Knee OsteoarthritisNCT01674816
Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration
A study testing Repeated Measurements of Knee Alignment and Kinematics and Computer Guidance of Surgical Actions in people with Knee Osteoarthritis and Knee Instability, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Problem: Currently, no system allows precise kinematic assessment of the knee and accurate guiding of orthopedic surgical actions in a minimally invasive fashion. However, such a system would prove useful in the clinical setting to improve the quality of surgical interventions at the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Instability, 3D Knee Kinematics
- What is being tested?
- Repeated Measurements of Knee Alignment and Kinematics and Computer Guidance of Surgical Actions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy (HTO), anterior cruciate ligament reconstruction(ACLR))
Who cannot join
- Active infection
- Atypical morphology and/or alignment of the lower limbs
- Knee instability (other than secondary to ACL deficiency in patients awaiting ACLR)
- Knee flexion contracture of 10 degrees or more
- Knee flexion of less than 120 degrees
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
Frédéric Lavoie, MD MSc FRCSC
About this study
Official title: (Étude de la cinématique Tridimensionnelle du Genou et Guidage Chirurgical Minimalement Effractifs Par Recalage Rigide échographique)
Problem:
Currently, no system allows precise kinematic assessment of the knee and accurate guiding of orthopedic surgical actions in a minimally invasive fashion. However, such a system would prove useful in the clinical setting to improve the quality of surgical interventions at the knee.
Read more
Hypothesis:
A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.
Objectives :
- Demonstrating the capacity of the system to precisely measure 3D knee kinematics
- Quantifying the reproducibility of the kinematic measurements
- Measuring the impact of knee surgical procedures on knee kinematics
- Assessing the correlations between measured articular kinematics and clinical results after knee surgery
- Integrating the novel measuring system to the surgical flow of three knee surgical procedures
- Quantifying the precision and reproducibility of the surgical actions guided by the system
- Comparing the clinical results of surgeries guided by the system to those performed with the traditional technique
Read the detailed description
A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.
- Conditions
- Knee Osteoarthritis, Knee Instability, 3D Knee Kinematics, Precision of Surgical Actions, Clinical Outcomes
- Being tested
- Repeated Measurements of Knee Alignment and Kinematics, Computer Guidance of Surgical Actions
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated Measurements of Knee Alignment and KinematicsDevice
Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
Computer Guidance of Surgical ActionsDevice
Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.
| Study group | Role | What they receive |
|---|---|---|
| Repeated Measurements of Knee Alignment and Kinematics | Active comparator | Patients in the Repeated Measurements Arm will have the kinematic measurement protocol repeated twice before and twice after the surgical procedure; the procedure itself will be performed with the traditional technique, i.e without guidance by the system. Receives: Device: Repeated Measurements of Knee Alignment and Kinematics |
| Computer Guidance of Surgical Actions | Active comparator | Patients in the Computer Guidance of Surgical Actions Arm will have the kinematic measurement protocol performed only once before and once after the surgical procedure; the procedure itself will be performed with guidance by the system. Receives: Device: Computer Guidance of Surgical Actions |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D knee kinematic assessment
The system should be able to precisely and reproducibly measure 3D knee kinematics (tibio-femoral flexion, abduction-adduction, transverse rotation, and anterio-posterior and medio-lateral translations)
Measured: 1 day
Precision of guided surgical actions
The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.
Measured: During surgery
Precision of guided surgical actions
The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.
Measured: On post-operative imaging (six weeks after surgery)
Secondary outcomes (6)
Clinical results
The clinical results after surgery will be assessed using patient questionnaire and clinical examination.
Measured: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results
The clinical results after surgery will be assessed using the International Knee Society score.
Measured: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results
The clinical results after surgery will be assessed using the KOOS score.
Measured: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results
The clinical results after surgery will be assessed using the SF-12 score.
Measured: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results
The clinical results after surgery will be assessed using the Marx activity scale.
Measured: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results
The clinical results after surgery will be assessed through angular and linear measurements using 3D imaging.
Measured: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Eiffel Medtech
- Responsible party
- Sponsor
- Investigators
- Frédéric Lavoie, MD, MSc, FRCSC, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674816
- Sponsor's protocol ID
- CE12.006
- Status last verified
- Feb 2024
- First submitted
- 6 Aug 2012
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Étude de la cinématique Tridimensionnelle du Genou et Guidage Chirurgical Minimalement Effractifs Par Recalage Rigide échographique)
- ClinicalTrials.gov ID
- NCT01674816
- Acronym / sponsor ID
- CE12.006
- Conditions
- Knee Osteoarthritis, Knee Instability, 3D Knee Kinematics, Precision of Surgical Actions, Clinical Outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Eiffel Medtech
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Aug 2012 (estimated)
- 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.
Problem:
Currently, no system allows precise kinematic assessment of the knee and accurate guiding of orthopedic surgical actions in a minimally invasive fashion. However, such a system would prove useful in the clinical setting to improve the quality of surgical interventions at the knee.
Hypothesis:
A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.
Objectives :
- Demonstrating the capacity of the system to precisely measure 3D knee kinematics
- Quantifying the reproducibility of the kinematic measurements
- Measuring the impact of knee surgical procedures on knee kinematics
- Assessing the correlations between measured articular kinematics and clinical results after knee surgery
- Integrating the novel measuring system to the surgical flow of three knee surgical procedures
- Quantifying the precision and reproducibility of the surgical actions guided by the system
- Comparing the clinical results of surgeries guided by the system to those performed with the traditional technique
Detailed description
A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeated Measurements of Knee Alignment and Kinematics | Active comparator | Device: Repeated Measurements of Knee Alignment and KinematicsPatients in the Repeated Measurements Arm will have the kinematic measurement protocol repeated twice before and twice after the surgical procedure; the procedure itself will be performed with the traditional technique, i.e without guidance by the system. |
| Computer Guidance of Surgical Actions | Active comparator | Device: Computer Guidance of Surgical ActionsPatients in the Computer Guidance of Surgical Actions Arm will have the kinematic measurement protocol performed only once before and once after the surgical procedure; the procedure itself will be performed with guidance by the system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy (HTO), anterior cruciate ligament reconstruction(ACLR))
Key exclusion criteria (5 listed)
- Active infection
- Atypical morphology and/or alignment of the lower limbs
- Knee instability (other than secondary to ACL deficiency in patients awaiting ACLR)
- Knee flexion contracture of 10 degrees or more
- Knee flexion of less than 120 degrees
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 |
|---|---|---|
| Repeated Measurements of Knee Alignment and KinematicsRepeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc. | Device | Repeated Measurements of Knee Alignment and Kinematics |
| Computer Guidance of Surgical ActionsComputer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc. | Device | Computer Guidance of Surgical Actions |
Primary outcome
3D knee kinematic assessment
Time frame: 1 day
The system should be able to precisely and reproducibly measure 3D knee kinematics (tibio-femoral flexion, abduction-adduction, transverse rotation, and anterio-posterior and medio-lateral translations)
Precision of guided surgical actions
Time frame: During surgery
The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.
Precision of guided surgical actions
Time frame: On post-operative imaging (six weeks after surgery)
The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.
6 secondary outcomes
Clinical results
Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results
Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results
Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results
Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results
Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Clinical results
Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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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.
Frédéric Lavoie, MD, MSc, FRCSC principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated Measurements of Knee Alignment and Kinematics and Computer Guidance of Surgical Actions in people with Knee Osteoarthritis and Knee Instability, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Feb 2024. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric Lavoie, MD MSc FRCSC (1-514-890-8000 ext. 25900, fredericlavoiemd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D knee kinematic assessment (time frame: 1 day). 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 12 Feb 2024.