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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

NCT02544711 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-07-28

No results posted yet for this study

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.

Conditions

  • Sarcoma, Bone Tumor

Interventions

DEVICE

Patient specific instrument

The proposed innovation consists in using patient specific instrument (PSI) for tumor resection. It is compounded of a preoperative assistance to plan the surgery and an intraoperative assistance to reproduce the preoperative planning.

PROCEDURE

Conventional surgical treatment

The conventional treatment is planned on two-dimensional images (CT and MRI).

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • François Gouin, Professor · Nantes University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544711 on ClinicalTrials.gov