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Joint DiseaseORTHOSIMV1NCT03835000

Customized Biomechanical Models of the Musculoskeletal System Before and After Surgery

An observational study of Joint Disease and Joint Instability, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Joint Disease, Joint Instability, Osteoarthritis
What is being tested?
Orthopedic surgery
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteFrance
Study dates
19 Jan 2019to 1 Oct 2021
Phase
Observational
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 20 to 65 years
  • All sexes
  • Adult, Older adult

Study population: Patients aged 20 to 65 years who require orthopaedic surgery as described in the literature and for which 3D medical imaging will be performed before and after the surgical procedure.

Who may be able to join

  • Men or women aged 20 to 65 years
  • Patients who have had orthopaedic surgery
  • Presence in the file of a preoperative CT scan and/or magnetic resonance imaging (MRI)
  • Presence in the file of a CT scan and/or MRI postoperatively at a distance from the operation (at least 4 weeks)
  • Presence in the file of an operating report describing the procedure in detail with access routes, operating times, type of equipment and possible complications.
  • Patient who has authorized the anonymous use of data from his pre and post surgical examinations
Show all 15Show fewer
  • Patient who is a member of a social security organisation
  • Criteria for non-inclusion:
  • Patient who has expressed his refusal to use his medical data
  • Minor, patient under guardianship, inability to receive information and express consent
  • Pregnant women
  • Non-affiliation to a social security scheme (beneficiary or beneficiary)
  • Examinations of images that do not allow 3D reconstruction of structures (poor resolution or type of sequence)
  • Incomplete operating report not allowing the understanding of the steps of the surgery.
  • Surgical report describing surgery that does not represent the usual procedures performed.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Laboratoire CNRS TIMC IMAG

    La Tronche, Grenoble Alpes University - CNRS UMR, 38706

    Perrier Antoine, + 33 (0)144741019, perrier.antoine@gmail.com

    Recruiting

Other trials in France

About this study

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.

Read the detailed description

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.

Being tested
Orthopedic surgery
Keywords
virtual patient, joint modeling, biomechanical simulation, surgery mechanical results
Medical subject headings
Joint Diseases, Joint Instability, Osteoarthritis, Bone Malalignment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orthopedic surgeryProcedure or surgery

    Also called Medical imaging

    before and after surgery, patient will need medical imaging to asses their conditions

Study groups in NCT03835000
Study groupRoleWhat they receive
Pre operative patientPatients who will require orthopedic surgery for corrective, replacement or repair
Receives: Procedure: Orthopedic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bones volume assessment

    Comparison of volume of bone pieces in mm3

    Measured: 20 days

  2. Soft tissue volume assessment

    Volume comparison of soft tissue envelope in mm3

    Measured: 20 days

  3. Relative positions of bones

    Comparison of the relative positions of bones relative to each other in degrees

    Measured: 10 days

Secondary outcomes (1)
  1. Biomechanical response

    the convergence of the numerical simulation performed from the reconstructed model.

    measurement of the Stress in Nm-2 and the strains (Strain has no units because it is a ratio of lengths)

    Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2019
  2. Study start19 Jan 2019
  3. Primary completion1 Mar 2021 (estimated)
  4. Study completion1 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03835000
Sponsor's protocol ID
CNIL 2168319 v 0
Acronym
ORTHOSIMV1
Status last verified
Oct 2019
First submitted
5 Nov 2018
Last updated
18 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Joint Disease and Joint Instability, run by Centre d'Investigation Clinique et Technologique 805 at 1 site 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 15 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Perrier Antoine, Dr (+33 (1)44 74 10 19, perrier.antoine@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bones volume assessment (time frame: 20 days). The study lists 3 primary outcomes in all. 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 18 Nov 2019.

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