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Completed

NCT Number: 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

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.

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Key information

Conditions

Sarcoma, Bone Tumor Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lille University Hospital, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):

  • 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).

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

Treatment and study plan

Patient specific instrument

Device

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.

Other names: PSI-T, 3D-Side

Conventional surgical treatment

Procedure

The conventional treatment is planned on two-dimensional images (CT and MRI).

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Rate and nature of adverse events related to surgery for each treatment group

    Time frame: Per-operatively and within 3 years after surgery

  3. 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

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: MARGIC

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2015
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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