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Clinical Trial Summary

Primitive malignant bone tumor or mixt tumor (compounded of soft tissues and bone) is a rare pathology particularly within the pelvis, the sacrum or the hip (between 25 and 80 new cases in France per year). The reference treatment is a surgical "en bloc" resection associated or not to a medical treatment. This surgery remains highly challenging because of the complex three-dimensional geometry of the pelvic bone and the proximity of important organs and neurovascular structures. The local recurrence rate is significantly increased when the resection does not respect a safe tissues margin (R0 margin). A new technology has been developed and used in different reference sites the Patient Specific Instrument (PSI), manufactured by 3D-Side. The PSI allows for a more secure and reliable surgical gesture, leading to more frequent R0 margins. The main objective of this study is to compare the efficiency of the PSI for bone tumor resections within the pelvis with respect to the reference method.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT02544711
Study type Interventional
Source Nantes University Hospital
Contact
Status Completed
Phase N/A
Start date December 2015
Completion date May 2021