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 (MARGIC)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Sarcoma, Bone Tumor

Treatments: Device: Patient specific instrument; Procedure: Conventional surgical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02544711

RC15_0097

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Screening Critieria:

Retrospective group (reference)

• Patient already operated for the same indication as detailed in the prospective group 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

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Prospective group :Innovation

Experimental group

Description:

Surgical treatment using a patient specific instrument (PSI)

Treatment:

Device: Patient specific instrument

Retrospective group: Reference

Other group

Description:

Conventional surgical treatment without PSI, using 2D imaging planification

Treatment:

Procedure: Conventional surgical treatment