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
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
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma, Bone Tumor
Keywords: Pelvis
Surgical resection
Patient specific instrument
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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):

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

Primary outcomes:
measure: ICER between the innovation treatment group and the reference treatment group.
timeFrame: 3 years
Secondary outcomes:
measure: R0, R1 and R2 margin rates
timeFrame: Within 3 years after surgery
measure: Rate and nature of adverse events related to surgery for each treatment group
timeFrame: Per-operatively and within 3 years after surgery
measure: Quality Of Life (QOL) of patients treated by PSI (prospective group)
timeFrame: 0, 6, 12, 18, 24, 30 and 36 months
measure: 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)
timeFrame: 3 years
measure: MSTS score
timeFrame: 12 and 36 months
measure: TESS Score
timeFrame: 12 and 36 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital
city: Lyon
country: France
facility: Lyon Centre Léon Bérard
city: Lyon
country: France
facility: Lyon CRCM Les Massues
city: Marseille
country: France
facility: Marseille University Hospital
city: Nancy
country: France
facility: Nancy Centre Chirurgical Emile Gallé
city: Nantes
country: France
facility: Nantes University Hospital
city: Paris
country: France
facility: Paris Hospital Cochin
city: Paris
country: France
facility: Paris Hospital Kremlin-Bicêtre
Study officials:
affiliation: Nantes University Hospital
name: François Gouin, Professor
role: PRINCIPAL_INVESTIGATOR
References: