- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02544711
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)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France
- Lille University Hospital
-
Lyon, France
- LYON Centre Léon Bérard
-
Lyon, France
- Lyon CRCM Les Massues
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Marseille, France
- Marseille University Hospital
-
Nancy, France
- Nancy Centre Chirurgical Emile Gallé
-
Nantes, France, 44000
- Nantes University Hospital
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Paris, France
- Paris Hospital Cochin
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Paris, France
- Paris Hospital Kremlin-Bicêtre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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):
- 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
Study Plan
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:
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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
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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
Sponsor
Investigators
- Principal Investigator: François Gouin, Professor, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC15_0097
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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