Sarcoma, Bone TumorMARGICNCT02544711
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
A study testing Patient specific instrument and Conventional surgical treatment in people with Sarcoma, Bone Tumor, run by Nantes University Hospital at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Bone Tumor
- What is being tested?
- Patient specific instrument and Conventional surgical treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 8 sitesFrance
- Study dates
- Dec 2015to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- Retrospective group (reference)
- Patient not fulfilling the protocol matching criteria
- Refusal to participate
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Lille University Hospital
Lille
Lyon Centre Léon Bérard
Lyon
Lyon CRCM Les Massues
Lyon
Marseille University Hospital
Marseille
Nancy Centre Chirurgical Emile Gallé
Nancy
Nantes University Hospital
Nantes, 44000
Paris Hospital Cochin
Paris
Paris Hospital Kremlin-Bicêtre
Paris
About this study
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).
Read more
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.
- Conditions
- Sarcoma, Bone Tumor
- Being tested
- Patient specific instrument, Conventional surgical treatment
- Keywords
- Pelvis, Surgical resection, Patient specific instrument
- Medical subject headings
- Sarcoma, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient specific instrumentDevice
Also called PSI-T, 3D-Side
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.
Conventional surgical treatmentProcedure or surgery
The conventional treatment is planned on two-dimensional images (CT and MRI).
| Study group | Role | What they receive |
|---|---|---|
| Prospective group :Innovation | Experimental | Surgical treatment using a patient specific instrument (PSI) Receives: Device: Patient specific instrument |
| Retrospective group: Reference | Other | Conventional surgical treatment without PSI, using 2D imaging planification Receives: Procedure: Conventional surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICER between the innovation treatment group and the reference treatment group.
Incremental Cost-Effectiveness Ratio (ICER) as assessed from the healthcare system perspective: Cost/Local prevented recurrence at 3 years postoperatively
Measured: 3 years
Secondary outcomes (6)
R0, R1 and R2 margin rates
R0, R1 and R2 margin rates as observed by histological exam for each surgical treatment, for each treatment group.
Measured: Within 3 years after surgery
Rate and nature of adverse events related to surgery for each treatment group
Measured: Per-operatively and within 3 years after surgery
Quality Of Life (QOL) of patients treated by PSI (prospective group)
Euroqol questionnaire score
Measured: 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)
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.
Measured: 3 years
MSTS score
Musculoskeletal Tumor Society (MSTS) Score which evaluates 6 items: pain, function, emotional acceptance, walking capacity, technical walking aids, gait.
Measured: 12 and 36 months
TESS Score
Toronto Extremity Salvage Score (TESS) which evaluates 30 items about the global function and patient's activity level.
Measured: 12 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, Bone TumorStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Gouin, Professor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544711
- Sponsor's protocol ID
- RC15_0097
- Acronym
- MARGIC
- Status last verified
- Jul 2021
- First submitted
- 24 Aug 2015
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02544711
- Acronym / sponsor ID
- MARGIC / RC15_0097
- Conditions
- Sarcoma, Bone Tumor
- Keywords
- Pelvis, Surgical resection, Patient specific instrument
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective group :Innovation | Experimental | Device: Patient specific instrumentSurgical treatment using a patient specific instrument (PSI) |
| Retrospective group: Reference | Other | Procedure: Conventional surgical treatmentConventional surgical treatment without PSI, using 2D imaging planification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (9 listed)
- Prospective group (innovation)
- Patient suffering from a local recurrence or a metastasis at recruitment time
- Absence of informed consent
- Pregnancy or breastfeeding
- Minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient specific instrumentAlso: PSI-T, 3D-SideThe 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. | Device | Prospective group :Innovation |
| Conventional surgical treatmentThe conventional treatment is planned on two-dimensional images (CT and MRI). | Procedure or surgery | Retrospective group: Reference |
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
6 secondary outcomes
R0, R1 and R2 margin rates
Time frame: Within 3 years after surgery
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
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
MSTS score
Time frame: 12 and 36 months
TESS Score
Time frame: 12 and 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Gouin, Professor principal investigator
Nantes University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient specific instrument and Conventional surgical treatment in people with Sarcoma, Bone Tumor, run by Nantes University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICER between the innovation treatment group and the reference treatment group. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.