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)
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|ClinicalTrials.gov Identifier: NCT02544711|
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : September 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma, Bone Tumor||Device: Patient specific instrument Procedure: Conventional surgical treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 2015|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Prospective group :Innovation
Surgical treatment using a patient specific instrument (PSI)
Device: Patient specific instrument
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.
Retrospective group: Reference
Conventional surgical treatment without PSI, using 2D imaging planification
Procedure: Conventional surgical treatment
The conventional treatment is planned on two-dimensional images (CT and MRI).
- 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
- 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.
- Rate and nature of adverse events related to surgery for each treatment group [ Time Frame: 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
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544711
|Contact: François Gouin, Professor||+33 2 40 08 48 firstname.lastname@example.org|
|Lille University Hospital||Recruiting|
|Contact: Carlos MAYNOU email@example.com|
|Principal Investigator: Carlos MAYNOU|
|Lyon Centre Léon Bérard||Recruiting|
|Contact: Gualter VAZ firstname.lastname@example.org|
|Principal Investigator: Gualter VAZ|
|Lyon CRCM Les Massues||Recruiting|
|Contact: Gualter VAZ email@example.com|
|Principal Investigator: Gualter VAZ|
|Marseille University Hospital||Recruiting|
|Contact: Alexandre ROCHWERGER firstname.lastname@example.org|
|Principal Investigator: Alexandre ROCHWERGER|
|Nancy Centre Chirurgical Emile Gallé||Recruiting|
|Contact: François SIRVEAUX email@example.com|
|Principal Investigator: François SIRVEAUX|
|Nantes University Hospital||Recruiting|
|Nantes, France, 44000|
|Contact: François Gouin, PhD firstname.lastname@example.org|
|Contact: Juliane Berchoud email@example.com|
|Paris Hospital Cochin||Recruiting|
|Contact: Philippe ANRACT firstname.lastname@example.org|
|Principal Investigator: Philippe ANRACT|
|Paris Hospital Kremlin-Bicêtre||Recruiting|
|Contact: Gilles MISSENARD email@example.com|
|Principal Investigator: Gilles MISSENARD|
|Principal Investigator:||François Gouin, Professor||Nantes University Hospital|