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.
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
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- 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
- Recruiting
Laboratoire CNRS TIMC IMAG
La Tronche, Grenoble Alpes University - CNRS UMR, 38706
Perrier Antoine, + 33 (0)144741019, perrier.antoine@gmail.com
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.
- Conditions
- Joint Disease, Joint Instability, Osteoarthritis, Bone Malalignment
- 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 group | Role | What they receive |
|---|---|---|
| Pre operative patient | Patients 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.
Bones volume assessment
Comparison of volume of bone pieces in mm3
Measured: 20 days
Soft tissue volume assessment
Volume comparison of soft tissue envelope in mm3
Measured: 20 days
Relative positions of bones
Comparison of the relative positions of bones relative to each other in degrees
Measured: 10 days
Secondary outcomes (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.
- First posted8 Feb 2019
- Study start19 Jan 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale, Fondation Garches, TIMC-IMAG
- Responsible party
- Sponsor
- Investigators
- Perrier Antoine, Dr, Principal investigator, CIC 1429
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Imaging of the Musculoskeletal System Before and After Surgery for the Generation of Customized Biomechanical Models
- ClinicalTrials.gov ID
- NCT03835000
- Acronym / sponsor ID
- ORTHOSIMV1 / CNIL 2168319 v 0
- Conditions
- Joint Disease, Joint Instability, Osteoarthritis, Bone Malalignment
- Keywords
- virtual patient, joint modeling, biomechanical simulation, surgery mechanical results
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale, Fondation Garches, TIMC-IMAG
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 8 Feb 2019 (actual)
- 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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre operative patient | – | Procedure: Orthopedic surgeryPatients who will require orthopedic surgery for corrective, replacement or repair |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Orthopedic surgeryAlso: Medical imagingbefore and after surgery, patient will need medical imaging to asses their conditions | Procedure or surgery | Pre operative patient |
Primary outcome
Bones volume assessment
Time frame: 20 days
Comparison of volume of bone pieces in mm3
Soft tissue volume assessment
Time frame: 20 days
Volume comparison of soft tissue envelope in mm3
Relative positions of bones
Time frame: 10 days
Comparison of the relative positions of bones relative to each other in degrees
1 secondary outcome
Biomechanical response
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Perrier Antoine, Dr principal investigator
CIC 1429
1 site in 1 country: see every site and its status.
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.