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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 9
- 主要终点
- ICER between the innovation treatment group and the reference treatment group.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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):
- •Tumor location (Enneking zones 1, 2, 1-2, 2-3, 1-2-3, 1-2-4, 1-2-3-4, 1-4, sacrum)
- •Tumor type (chondrosarcoma, osteosarcoma, Ewing, chordoma, other tumor type)
- •Surgery center
- •Tumor size (as close as possible between both patients)
- •Response to chemotherapy (good, bad, not applicable).
排除标准
- •Prospective group (innovation)
- •Patient suffering from a local recurrence or a metastasis at recruitment time
- •Absence of informed consent
- •Pregnancy or breastfeeding
- •Adults under guardianship or trusteeship
- •Retrospective group (reference)
- •Patient not fulfilling the protocol matching criteria
- •Refusal to participate
结局指标
主要结局
ICER between the innovation treatment group and the reference treatment group.
时间窗: 3 years
Incremental Cost-Effectiveness Ratio (ICER) as assessed from the healthcare system perspective: Cost/Local prevented recurrence at 3 years postoperatively
次要结局
- R0, R1 and R2 margin rates(Within 3 years after surgery)
- Quality Of Life (QOL) of patients treated by PSI (prospective group)(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)(3 years)
- 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)
- TESS Score(12 and 36 months)