Orthopedic Oncology Surgery: Navigation, Intraoperative Imaging and Virtual Reality

June 15, 2023 updated by: Regina Elena Cancer Institute
Noninterventional, prospective study of patients operated on for musculoskeletal neoplasms designed to evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00144
        • Recruiting
        • "Regina Elena" National Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with primary and secondary cancers of the musculoskeletal system with estimated survival greater than one year who are candidates for bone resection surgery or wide excision of soft tissue lesion and/or radio and chemotherapy treatments

Description

Inclusion Criteria:

  • Age: no limit
  • Patients with musculoskeletal neoplasms predominantly in complex sites
  • Patients who will have to undergo surgical resection/amputation for the management of their clinical case
  • Preparation of preoperative planning discussed at DMT
  • Surgery performed with the aid of Intraoperative CT Navigated
  • Written informed consent

Exclusion Criteria:

- Inability to perform pre-post treatment assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Popolation
Diagnostic test: evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT
Noninterventional, prospective study of patients operated on for musculoskeletal neoplasms designed to evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Baseline
To evaluate the quality of the Surgical Margin in terms of the percentage of oncologically adequate resections, in patients with Musculoskeletal neoplasms undergoing navigated resection surgery with Intraoperative CT
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Collaborators

Istituto Ortopedico Galeazzi
Azienda Policlinico Umberto I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Estimated)

May 17, 2025

Study Completion (Estimated)

November 17, 2025

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS1686/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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