search
Back to results

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)

Primary Purpose

Sarcoma, Bone Tumor

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient specific instrument
Conventional surgical treatment
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Bone Tumor focused on measuring Pelvis, Surgical resection, Patient specific instrument

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Prospective group :Innovation

Retrospective group: Reference

Arm Description

Surgical treatment using a patient specific instrument (PSI)

Conventional surgical treatment without PSI, using 2D imaging planification

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

R0, R1 and R2 margin rates
R0, R1 and R2 margin rates as observed by histological exam for each surgical treatment, for each treatment group.
Rate and nature of adverse events related to surgery for each treatment group
Quality Of Life (QOL) of patients treated by PSI (prospective group)
Euroqol questionnaire score
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)
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.
MSTS score
Musculoskeletal Tumor Society (MSTS) Score which evaluates 6 items: pain, function, emotional acceptance, walking capacity, technical walking aids, gait.
TESS Score
Toronto Extremity Salvage Score (TESS) which evaluates 30 items about the global function and patient's activity level.

Full Information

First Posted
August 24, 2015
Last Updated
July 27, 2021
Sponsor
Nantes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02544711
Brief Title
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
Acronym
MARGIC
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Bone Tumor
Keywords
Pelvis, Surgical resection, Patient specific instrument

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective group :Innovation
Arm Type
Experimental
Arm Description
Surgical treatment using a patient specific instrument (PSI)
Arm Title
Retrospective group: Reference
Arm Type
Other
Arm Description
Conventional surgical treatment without PSI, using 2D imaging planification
Intervention Type
Device
Intervention Name(s)
Patient specific instrument
Other Intervention Name(s)
PSI-T, 3D-Side
Intervention Description
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
Procedure
Intervention Name(s)
Conventional surgical treatment
Intervention Description
The conventional treatment is planned on two-dimensional images (CT and MRI).
Primary Outcome Measure Information:
Title
ICER between the innovation treatment group and the reference treatment group.
Description
Incremental Cost-Effectiveness Ratio (ICER) as assessed from the healthcare system perspective: Cost/Local prevented recurrence at 3 years postoperatively
Time Frame
3 years
Secondary Outcome Measure Information:
Title
R0, R1 and R2 margin rates
Description
R0, R1 and R2 margin rates as observed by histological exam for each surgical treatment, for each treatment group.
Time Frame
Within 3 years after surgery
Title
Rate and nature of adverse events related to surgery for each treatment group
Time Frame
Per-operatively and within 3 years after surgery
Title
Quality Of Life (QOL) of patients treated by PSI (prospective group)
Description
Euroqol questionnaire score
Time Frame
0, 6, 12, 18, 24, 30 and 36 months
Title
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)
Description
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.
Time Frame
3 years
Title
MSTS score
Description
Musculoskeletal Tumor Society (MSTS) Score which evaluates 6 items: pain, function, emotional acceptance, walking capacity, technical walking aids, gait.
Time Frame
12 and 36 months
Title
TESS Score
Description
Toronto Extremity Salvage Score (TESS) which evaluates 30 items about the global function and patient's activity level.
Time Frame
12 and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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): 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). 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Gouin, Professor
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lille University Hospital
City
Lille
Country
France
Facility Name
Lyon Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Lyon CRCM Les Massues
City
Lyon
Country
France
Facility Name
Marseille University Hospital
City
Marseille
Country
France
Facility Name
Nancy Centre Chirurgical Emile Gallé
City
Nancy
Country
France
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Paris Hospital Cochin
City
Paris
Country
France
Facility Name
Paris Hospital Kremlin-Bicêtre
City
Paris
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs