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)

July 27, 2021 updated by: Nantes University Hospital

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lille, France
        • Lille University Hospital
      • Lyon, France
        • LYON Centre Léon Bérard
      • Lyon, France
        • Lyon CRCM Les Massues
      • Marseille, France
        • Marseille University Hospital
      • Nancy, France
        • Nancy Centre Chirurgical Emile Gallé
      • Nantes, France, 44000
        • Nantes University Hospital
      • Paris, France
        • Paris Hospital Cochin
      • Paris, France
        • Paris Hospital Kremlin-Bicêtre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Prospective group :Innovation
Surgical treatment using a patient specific instrument (PSI)
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.
Other Names:
  • PSI-T
  • 3D-Side
OTHER: Retrospective group: Reference
Conventional surgical treatment without PSI, using 2D imaging planification
The conventional treatment is planned on two-dimensional images (CT and MRI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICER between the innovation treatment group and the reference treatment group.
Time Frame: 3 years
Incremental Cost-Effectiveness Ratio (ICER) as assessed from the healthcare system perspective: Cost/Local prevented recurrence at 3 years postoperatively
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0, R1 and R2 margin rates
Time Frame: Within 3 years after surgery
R0, R1 and R2 margin rates as observed by histological exam for each surgical treatment, for each treatment group.
Within 3 years after surgery
Rate and nature of adverse events related to surgery for each treatment group
Time Frame: Per-operatively and within 3 years after surgery
Per-operatively and within 3 years after surgery
Quality Of Life (QOL) of patients treated by PSI (prospective group)
Time Frame: 0, 6, 12, 18, 24, 30 and 36 months
Euroqol questionnaire score
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)
Time Frame: 3 years
QALYs measures for this group will be extrapolated from the prospective group by estimating the impact of a local recurrence on health-related quality of life.
3 years
MSTS score
Time Frame: 12 and 36 months
Musculoskeletal Tumor Society (MSTS) Score which evaluates 6 items: pain, function, emotional acceptance, walking capacity, technical walking aids, gait.
12 and 36 months
TESS Score
Time Frame: 12 and 36 months
Toronto Extremity Salvage Score (TESS) which evaluates 30 items about the global function and patient's activity level.
12 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: François Gouin, Professor, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ACTUAL)

May 1, 2021

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (ESTIMATE)

September 9, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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