Orthopedic DisorderOrthosimProNCT04668430
Evaluation of Personalized Biomechanical Models of the Musculoskeletal System Before and After Orthopedic Surgeries
A study testing imaging and motion analysis in people with Orthopedic Disorder, run by Centre d'Investigation Clinique et Technologique 805.
Trial summary
Advances in biomechanical modeling of musculoskeletal systems make it possible to consider the use of a digital clone of a patient to test surgical procedure before carrying it out on the patient himself. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- imaging and motion analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2020to 15 Oct 2023
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- If women, menopausal or on contraception if of childbearing age
- Patients who will benefit from one of the orthopedic surgical procedures corresponding to the surgeries studied
- Patient who is a member of a social security organization
- Patient who has signed a written informed consent form
Who cannot join
- Patient refusal to participate in the study
- Minor,
- Patient under guardianship and / or curators,
- Patient unable to receive information and express consent
- Pregnant and/or breastfeeding women
- Contraindication to MRI (presence of ferromagnetic materials, neurosurgical clips, vascular, pacemaker).
- Non-affiliation to a social security scheme (beneficiary or entitled person)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Imaging for the Generation of Personalized Biomechanical Models of the Musculoskeletal System Before and After Surgery
Advances in biomechanical modeling of musculoskeletal systems make it possible to consider the use of a digital clone of a patient to test surgical procedure before carrying it out on the patient himself.
The study aims at evaluating the design and simulation procedure of anatomical and functional pre and post surgical patient-specific numerical models.
Read the detailed description
The general research framework is focused on predicting the functional outcome of orthopaedic surgery for a given patient.
Since surgery is an invasive and irreversible procedure, it may be useful to carry out surgical simulations on a digital clone before performing them on the real patient.
This simulation would therefore be a tool for optimized surgical planning, based on a realistic functional objective.
The investigators' work in the design and evaluation of biomechanical models is now applicable to orthopedic surgery.
So, it is necessary to verify that the digital procedures allowing the realization of virtual surgical gestures are comparable to the procedures actually applied to the patient.
Thus, a first retrospective study (Imaging for the generation of personalized biomechanical models of the musculoskeletal system before and after surgery - ORTHOSIM Retrospective) Clinical Trial N° NCT03835000, is in progress in order to validate the possibility of creating pre- and post-operative anatomical digital clones. The aim of this prospective study is to integrate the functional characteristics of the patient before and after surgery with the objective of dynamic validation of the biomechanical models created.
OrthosimPro is a bi-centric, longitudinal and prospective study.
10 patients needing orthopedic surgery will be enrolled after being informed about the study and potential risks. They will give written informed consent.
This study will not modify :
- the operative indication
- the surgical procedure
- the management before and after the surgery
Patients will have a pre and post operative assessment
- Anatomical by sectional imaging
- Functional by motion analysis
Thus, it allows creating 3 digital models for the same patient:
- Creation of Model 1: preoperative dynamic model obtained from the anatomical and functional preoperative assessment.
- Creation of Model 2: Model 1 to which the surgery is applied according to the criteria indicated by the surgeon.
- Creation of Model 3: a dynamic postoperative model independent of Models 1 and 2 obtained from the anatomical and functional postoperative assessment.
Validation of each model:
Each model will be compared with the patient data used to build the model, there is no comparison of patients regarding each other or models belonging to different patients. This study therefore aims to validate an individual's model on his or her own data.
- Comparison of model 1 (angle, forces, geometry) versus morphological and functional assessment before surgery
- Comparison of model 3 (angle, forces, geometry) versus morphological and functional assessment after surgery
Evaluation the surgery simulation procedure:
Comparison of model 2 (angle, forces, geometry) versus model 3
- Conditions
- Orthopedic Disorder
- Being tested
- imaging and motion analysis
- Keywords
- computer simulation, orthopedic surgical procedures, Multimodal Imaging, gait analysis
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaging and motion analysisOther
performing a set of imaging and motion analysis tests before and after orthopedic surgery without modifying the operative indication or the pre- and post-operative management.
| Study group | Role | What they receive |
|---|---|---|
| patients | Other | Patients for whom orthopedic surgery is indicated and planned among :
* Tibial valgus osteotomy
* Supra-malleolar osteotomy
* Hallux osteotomy for hallux valgus
* Total knee arthroplasty
* Total ankle arthroplasty
* Ankle arthrodesis
* Hallux arthrodesis
* Rear foot torque arthrodesis
* Inverted shoulder prosthesis
* Anterior lumbar interbody arthrodesis Receives: Other: imaging and motion analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of simulated models regarding relative position of bones in static condition
comparison between real data (from imaging) vs simulated data regarding relative position of bones defining a joint:
angles between mechanical bone axis in degree
in two situations:
- angles measured on pre operative imaging versus angles obtained on model 1
- angles measured on post operative imaging versus angles obtained on model 3
Measured: 18 months
Evaluation of simulated models regarding relative position of bones in dynamic condition: range of motion (ROM)
comparison between real data (from motion analysis) vs simulated data regarding relative position of bones defining a joint:
total joint range of motion (ROM) projected in anatomical planes : degree of freedom of the joint (flexion, extension, abduction, adduction, medial and lateral rotation) (Kinematic parameters)
in two situations:
- ROM measured on pre operative motion analysis versus ROM obtained on model 1
- ROM measured on post operative motion analysis versus ROM obtained on model 3
Measured: 18 months
Evaluation of simulated models regarding forces
comparison between real data (from motion analysis) vs simulated data regarding kinetic parameters as forces (ground reaction forces)
in Newton (N)
in two situations:
- forces measured on pre operative motion analysis versus forces obtained on model 1
- forces measured on post operative motion analysis versus forces obtained on model 3
Measured: 18 months
Evaluation of simulated models regarding moment
comparison between real data (from motion analysis) vs simulated data regarding kinetic parameters as joint moment
in Newton-metre (N.m)
in two situations:
- moment calculated on pre operative motion analysis versus moment obtained on model 1
- moment calculated on post operative motion analysis versus moment obtained on model 3
Measured: 18 months
Evaluation of simulated models regarding pressure
comparison between real data (from motion analysis) vs simulated data regarding kinetic parameters as pressure (baropodometric analysis)
in Newton per square centimeter (N/cm2)
in two situations:
- pressure measured on pre operative motion analysis versus pressure obtained on model 1
- pressure measured on post operative motion analysis versus pressure obtained on model 3
Measured: 18 months
comparison of post surgery changes in real and simulated results regarding bone dimension
comparison between real bone dimension's changes (from imaging) vs bone dimension's changes on simulated data
difference calculated in mm
in one situation:
- bone dimension's difference calculated on CT scan (difference between pre and post operative bone dimensions) versus bone dimension's difference calculated on models (difference between bone dimensions obtained on model 1 and model 3)
Measured: 18 months
comparison of post surgery changes in real and simulated results regarding bone torsion
comparison between real bone torsion's changes (from imaging) vs bone torsion's changes on simulated data,
difference calculated in degree
in one situation:
- bone torsion's difference calculated on CT scan (difference between pre and post operative bone torsions) versus bone torsion's difference calculated on models (difference between bone torsions obtained on model 1 and model 3)
Measured: 18 months
comparison of post surgery changes in real and simulated results regarding bone axis
comparison between real bone axis changes (from imaging) vs bone axis changes on simulated data : anatomical bone axis (corresponding mainly to the diaphyseal axis))
difference calculated in degree
in one situation:
- bone axis difference calculated on imaging (difference between pre and post operative bone torsion) versus bone torsion's difference calculated on models (difference between bone torsions obtained on model 1 and model 3)
Measured: 18 months
comparison of post surgery changes in real and simulated results regarding bone volume
comparison between real bone volume changes (from imaging) vs bone volume changes on simulated data
difference calculated in mm3
in one situation:
- bone volume difference calculated on CT scan (difference between pre and post operative bone volumes) versus bone volume difference calculated on models (difference between bone volumes obtained on model 1 and model 3)
Measured: 18 months
comparison of post surgery changes in real and simulated results regarding relative position of bones in static condition
comparison between real mechanical angle changes (from imaging) vs mechanical angle changes on simulated data
difference between angles (obtained from mechanical bone axis) calculated in degree
in one situation:
- mechanical angle difference calculated on imaging (difference between pre and post operative mechanical angles) versus mechanical angle difference calculated on models (difference between mechanical angles obtained on model 1 and model 3)
Measured: 18 months
comparison of post surgery changes in real and simulated results regarding ROM's changes
comparison between real ROM'S changes (from motion analysis) vs ROM's changes on simulated data
joint range of motion's difference calculated in degree
in one situation:
- ROM's difference calculated on motion analysis (difference between pre and post operative ROM) versus ROM's difference calculated on models (difference between ROM obtained on model 1 and model 3)
Measured: 18 months
comparison of post surgery changes in real and simulated results regarding moment changes
comparison between real moment changes (from motion analysis) vs moment changes on simulated data
moment difference calculated in N.m
in one situation:
- moment difference calculated on motion analysis (difference between pre and post operative moments) versus moment difference calculated on models (difference between moments obtained on model 1 and model 3)
Measured: 18 months
comparison of post surgery changes in real and simulated results regarding pressure changes
comparison between real pressure changes (from motion analysis) vs pressure changes on simulated data
pressure difference calculated in N/cm2
in one situation:
- pressure difference calculated on motion analysis (difference between pre and post operative pressures) versus pressure difference calculated on models (difference between pressures obtained on model 1 and model 3)
Measured: 18 months
Secondary outcomes (12)
correlation of clinical scores and changes in function
changes in clinical scores (percentage) compared to the variation in the range of motion of joints studied
Measured: 18 months
Comparison of post surgery models between real and simulated surgery regarding bone dimension
comparison between bone dimension in simulated surgery (model 2) and bone dimension in real surgery model (model 3)
difference calculated in mm
Measured: 18 months
Comparison of post surgery models between real and simulated surgery regarding bone torsion
comparison between bone torsion in simulated surgery (model 2) and bone torsion in real surgery model (model 3)
difference calculated in degree
Measured: 18 months
Comparison of post surgery models between real and simulated surgery regarding bone axis
comparison between bone axis in simulated surgery (model 2) and bone axis in real surgery model (model 3) : anatomical bone axis (corresponding mainly to the diaphyseal axis))
difference calculated in degree
Measured: 18 months
Comparison of post surgery models between real and simulated surgery regarding bone volume
comparison between bone volume in simulated surgery (model 2) and bone volume in real surgery model (model 3)
difference calculated in mm3
Measured: 18 months
Comparison of post surgery models between real and simulated surgery regarding point-to-surface distance of bone
comparison of point-to-surface distance between two pairs of bones model 1/ model 2 and model 1/model 3
difference calculated in mm
Measured: 18 months
Comparison of post surgery models between real and simulated surgery regarding relative position of bones in static condition
comparison between mechanical angle in simulated surgery (model 2) and mechanical angle in real surgery model (model 3)
difference between angles (obtained from mechanical bone axis) calculated in degree
Measured: 18 months
Comparison of post surgery models between real and simulated surgery regarding ROM's changes
comparison between ROM in simulated surgery (model 2) and ROM in real surgery model (model 3)
joint range of motion's difference calculated in degree
Measured: 18 months
Comparison of post surgery models between real and simulated surgery regarding ground reaction forces changes
comparison between forces in simulated surgery (model 2) and forces in real surgery model (model 3)
ground reaction forces difference calculated in Newton
Measured: 18 months
Comparison of post surgery models between real and simulated surgery regarding moment changes
comparison between moment in simulated surgery (model 2) and moment in real surgery model (model 3)
moment difference calculated in N.m
Measured: 18 months
Comparison of post surgery models between real and simulated surgery regarding pressure changes
comparison between pressure in simulated surgery (model 2) and pressure in real surgery model (model 3)
pressure difference calculated in N/cm2
Measured: 18 months
comparison of simulated joint force changes between Pre and post surgery models
comparison between simulated joint forces (from model 1) vs simulated joint forces (from model 2 and 3)
joint normal contact forces difference calculated in Newton
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start15 Dec 2020 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Garches
- Responsible party
- Sponsor
- Investigators
- Antoine M PERRIER, PHD, Principal investigator, laboratoire TIMC CNRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668430
- Sponsor's protocol ID
- 2019-A02124-53
- Acronym
- OrthosimPro
- Status last verified
- Apr 2020
- First submitted
- 12 Nov 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging for the Generation of Personalized Biomechanical Models of the Musculoskeletal System Before and After Surgery
- ClinicalTrials.gov ID
- NCT04668430
- Acronym / sponsor ID
- OrthosimPro / 2019-A02124-53
- Conditions
- Orthopedic Disorder
- Keywords
- computer simulation, orthopedic surgical procedures, Multimodal Imaging, gait analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Fondation Garches
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 16 Dec 2020 (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.
Advances in biomechanical modeling of musculoskeletal systems make it possible to consider the use of a digital clone of a patient to test surgical procedure before carrying it out on the patient himself.
The study aims at evaluating the design and simulation procedure of anatomical and functional pre and post surgical patient-specific numerical models.
Detailed description
The general research framework is focused on predicting the functional outcome of orthopaedic surgery for a given patient.
Since surgery is an invasive and irreversible procedure, it may be useful to carry out surgical simulations on a digital clone before performing them on the real patient.
This simulation would therefore be a tool for optimized surgical planning, based on a realistic functional objective.
The investigators' work in the design and evaluation of biomechanical models is now applicable to orthopedic surgery.
So, it is necessary to verify that the digital procedures allowing the realization of virtual surgical gestures are comparable to the procedures actually applied to the patient.
Thus, a first retrospective study (Imaging for the generation of personalized biomechanical models of the musculoskeletal system before and after surgery - ORTHOSIM Retrospective) Clinical Trial N° NCT03835000, is in progress in order to validate the possibility of creating pre- and post-operative anatomical digital clones. The aim of this prospective study is to integrate the functional characteristics of the patient before and after surgery with the objective of dynamic validation of the biomechanical models created.
OrthosimPro is a bi-centric, longitudinal and prospective study.
10 patients needing orthopedic surgery will be enrolled after being informed about the study and potential risks. They will give written informed consent.
This study will not modify :
- the operative indication
- the surgical procedure
- the management before and after the surgery
Patients will have a pre and post operative assessment
- Anatomical by sectional imaging
- Functional by motion analysis
Thus, it allows creating 3 digital models for the same patient:
- Creation of Model 1: preoperative dynamic model obtained from the anatomical and functional preoperative assessment.
- Creation of Model 2: Model 1 to which the surgery is applied according to the criteria indicated by the surgeon.
- Creation of Model 3: a dynamic postoperative model independent of Models 1 and 2 obtained from the anatomical and functional postoperative assessment.
Validation of each model:
Each model will be compared with the patient data used to build the model, there is no comparison of patients regarding each other or models belonging to different patients. This study therefore aims to validate an individual's model on his or her own data.
- Comparison of model 1 (angle, forces, geometry) versus morphological and functional assessment before surgery
- Comparison of model 3 (angle, forces, geometry) versus morphological and functional assessment after surgery
Evaluation the surgery simulation procedure:
Comparison of model 2 (angle, forces, geometry) versus model 3
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Other | Other: imaging and motion analysisPatients for whom orthopedic surgery is indicated and planned among : * Tibial valgus osteotomy * Supra-malleolar osteotomy * Hallux osteotomy for hallux valgus * Total knee arthroplasty * Total ankle arthroplasty * Ankle arthrodesis * Hallux arthrodesis * Rear foot torque arthrodesis * Inverted shoulder prosthesis * Anterior lumbar interbody arthrodesis |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- If women, menopausal or on contraception if of childbearing age
- Patients who will benefit from one of the orthopedic surgical procedures corresponding to the surgeries studied
- Patient who is a member of a social security organization
- Patient who has signed a written informed consent form
Key exclusion criteria (7 listed)
- Patient refusal to participate in the study
- Minor,
- Patient under guardianship and / or curators,
- Patient unable to receive information and express consent
- Pregnant and/or breastfeeding women
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 |
|---|---|---|
| imaging and motion analysisperforming a set of imaging and motion analysis tests before and after orthopedic surgery without modifying the operative indication or the pre- and post-operative management. | Other | patients |
Primary outcome
Evaluation of simulated models regarding relative position of bones in static condition
Time frame: 18 months
comparison between real data (from imaging) vs simulated data regarding relative position of bones defining a joint: angles between mechanical bone axis in degree in two situations: * angles measured on pre operative imaging versus angles obtained on model 1 * angles measured on post operative imaging versus angles obtained on model 3
Evaluation of simulated models regarding relative position of bones in dynamic condition: range of motion (ROM)
Time frame: 18 months
comparison between real data (from motion analysis) vs simulated data regarding relative position of bones defining a joint: total joint range of motion (ROM) projected in anatomical planes : degree of freedom of the joint (flexion, extension, abduction, adduction, medial and lateral rotation) (Kinematic parameters) in two situations: * ROM measured on pre operative motion analysis versus ROM obtained on model 1 * ROM measured on post operative motion analysis versus ROM obtained on model 3
Evaluation of simulated models regarding forces
Time frame: 18 months
comparison between real data (from motion analysis) vs simulated data regarding kinetic parameters as forces (ground reaction forces) in Newton (N) in two situations: * forces measured on pre operative motion analysis versus forces obtained on model 1 * forces measured on post operative motion analysis versus forces obtained on model 3
Evaluation of simulated models regarding moment
Time frame: 18 months
comparison between real data (from motion analysis) vs simulated data regarding kinetic parameters as joint moment in Newton-metre (N.m) in two situations: * moment calculated on pre operative motion analysis versus moment obtained on model 1 * moment calculated on post operative motion analysis versus moment obtained on model 3
Evaluation of simulated models regarding pressure
Time frame: 18 months
comparison between real data (from motion analysis) vs simulated data regarding kinetic parameters as pressure (baropodometric analysis) in Newton per square centimeter (N/cm2) in two situations: * pressure measured on pre operative motion analysis versus pressure obtained on model 1 * pressure measured on post operative motion analysis versus pressure obtained on model 3
comparison of post surgery changes in real and simulated results regarding bone dimension
Time frame: 18 months
comparison between real bone dimension's changes (from imaging) vs bone dimension's changes on simulated data difference calculated in mm in one situation: - bone dimension's difference calculated on CT scan (difference between pre and post operative bone dimensions) versus bone dimension's difference calculated on models (difference between bone dimensions obtained on model 1 and model 3)
comparison of post surgery changes in real and simulated results regarding bone torsion
Time frame: 18 months
comparison between real bone torsion's changes (from imaging) vs bone torsion's changes on simulated data, difference calculated in degree in one situation: - bone torsion's difference calculated on CT scan (difference between pre and post operative bone torsions) versus bone torsion's difference calculated on models (difference between bone torsions obtained on model 1 and model 3)
comparison of post surgery changes in real and simulated results regarding bone axis
Time frame: 18 months
comparison between real bone axis changes (from imaging) vs bone axis changes on simulated data : anatomical bone axis (corresponding mainly to the diaphyseal axis)) difference calculated in degree in one situation: - bone axis difference calculated on imaging (difference between pre and post operative bone torsion) versus bone torsion's difference calculated on models (difference between bone torsions obtained on model 1 and model 3)
comparison of post surgery changes in real and simulated results regarding bone volume
Time frame: 18 months
comparison between real bone volume changes (from imaging) vs bone volume changes on simulated data difference calculated in mm3 in one situation: - bone volume difference calculated on CT scan (difference between pre and post operative bone volumes) versus bone volume difference calculated on models (difference between bone volumes obtained on model 1 and model 3)
comparison of post surgery changes in real and simulated results regarding relative position of bones in static condition
Time frame: 18 months
comparison between real mechanical angle changes (from imaging) vs mechanical angle changes on simulated data difference between angles (obtained from mechanical bone axis) calculated in degree in one situation: - mechanical angle difference calculated on imaging (difference between pre and post operative mechanical angles) versus mechanical angle difference calculated on models (difference between mechanical angles obtained on model 1 and model 3)
comparison of post surgery changes in real and simulated results regarding ROM's changes
Time frame: 18 months
comparison between real ROM'S changes (from motion analysis) vs ROM's changes on simulated data joint range of motion's difference calculated in degree in one situation: - ROM's difference calculated on motion analysis (difference between pre and post operative ROM) versus ROM's difference calculated on models (difference between ROM obtained on model 1 and model 3)
comparison of post surgery changes in real and simulated results regarding moment changes
Time frame: 18 months
comparison between real moment changes (from motion analysis) vs moment changes on simulated data moment difference calculated in N.m in one situation: - moment difference calculated on motion analysis (difference between pre and post operative moments) versus moment difference calculated on models (difference between moments obtained on model 1 and model 3)
comparison of post surgery changes in real and simulated results regarding pressure changes
Time frame: 18 months
comparison between real pressure changes (from motion analysis) vs pressure changes on simulated data pressure difference calculated in N/cm2 in one situation: - pressure difference calculated on motion analysis (difference between pre and post operative pressures) versus pressure difference calculated on models (difference between pressures obtained on model 1 and model 3)
12 secondary outcomes
correlation of clinical scores and changes in function
Time frame: 18 months
Comparison of post surgery models between real and simulated surgery regarding bone dimension
Time frame: 18 months
Comparison of post surgery models between real and simulated surgery regarding bone torsion
Time frame: 18 months
Comparison of post surgery models between real and simulated surgery regarding bone axis
Time frame: 18 months
Comparison of post surgery models between real and simulated surgery regarding bone volume
Time frame: 18 months
Comparison of post surgery models between real and simulated surgery regarding point-to-surface distance of bone
Time frame: 18 months
Comparison of post surgery models between real and simulated surgery regarding relative position of bones in static condition
Time frame: 18 months
Comparison of post surgery models between real and simulated surgery regarding ROM's changes
Time frame: 18 months
Comparison of post surgery models between real and simulated surgery regarding ground reaction forces changes
Time frame: 18 months
Comparison of post surgery models between real and simulated surgery regarding moment changes
Time frame: 18 months
Comparison of post surgery models between real and simulated surgery regarding pressure changes
Time frame: 18 months
comparison of simulated joint force changes between Pre and post surgery models
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
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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.
Antoine M PERRIER, PHD principal investigator
laboratoire TIMC CNRS
Questions about this trial
What is this clinical trial studying?
A study testing imaging and motion analysis in people with Orthopedic Disorder, run by Centre d'Investigation Clinique et Technologique 805.
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 4 inclusion and 7 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 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Antoine MR PERRIER, PHD (+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?
Evaluation of simulated models regarding relative position of bones in static condition (time frame: 18 months). The study lists 13 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 16 Dec 2020.