Osteoarthritis Clinical Trial
Official title:
Medical Imaging of the Musculoskeletal System Before and After Surgery for the Generation of Customized Biomechanical Models
The objective of this study is to design a library of biomechanical musculoskeletal models of patients before and after surgery. These models will be evaluated to analyze the support they can provide for virtual surgical planning in orthopedics.
While there are multiple surgical options for the treatment of a specific orthopaedic
pathology, the patient is most often operated on according to the preferred method used
within a team and not necessarily according to the method that would optimize the functional
result. In addition, the variability of morphologies means that some patients, due to their
anatomical characteristics, cannot benefit from an intervention that is necessary
(incorrectly sized implant, unsuitable equipment). As the orthopaedic surgical procedure is
definitive, the investigators believe that it may be useful to perform surgical simulations
on a digital clone before performing on the real patient. This would be relevant for the
patient, the caregiver, but also the community, as many surgical reopenings or treatment
failures can be attributed to the difficulty of properly planning surgery for a functional
objective in the long term.
This is a Retrospective study based on patient's record and medical imaging files.
50 patients For 3D medical imaging, the data will be obtained from the examinations performed
by the patient before and after his surgery, they will be anonymized. The investigators will
use the so-called "DICOM" sequences allowing the reconstruction of 3D models The personal
data collected will be taken from the Surgical Report and the pre-surgical check-up (age,
sex, height, weight) The patient identifier will be assigned for each subject with the centre
number, initials (Surname / First name of the patient) and its inclusion number per centre.
Personal data will be obtained from the department's computerized or paper patient file
Medical imaging data will be anonymized by the medical imaging department staff who will be
assigned the patient identifier.
The database will be centralized and hosted on a laboratory computer on an encrypted and
password-protected session.
The usable patient records will be recruited according to the database of surgical procedures
performed in the various departments. If the file meets the inclusion and non-inclusion
criteria, patients will then be contacted (telephone) to discuss their participation in the
study, and verbally obtain their non-opposition.
Patients will be informed in a complete and fair manner, in understandable terms, of the
objectives of the study, their right to refuse to participate in the study or the possibility
of withdrawing at any time. All this information will be included on an information form
given to the patient by email or post.
Once the authorization has been obtained, the data will be anonymized and downloaded to an
encrypted hard disk for processing for model reconstruction.
Clinical data will be retrieved from the operative report and the pre-surgical file and then
integrated into the database.
The models resulting from this procedure will bear the name of the surgical procedure
associated with a patient identification number.
Morphological comparison of individual bone structures and the outer envelope including
internal soft tissues (measurement of distances and volumes) Comparison of radiological
parameters used in routine pre-surgery routine (measurement of angles, segment lengths,
tissue thickness) Between February 2019 and June 2021, the three surgical teams will search
for patients who have benefited from the surgeries and who meet the inclusion criteria.
The distribution will be as follows:
Grenoble University Hospital (12 cases):
- 5 patients Knee
- 5 patients Rachis
- 2 patients Hip
Raymond Poincaré University Hospital (19 cases):
2 patients for tendon transfer procedures
- 1 patient for muscle stretching
- 2 patients for lower limb amputations
- 5 patients Rachis
- 6 patients Foot / Ankle
- 1 patient Shoulder
- 2 patients Elbow / Hand
Groupe Hospitalier Croix saint Simon (19 cases):
- 3 patients Knee
- 2 Patients Hip
- 9 patients Foot / Ankle
- 2 patients Shoulder
- 3 patients Elbow / Hand
From April 2019, the models will begin to be developed by the TIMC IMAG laboratory team.
Once the biomechanical models are developed, the investigators will virtually apply the
surgery performed on the pre-surgical models. Then the investigators will compare the virtual
post surgery models with the post surgical models. A description of the limitations of the
virtual procedures will be established in order to analyze the scientific locks to be removed
and move towards biomechanical simulation-based surgical planning.
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