davide Donati, MD

    Istituto Ortopedico Rizzoli

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 16, 2017

Study Start

January 4, 2016

Primary Completion

December 31, 2017

Study Completion

January 31, 2020

Last Updated

August 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

publish a manuscript in international journal

Locations

IT(1)