Clinical Trial: 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 Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: ICER between the innovation treatment group and the reference treatment group. [ Time Frame: 3 years ]

Incremental Cost-Effectiveness Ratio (ICER) as assessed from the healthcare system perspective: Cost/Local prevented recurrence at 3 years postoperatively


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • R0, R1 and R2 margin rates [ Time Frame: Within 3 years after surgery ]
    R0, R1 and R2 margin rates as observed by histological exam for each surgical treatment, for each treatment group.
  • 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) [ Time Frame: 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) [ Time Frame: 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.
  • MSTS score [ Time Frame: 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 [ Time Frame: 12 and 36 months ]
    Toronto Extremity Salvage Score (TESS) which evaluates 30 items about the global function and patient's activity level.


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: August 24, 2015
Date Started: December 2015
Date Completion: December 2021
Last Updated: August 26, 2016
Last Verified: August 2016