- Who can use this service?
- Orthopaedic surgeons (eventually, neurosurgeons as well).
- Implant designers.
- Academic users (researchers, university personnel and students).
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- What is the advantage for the patient?
This simulation service helps the surgeon in the planning phase of a surgery
dealing with implants in the lumbar spine. Since many times complications
due to a mechanical failure are the cause of reoperations, orthoSIM
should help prevent these situations by helping the surgeon choose the right
implant and the right procedure for a particular patient.
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- What are the advantages for the surgeon?
The simulation service is an objective pre-operational planning tool that
helps reduce the number of failures and consequently the associated risks
and expenses.
It can help reduce the failures risk due to the spine implants, since the
load that the implant will have to support once implanted in a particular
patient will have been studied previously.
It can help the surgeon gain access to an easy-to-use on-line tool that
manages historic simulation files, clinical showcases, interesting articles,
rigorous discussions with the scientific community, etc.
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- What are the advantages for the implant designer?
This tool is also designed for implant manufacturers since it holds one
of the most reliable, precise and validated biomechanical models of the
lower spine. The main advantages of simulation for implant designers are:
- To reduce the time in developing new spine implants (reduction estimated
at 30% of the time to develop a comparable implant).
- To obtain more reliable spine implants, which will require less laboratory
tests (estimated at 50%) to check their correct mechanical behaviour.
- To reduce manufacturing costs, developing more competitive products
(reduction estimated at 25% of the price of comparable products).
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- How can you use this service?
Any surgeon or implant designer that fills in our new user’s registration
form can use this service during one month for free. It may take about one
working day until our team confirms your registration data and sends you
an email with your entry code and password.
This password will grant you unlimited access to our clinical simulation
database, user forum, document repository and manufacturer catalogues during
one month.
If you are a clinical user, you will also obtain 100 credits
for evaluating our surgical planning simulation services. With 100 credits
you can launch, for instance, 10 single clinical simulation studies, using
distinct implant systems from recognized national and international European implant manufacturers.
If you are an implant designer, you will obtain 10 credits
for evaluating our implant design simulation services with 10 different design
configurations which you can define and simulate.
If you are an academic user, you will obtain 50 credits for evaluating our surgical planning simulation services and 5 credits for evaluating our implant design simulation services, which will grant you 5 clinical studies and 5 implant design studies.
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- Do I have to pay for this service?
You can test our service during an evaluation period of one month for free.
You just have to fill in our new user’s registration form. The only
requisite is that you have one of the following professional profiles:
- Orthopaedic surgeon, neuro-surgeon or health centre manager;
- Implant designer/ engineer or company manager;
- Medicine student or faculty staff;
- Biomedical/ biomechanical engineering student or faculty staff.
Depending on your user profile, you will also obtain an amount of credits
for testing our simulation services. If you want to launch more simulations,
you can also buy credits using our on-line payment gateway.
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- How can I obtain simulation credits?
There are several ways of obtaining simulation credits, depending upon
your job and the organization where you are employed.
If you are an orthopaedic surgeon or neuro-surgeon, the health organisation
where you are working can contact the orthoSIM team to
buy credits for sponsoring your surgical planning.
If you are an implant designer in a company, ask your
marketing department to get in touch with the orthoSIM
team. After modelling of your company’s products, you can launch design
simulations from this portal and take advantage of the functional prognoses
of one of the most precise finite element models of the lumbar spine.
If you are a private user (clinician, student, health manager,
etc), you can also buy simulation credits using our e-commerce
payment gateway. These credits will give you access to any implant system
offered for simulation.
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- What are the possible types of simulation credits?
Simulation credits are virtual credits (equivalent to money) that allow
the user to carry out simulations in the portal. There are two types of
credits:
- Sponsor credits are restricted credits that are assigned
by implant manufacturers to some users (e.g. their employees), in order to carry out simulations
with the manufacturer's products exclussively.
- Private credits are unrestricted credits that can be
bought by any user or organisation, in order to carry out simulations
with any available product, irrespective of the implant manufacturer.
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- Are the responses given by the simulation engine reliable?
Yes, the responses given are based on a computer simulation of a finite
element model that has been developed by leading research centres in orthopaedics
and biomechanics after decades of rigorous work.
These results have been validated in different ways. The implant model
has been tested with mechanical tests, whereas the human spine model has
been tested with cadaveric specimens, as well as with functional in-vivo
tests.
Overall results of the simulation are being validated with real retrospective
cases (positive and negative results), as well. Moreover, the simulation
engine is continuously peer reviewed by an independent group of experts
that integrate our Scientific Committee.
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- Who is responsible for the validation of the model?
The owners of the model are responsible for the initial validation of the
model and the continuous monitoring of its validity.
An independent group of experts that integrate the orthoSIM’s
Scientific Committee supervises the clinical results issued by the model
owners.
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- How much time does it take to obtain simulation results?
The time of each simulation cycle depends on the model chosen, the number of simulations waiting, and the time it needs to reach convergence, that means, the time to reach a stable result.
Presently, our lumbar spine model takes an average of 20 minutes to finish each simulation cycle. If no convergence is reached after 30 minutes, the simulation is aborted. In any case, the user is immediately alerted by an email.
You must remember, that when you choose a comparative study with e.g. two
different surgical techniques, the simulation engine will need twice the
time as for a single analysis.
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- What happens if my simulation request does not not have appropriate input data?
Simulations requests with logical input parameters generally converge in valid results, whereas requests with inappropriate input data can lead to calculation failure.
The user-friendly interface limits the data entry from inconsistent configurations to a reasonable extent, but cannot avoid requests that are not properly defined, or that are not compatible with the usual praxis.
When a simulation request does not converge, the system will abort the simulation after a time threshold (about 30 minutes) and will notify the user. In those cases, no credits will be charged to the user.
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- Can I compare different surgical configurations with
the same implant system?
Yes, you can select a comparative study with two different surgical configurations
and the input simulation process will loop twice, until you define all the
input specifications.
A comparative study of two implant configurations will cost twice the price of a single analysis.
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- Can I compare different implant systems with the same
surgical configuration?
Within one comparative study, you can only compare different implant systems
of one and the same manufacturer.
No comparative studies are allowed with distinct manufacturers. The reason
is due to potential discrepancies of implant modelling that could lead to
a false selection of the best implants.
If you are being sponsored by a manufacturer, you will have access to this
manufacturer’s catalogue only. However, if you buy private simulation
credits, you may carry different studies with implant systems from different
providers.
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- What must a manufacturer do to be included in the simulation’s
implant catalogue?
He must get in touch with the orthoSIM team and join our
“Implant Integration Programme” (IIP). The IIP consists of modelisation
of the implant systems and eventual adjustments of the finite element model,
in order to cope with the particularities of the new mechanical solution.
Once the products are modelled and incorporated into the simulation portal’s
catalogue, the users will have the possibility of performing simulations,
whereas the manufacturer will have the option to visualize his new products
in the portal and to offer sponsor credits to selected persons.
This process may require several weeks, depending upon the complexity of the modelisation process.
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- How can a manufacturer promote the use of this tool
among his best clients?
A manufacturer with modelled implants has a special portal utility that
enables him to “pump” sponsor credits to any given user of the
system.
This user will receive a notification from the portal, and will enjoy these
extra credits for launching new simulations with the manufacturer’s
catalogue.
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- How can a manufacturer control the products offered
for simulation?
Each manufacturer has complete control both over the display of his products
on the portal’s implant catalogue and the possibility to make simulations
with them.
The manufacturer may decide to blind a specific product from the portal’s catalogue, but to offer it for sponsored simulation only to his best clients. Or he may decide to display a specific product, but prevent simulations with it. Finally, he may also promote a specific product by offering it to any user with private simulation credits, including just registered members in the evaluation period.
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- Are there any other models avalaible for simulation?
Yes, the orthoSIM team is working in some research and
development projects with several prestigious labs, in order to integrate
further models into the SSP platform.
You can find other models available in the Service Portal of orthoSIM,
under the heading “Model catalogue”.
You can also learn more details from our 'Model Integration Programme'
(MIP).
But not all models are valid for us; only those that have the guarantee
from a serious and renowned research centre owning a model for research
purposes, whose validity and reliability and has been demonstrated, preferably
in peer-review publications.
These labs can become certified by orthoSIM to carry out
a technical maintenance and a continuous validation of their model results,
joining forces and benefits with our organisation.
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Below a
list of the most frequently asked questions from our users, customers and prescribers:
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