3D Knee KinematicsNCT01661647
3D Kinematic Assessment of the Human Knee During Physical and Daily Life Activities
A study testing 3D knee kinematic assessment under local anesthesia in people with 3D Knee Kinematics, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Problem : Precise and personalized 3D knee kinematic assessment during physical and daily life activities is a challenge; therefore, it was never performed on an important number of individuals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- 3D Knee Kinematics
- What is being tested?
- 3D knee kinematic assessment under local anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients awaiting knee arthroscopy under local anesthesia for a medial meniscal tear
Who cannot join
- Active infection
- Severe swelling of the knee
- Knee flexion contracture
- Knee flexion less than 120 degrees
- Gross limping
- Inability to perform the various motor tasks required by the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: (Étude de la cinématique Tridimensionnelle du Genou Humain Lors de Gestes Sportifs et de la Vie Courante)
Problem : Precise and personalized 3D knee kinematic assessment during physical and daily life activities is a challenge; therefore, it was never performed on an important number of individuals. However, a better understanding of 3D knee kinematics during such activities would allow a better understanding of this often injured joint.
Hypothesis: A new system using personalized 3D bone imaging and a percutaneous bone fixation device that can be used under local anesthesiaallows for precise and reproducible assessment of 3D knee kinematics during physical and daily life activities.
Read more
Objectives :
- To study human knee 3D kinematics during dynamic activities using a novel minimally invasive measuring system
- Investigate the correlations between standard clinical knee laxity tests and measured 3D knee kinematics during dynamic activities
- Conditions
- 3D Knee Kinematics
- Being tested
- 3D knee kinematic assessment under local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D knee kinematic assessment under local anesthesiaDevice
3D knee kinematic assessment under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 3D knee kinematic assessment | Experimental | 3D knee kinematic assessment under local anesthesia Receives: Device: 3D knee kinematic assessment under local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D knee kinematics
The investigators will investigate if 3D knee kinematics can be precisely and safely measured under local anesthesia during various motor tasks (walking, squatting, pivoting, jumping): kinematic data will be analyzed in search of signs of artefact movement and kinematic aberrations, which would indicate problems with the measurement system.
Measured: On the day of the surgery, before knee arthroscopy
Secondary outcomes (1)
Correlation of kinematic data with clinical laxity tests
With the kinematic measurement device attached to the bones of the lower limbs, various knee laxity tests will be performed by a physician while the kinematics of the knee are recorded; correlations will be sought between the subjective evaluation of the physician and the kinematic data.
Measured: On the day of surgery, before knee arthroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study start2 Jul 2025 (estimated)
- Primary completion1 Jul 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 3D Knee KinematicsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT01661647
- Sponsor's protocol ID
- CE 12.005
- Status last verified
- Aug 2024
- First submitted
- 16 Jul 2012
- Last updated
- 7 Aug 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 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Étude de la cinématique Tridimensionnelle du Genou Humain Lors de Gestes Sportifs et de la Vie Courante)
- ClinicalTrials.gov ID
- NCT01661647
- Acronym / sponsor ID
- CE 12.005
- Conditions
- 3D Knee Kinematics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Eiffel Medtech
- Study start
- 2 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 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 : Precise and personalized 3D knee kinematic assessment during physical and daily life activities is a challenge; therefore, it was never performed on an important number of individuals. However, a better understanding of 3D knee kinematics during such activities would allow a better understanding of this often injured joint.
Hypothesis: A new system using personalized 3D bone imaging and a percutaneous bone fixation device that can be used under local anesthesiaallows for precise and reproducible assessment of 3D knee kinematics during physical and daily life activities.
Objectives :
- To study human knee 3D kinematics during dynamic activities using a novel minimally invasive measuring system
- Investigate the correlations between standard clinical knee laxity tests and measured 3D knee kinematics during dynamic activities
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D knee kinematic assessment | Experimental | Device: 3D knee kinematic assessment under local anesthesia3D knee kinematic assessment under local anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients awaiting knee arthroscopy under local anesthesia for a medial meniscal tear
Key exclusion criteria (6 listed)
- Active infection
- Severe swelling of the knee
- Knee flexion contracture
- Knee flexion less than 120 degrees
- Gross limping
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 |
|---|---|---|
| 3D knee kinematic assessment under local anesthesia3D knee kinematic assessment under local anesthesia | Device | 3D knee kinematic assessment |
Primary outcome
3D knee kinematics
Time frame: On the day of the surgery, before knee arthroscopy
The investigators will investigate if 3D knee kinematics can be precisely and safely measured under local anesthesia during various motor tasks (walking, squatting, pivoting, jumping): kinematic data will be analyzed in search of signs of artefact movement and kinematic aberrations, which would indicate problems with the measurement system.
1 secondary outcome
Correlation of kinematic data with clinical laxity tests
Time frame: On the day of surgery, before knee arthroscopy
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 7 Aug 2024.
Related trials for 3D Knee Kinematics
Not yet recruiting
Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration
Knee Osteoarthritis, Knee Instability
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 3D knee kinematic assessment under local anesthesia in people with 3D Knee Kinematics, 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 6 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 7 Aug 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 kinematics (time frame: On the day of the surgery, before knee arthroscopy). 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 7 Aug 2024.