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Spots Global Cancer Trial Database for Cost-effectiveness Evaluation of the Use of a Patient Specific Instrument for Surgical Resection of Malignant Bone Tumor Within the Pelvis Versus the Conventional Surgical Treatment

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Trial Identification

Brief Title: Cost-effectiveness Evaluation of the Use of a Patient Specific Instrument for Surgical Resection of Malignant Bone Tumor Within the Pelvis Versus the Conventional Surgical Treatment

Official Title: Cost-effectiveness Evaluation of the Use of a Patient Specific Instrument for Surgical Resection of Malignant Bone Tumor Within the Pelvis Versus the Conventional Surgical Treatment

Study ID: NCT02544711

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Lille University Hospital, Lille, , France

Lyon Centre Léon Bérard, Lyon, , France

Lyon CRCM Les Massues, Lyon, , France

Marseille University Hospital, Marseille, , France

Nancy Centre Chirurgical Emile Gallé, Nancy, , France

Nantes University Hospital, Nantes, , France

Paris Hospital Cochin, Paris, , France

Paris Hospital Kremlin-Bicêtre, Paris, , France

Contact Details

Name: François Gouin, Professor

Affiliation: Nantes University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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