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NCT05918536 Clinical Trial

Orthopedic Oncology Surgery: Navigation, Intraoperative Imaging and Virtual Reality

Neoplasms Clinical Trial

Official title:
Orthopedic Oncology Surgery: Navigation, Intraoperative Imaging and Virtual Reality

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05918536
Other study ID # RS1686/22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 17, 2022
Est. completion date November 17, 2025

Study information
Verified date June 2023
Source Regina Elena Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 45
Est. completion date November 17, 2025
Est. primary completion date May 17, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy "Regina Elena" National Cancer Institute Rome

Sponsors (3)
Lead Sponsor Collaborator
Regina Elena Cancer Institute Azienda Policlinico Umberto I, Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life 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
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