An interventional study of Patient specific instrument and Conventional surgical treatment in Sarcoma, Bone Tumor, sponsored by Nantes University Hospital. Completed at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
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.
322 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.
This study's enrollment of 88 is above the median of 50 across 218 interventional studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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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)
Surgical treatment using a patient specific instrument (PSI)
Device: Patient specific instrument
Conventional surgical treatment without PSI, using 2D imaging planification
Procedure: Conventional surgical treatment
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.
Also known as: PSI-T, 3D-Side
The conventional treatment is planned on two-dimensional images (CT and MRI).
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
Time frame: 3 years
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.
Time frame: 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
Quality Of Life (QOL) of patients treated by PSI (prospective group)
Euroqol questionnaire score
Time frame: 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.
Time frame: 3 years
MSTS score
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
TESS Score
Toronto Extremity Salvage Score (TESS) which evaluates 30 items about the global function and patient's activity level.
Time frame: 12 and 36 months
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital