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 | Completed DMC

• 1 other identifier: RC15_0097
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 8

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.

Conditions

Sarcoma, Bone Tumor

Keywords

Pelvis; Surgical resection; Patient specific instrument

Outcome Measures

Primary Outcomes (1)

• ICER between the innovation treatment group and the reference treatment group.

  Incremental Cost-Effectiveness Ratio (ICER) as assessed from the healthcare system perspective: Cost/Local prevented recurrence at 3 years postoperatively

  3 years

Secondary Outcomes (6)

• R0, R1 and R2 margin rates

  Within 3 years after surgery

• Rate and nature of adverse events related to surgery for each treatment group

  Per-operatively and within 3 years after surgery

• Quality Of Life (QOL) of patients treated by PSI (prospective group)

  0, 6, 12, 18, 24, 30 and 36 months

• Indirect estimations of means of Quality Adjusted Life Years (QALYs) of patients treated by the reference treatment (retrospective group) extrapolated from QOL of patients treated by PSI (prospective group)

  3 years

• MSTS score

  12 and 36 months

Study Arms (2)

Prospective group :Innovation

EXPERIMENTAL

Surgical treatment using a patient specific instrument (PSI)

Device: Patient specific instrument

Retrospective group: Reference

OTHER

Conventional surgical treatment without PSI, using 2D imaging planification

Procedure: Conventional surgical treatment

Interventions

Patient specific instrument 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.

Also known as: PSI-T, 3D-Side

Prospective group :Innovation

Conventional surgical treatment PROCEDURE

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

Retrospective group: Reference

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (8)

Lille University Hospital

Lille, France

Location

Lyon Centre Léon Bérard

Lyon, France

Location

Lyon CRCM Les Massues

Lyon, France

Location

Marseille University Hospital

Marseille, France

Location

Nancy Centre Chirurgical Emile Gallé

Nancy, France

Location

Nantes University Hospital

Nantes, 44000, France

Location

Paris Hospital Cochin

Paris, France

Location

Paris Hospital Kremlin-Bicêtre

Paris, France

Location

MeSH Terms

Conditions

Sarcoma; Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Study Officials

• François Gouin, Professor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 9, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

FR (8)