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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sarcoma, Bone Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prospective group :Innovation

Surgical treatment using a patient specific instrument (PSI)

Group Type EXPERIMENTAL

Patient specific instrument

Intervention Type DEVICE

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.

Retrospective group: Reference

Conventional surgical treatment without PSI, using 2D imaging planification

Group Type OTHER

Conventional surgical treatment

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DEVICE

Conventional surgical treatment

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

Intervention Type PROCEDURE

Other Intervention Names

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PSI-T 3D-Side

Eligibility Criteria

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Inclusion Criteria

* Surgery date within the 6 years before the study activation in the participating center
* Adult (18 years old or more) at the time of surgery

Prospective group (innovation)

* Primitive malignant pelvic bone tumor or mixt tumor (primary bone sarcoma, soft tissue sarcoma with bone extension, giant cells tumor of bone and any tumor requiring such a resection)
* Indication for a wide monobloc resection according to clinical guidelines of the pathology ("en bloc" resection of iliac bone including a bone section from periacetabular Enneking zone 2 to the sacrum zone 4, hip extra-articular resection for proximal femur tumors and sacral tumor or ilio-sacral tumors that need a vertical osteotomy or horizontal osteotomy above S2)
* Ability to fill in Euroqol and TESS questionnaires
* Adult (18 years old or more)
* Health insurance holder

Retrospective group (reference)

Patient fulfilling the matching criteria with one patient of the prospective group, according to the following matching criteria (in order of importance):

1. Tumor location (Enneking zones 1, 2, 1-2, 2-3, 1-2-3, 1-2-4, 1-2-3-4, 1-4, sacrum)
2. Tumor type (chondrosarcoma, osteosarcoma, Ewing, chordoma, other tumor type)
3. Surgery center
4. Tumor size (as close as possible between both patients)
5. Response to chemotherapy (good, bad, not applicable).

Exclusion Criteria

Prospective group (innovation)

* Patient suffering from a local recurrence or a metastasis at recruitment time
* Absence of informed consent
* Pregnancy or breastfeeding
* Minors
* Adults under guardianship or trusteeship

Retrospective group (reference)

* Patient not fulfilling the protocol matching criteria
* Refusal to participate

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No