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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective group :Innovation | Experimental | Surgical treatment using a patient specific instrument (PSI) |
|
| Retrospective group: Reference | Other | Conventional surgical treatment without PSI, using 2D imaging planification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 3 years after surgery |
| Rate and nature of adverse events related to surgery for each treatment group |
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Screening Critieria:
Retrospective group (reference)
Inclusion Criteria:
Prospective group (innovation)
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):
Exclusion Criteria:
Prospective group (innovation)
Retrospective group (reference)
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| Name | Affiliation | Role |
|---|---|---|
| François Gouin, Professor | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lille University Hospital | Lille | France | ||||
| Lyon Centre Léon Bérard |
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| Conventional surgical treatment | Procedure | The conventional treatment is planned on two-dimensional images (CT and MRI). |
|
| Per-operatively and within 3 years after surgery |
| Quality Of Life (QOL) of patients treated by PSI (prospective group) | 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) | 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 | 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 | Toronto Extremity Salvage Score (TESS) which evaluates 30 items about the global function and patient's activity level. | 12 and 36 months |
| Lyon |
| France |
| Lyon CRCM Les Massues | Lyon | France |
| Marseille University Hospital | Marseille | France |
| Nancy Centre Chirurgical Emile Gallé | Nancy | France |
| Nantes University Hospital | Nantes | 44000 | France |
| Paris Hospital Cochin | Paris | France |
| Paris Hospital Kremlin-BicĂȘtre | Paris | France |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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