An interventional study of Repeated Measurements of Knee Alignment and Kinematics and Computer Guidance of Surgical Actions in Knee Osteoarthritis, Knee Instability and 3D Knee Kinematics, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-12.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
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 :
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.
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Repeated Measurements of Knee Alignment and Kinematics
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.
Device: Computer Guidance of Surgical Actions
Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.
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)
Time frame: 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.
Time frame: 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.
Time frame: On post-operative imaging (six weeks after surgery)
Clinical results
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)
Clinical results
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)
Clinical results
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)
Clinical results
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)
Clinical results
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)
Clinical results
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)
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre hospitalier de l'Université de Montréal (CHUM)