Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration
Primary Purpose
Knee Osteoarthritis, Knee Instability, 3D Knee Kinematics
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Repeated Measurements of Knee Alignment and Kinematics
Computer Guidance of Surgical Actions
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy (HTO), anterior cruciate ligament reconstruction(ACLR))
Exclusion Criteria:
- 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
Sites / Locations
- Centre Hospitalier de l'Université de Montréal (CHUM)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Repeated Measurements of Knee Alignment and Kinematics
Computer Guidance of Surgical Actions
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
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.
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.
Secondary Outcome Measures
Clinical results
The clinical results after surgery will be assessed using patient questionnaire and clinical examination.
Clinical results
The clinical results after surgery will be assessed using the International Knee Society score.
Clinical results
The clinical results after surgery will be assessed using the KOOS score.
Clinical results
The clinical results after surgery will be assessed using the SF-12 score.
Clinical results
The clinical results after surgery will be assessed using the Marx activity scale.
Clinical results
The clinical results after surgery will be assessed through angular and linear measurements using 3D imaging.
Full Information
NCT ID
NCT01674816
First Posted
August 6, 2012
Last Updated
November 10, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Eiffel Medtech
1. Study Identification
Unique Protocol Identification Number
NCT01674816
Brief Title
Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration
Official Title
(Étude de la cinématique Tridimensionnelle du Genou et Guidage Chirurgical Minimalement Effractifs Par Recalage Rigide échographique)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Eiffel Medtech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Instability, 3D Knee Kinematics, Precision of Surgical Actions, Clinical Outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Repeated Measurements of Knee Alignment and Kinematics
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Computer Guidance of Surgical Actions
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Repeated Measurements of Knee Alignment and Kinematics
Intervention Description
Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
Intervention Type
Device
Intervention Name(s)
Computer Guidance of Surgical Actions
Intervention Description
Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.
Primary Outcome Measure Information:
Title
3D knee kinematic assessment
Description
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)
Time Frame
1 day
Title
Precision of guided surgical actions
Description
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.
Time Frame
During surgery
Title
Precision of guided surgical actions
Description
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.
Time Frame
On post-operative imaging (six weeks after surgery)
Secondary Outcome Measure Information:
Title
Clinical results
Description
The clinical results after surgery will be assessed using patient questionnaire and clinical examination.
Time Frame
At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Title
Clinical results
Description
The clinical results after surgery will be assessed using the International Knee Society score.
Time Frame
At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Title
Clinical results
Description
The clinical results after surgery will be assessed using the KOOS score.
Time Frame
At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Title
Clinical results
Description
The clinical results after surgery will be assessed using the SF-12 score.
Time Frame
At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Title
Clinical results
Description
The clinical results after surgery will be assessed using the Marx activity scale.
Time Frame
At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Title
Clinical results
Description
The clinical results after surgery will be assessed through angular and linear measurements using 3D imaging.
Time Frame
At each post-operative visit (six weeks, six months, one year, and two years after surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy (HTO), anterior cruciate ligament reconstruction(ACLR))
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frédéric Lavoie, MD MSc FRCSC
Phone
1-514-890-8000
Ext
25900
Email
fredericlavoiemd@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fidaa Al-Shakfa, MSc
Phone
1-514-890-8000
Ext
26103
Email
f.alshakfa.crchum@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Lavoie, MD, MSc, FRCSC
Organizational Affiliation
CHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Lavoie, MD MSc FRCSC
12. IPD Sharing Statement
Learn more about this trial
Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration
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