Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration
NCT ID: NCT01674816
Last Updated: 2024-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-12-01
2026-12-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Repeated Measurements of Knee Alignment and Kinematics
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.
Repeated Measurements of Knee Alignment and Kinematics
Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
Computer Guidance of Surgical Actions
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.
Computer Guidance of Surgical Actions
Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.
Interventions
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Repeated Measurements of Knee Alignment and Kinematics
Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
Computer Guidance of Surgical Actions
Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Eiffel Medtech
INDUSTRY
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Principal Investigators
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Frédéric Lavoie, MD, MSc, FRCSC
Role: PRINCIPAL_INVESTIGATOR
CHUM
Locations
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Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Countries
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Central Contacts
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Other Identifiers
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CE12.006
Identifier Type: -
Identifier Source: org_study_id
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