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

Not Applicable

Completed

• Conditions: Sarcoma, Bone Tumor
• Interventions: Device: Patient specific instrument; Procedure: Conventional surgical treatment

• Registration Number: NCT02544711
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-09
• Study Start: 2015-12
• Primary Completion: 2021-05
• Study Completion: 2021-05
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective group :Innovation	Patient specific instrument	Surgical treatment using a patient specific instrument (PSI)
Retrospective group: Reference	Conventional surgical treatment	Conventional surgical treatment without PSI, using 2D imaging planification

Primary Outcome Measures

Name	Time	Method
ICER between the innovation treatment group and the reference treatment group.	3 years	Incremental Cost-Effectiveness Ratio (ICER) as assessed from the healthcare system perspective: Cost/Local prevented recurrence at 3 years postoperatively

Secondary Outcome Measures

Name	Time	Method
R0, R1 and R2 margin rates	Within 3 years after surgery	R0, R1 and R2 margin rates as observed by histological exam for each surgical treatment, for each treatment group.
Quality Of Life (QOL) of patients treated by PSI (prospective group)	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)	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.
Rate and nature of adverse events related to surgery for each treatment group	Per-operatively and within 3 years after surgery
MSTS score	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	12 and 36 months	Toronto Extremity Salvage Score (TESS) which evaluates 30 items about the global function and patient's activity level.

Trial Locations

Locations (8)

Paris Hospital Cochin; 🇫🇷 Paris, France

Lyon Centre Léon Bérard; 🇫🇷 Lyon, France

Paris Hospital Kremlin-Bicêtre; 🇫🇷 Paris, France

Lyon CRCM Les Massues; 🇫🇷 Lyon, France

Nancy Centre Chirurgical Emile Gallé; 🇫🇷 Nancy, France

Lille University Hospital; 🇫🇷 Lille, France

Marseille University Hospital; 🇫🇷 Marseille, France

Nantes University Hospital; 🇫🇷 Nantes, France